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What does Trump’s order on deregulation mean for the chemicals industry?

The recent executive order on “unleashing prosperity through deregulation” instructs federal agencies to carry out the Trump administration’s deregulatory agenda, calling on each agency to eliminate at least 10 regulations for every new one it issues or proposes. The move casts uncertainty over the future of many Toxic Substances Control Act (TSCA) rules finalized or planned by the previous administration.

By Xiaolu Wang, Esq., Julia John, MS | Feb 12, 2025 4:40 PM EST

Regulatory background: Trump’s deregulatory agenda

  • President DONALD TRUMP centered the new EPA’s mission on deregulation in a November statement announcing LEE ZELDIN as his pick to be the agency’s administrator. Zeldin “will ensure fair and swift deregulatory decisions that will be enacted in a way to unleash the power of American businesses,” Trump wrote.
  • The deregulatory stance echoes that of the first Trump administration. A 2017 executive order, EO 13771, on “reducing regulation and reducing regulatory costs,” directed federal agencies to “identify at least two existing regulations to be repealed” for every new issued or proposed regulation. The EO also blocked agencies from issuing regulations not included on the most recent unified regulatory agenda. A month after releasing EO 13771, Trump followed up by directing each agency to create a regulatory reform task force he said would “ focus on eliminating costly and unnecessary regulations.” The administration repealed 5½ regulations for every new one issued, according to a White House fact sheet. 
  • The Heritage Foundation’s Project 2025 – a conservative executive branch blueprint published in 2023 that Trump seems to be following – took issue with the Biden EPA’s approach to risk evaluations for existing chemicals under the Toxic Substances Control Act (TSCA). The think tank called for “focus[ing] the scope of chemical evaluations on pathways of exposure that are not covered by other program offices and other environmental statutes.” The EPA should “eliminate scope creep to ensure that evaluations can be completed in a timely manner consistent with the statutory requirements,” the organization wrote. Additionally, according to Project 2025, TSCA section 6 risk evaluation and management rules should presume that workplaces meet Occupational Safety and Health Administration (OSHA) requirements for personal protective equipment (PPE) use.

EO: ‘Unleashing prosperity through deregulation’

  • The second Trump administration’s EO on “ unleashing prosperity through deregulation,” released Jan. 31, builds on EO 13771. The new order, EO 14192, calls on each federal agency to identify at least 10 regulations for withdrawal for every new one it issues or proposes in fiscal year 2025. The goal is “to significantly reduce the private expenditures required to comply with Federal regulations to secure America’s economic prosperity and national security” and “ensure that the cost of planned regulations is responsibly managed and controlled through a rigorous regulatory budgeting process.”
  • Under the EO, the EPA and other agencies must “ensure that the total incremental cost of all new regulations, including repealed regulations, being finalized this year shall be significantly less than zero,” as determined by the Office of Management and Budget (OMB). The EO requires any incremental costs linked to new regulations to be offset by eliminating costs from at least 10 existing regulations.
  • The EO also directs the OMB to provide guidance on implementing the regulatory cap, including standards to measure regulatory costs and “methods to oversee the issuance of rules with costs offset by savings at different times or different agencies.” The order doesn’t specify timelines for the guidance’s publication.
  • For future fiscal years, the EO instructs agencies to identify offsetting regulations for those expected to increase incremental cost and estimate total costs or savings for each new or repealed regulation in regulatory plans submitted to the OMB. The OMB must identify “a total amount of incremental costs that will be allowed for each agency in issuing new regulations and repealing regulations” during the annual presidential budget process.
  • Like EO 13771, the new EO generally prohibits agencies from issuing regulations not included in the most recent unified regulatory agenda and mandates OMB approval for any addition or removal of regulations on the agenda. This restriction on unplanned regulatory activities means the EPA will no longer be able to deviate much from objectives laid out in the agenda.
  • Notably, the EO’s definition of “regulation” encompasses rules, memoranda, administrative orders, guidance documents, policy statements and interagency agreements. Therefore, the EPA may hold or pull back many kinds of actions under the order.

TSCA rules vulnerable to repeal

  • Several TSCA risk evaluation and management rules for existing chemicals could be on the Trump EPA’s rollback list. A Jan. 20 EO on “ initial rescissions of harmful executive orders” revoked a TSCA-related Biden EO on “protecting public health and the environment.” This suggests that the new EPA’s stance aligns with Project 2025 and that certain industry-opposed TSCA section 6 rules the Biden administration finalized last year could be withdrawn and redone.
  • The Biden EO had prompted the previous EPA to  revisit all “first 10” TSCA risk evaluations completed by the first Trump administration. The agency redid most of the assessments with various risk evaluation policy changes, including removing a Trump-era assumption of proper workplace PPE use, evaluating additional exposure routes such as air, water or disposal exposures to the general population, and explicitly considering “ fenceline communities” near industrial sites. Moreover, the Biden EPA adopted a “ whole chemical approach,” making a single determination on a substance’s unreasonable risk of health or environmental injury instead of separate determinations per condition of use (COU). In a December letter to Trump, the National Association of Manufacturers (NAM) and dozens of other industry groups described the Biden administration’s consideration of exposures as too conservative and prompting “unnecessary regulation.”
  • The Trump EPA could withdraw several TSCA section 6(a) risk management rules resulting from the Biden-era revised risk determinations and reverse the underlying evaluation approach, including for the solvents trichloroethylene (TCE), perchloroethylene (PCE), carbon tetrachloride (CTC) and methylene chloride. The new EPA has already postponed the TCE rule’s effective date from January to March, pursuant to a regulatory freeze intended to allow review of any relevant “questions of fact, law, and policy” for formally published rules yet to take effect. The agency may further delay the effective date, with a potential opportunity for public comment, and pursue similar action on other rules issued in the final days of the Biden administration, such as those on PCE and CTC.
  • Meanwhile, the EPA is likely to scrutinize and modify 2024 risk management proposals for 1-bromopropane (1-BP), C.I. pigment violet 29 (PV29) and n-methylpyrrolidone (NMP) with an eye toward reducing any associated regulatory burdens, possibly further delaying the already overdue final rules.
  • The EPA will likely also repeal a 2024 procedural rule codifying the Biden administration’s TSCA risk evaluation approach. The EPA may think the rule causes “scope creep” because it requires the agency to evaluate all “known, intended or reasonably foreseen” COUs for a substance – including all exposure pathways – and added “overburdened communities” to the regulatory definition of potentially exposed or susceptible subpopulation (PESS). [ Read AgencyIQ’s analysis on the rule.]
  • Furthermore, the EPA could withdraw a December rule looking to enhance the efficiency of TSCA section 5 premarket reviews and better align the regulations with the 2016 Lautenberg amendments. According to the American Chemistry Council (ACC), however, the Biden EPA “missed an opportunity to improve the predictability and timeliness of the TSCA New Chemicals program” with the rule, which took effect Jan. 17. The rule also codified a Biden-era policy making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs). This provision “has hamstrung the ability to supply small quantities of critical substances” and “threatens vital industries,” the ACC wrote – potential impacts that could provide a strong rationale for the agency to repeal the rule. [ Check out AgencyIQ’s analysis on the rule.]

PFAS rules that may be withdrawn

  • Other industry-criticized Biden-era rules addressing PFAS are also candidates for the chopping block. They include the 2023 TSCA section 8(a) reporting rule compelling companies – including article importers – to submit information on their use of roughly 1,500 PFAS going back to 2011. In their recent letter to Trump, NAM and the other trade organizations wrote that the rule “will only serve to impose significant costs on manufacturers of all sizes.”
  • Additionally, the EPA will probably roll back 2024 PFAS drinking water limits under the Safe Drinking Water Act (SDWA). The agency will likely do the same with hazardous substance designations for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) established last year to make releasers of the compounds fund cleanup activities under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The industry groups asked Trump “to pause these PFAS rulemakings and listings, and instead take an incremental approach to PFAS that first addresses the higher risk non-polymer PFAS chemicals.” [ See AgencyIQ’s analysis on the Biden EPA’s PFAS actions.]

Potential impacts

  • So, what does EO 14192 on “unleashing prosperity through deregulation” mean for the chemicals industry? The order raises questions about the future of many chemicals-related rules finalized or proposed by the previous administration. Trump’s deregulatory agenda will probably limit regulatory activities affecting the industry, at least in the near term. Companies may face fewer compliance obligations after seeing a flurry of TSCA rules and other chemicals-related actions toward the end of the Biden administration. However, a 2021 Government Accountability Office (GAO) report concluded that the first Trump administration’s deregulatory EOs “did not substantially change selected agencies’ processes or procedures,” at the EPA and four other agencies. The new EO could have more impact because it sets out a 10-to-1 deregulatory goal — five times greater than that of EO 13771. Several Biden-era chemicals rules were met with legal challenges after their release, so the new EPA may seek voluntary remand to pull back the regulations and modify them.
  • EPA regulatory repeals would probably trigger more lawsuits from environmental groups, especially for statutorily mandated, timebound actions such as TSCA risk management rules and the PFAS reporting rule. Legal challenges might result in court orders and court-enforced deadlines for further rulemaking, especially in a post-Chevron world, where the agency’s interpretation of federal statutes no longer receives automatic deference. To defend a regulatory rollback under TSCA in court, the EPA would need to show it is using the “best reading” of the law, a standard that may hurt or help the deregulatory effort depending on how well the agency makes its case. [ Check out AgencyIQ’s analysis on the 2024 Supreme Court decision overturning Chevron deference.]
  • Litigation would increase uncertainty around the EPA’s regulatory activities, potentially complicating compliance for industry. Regardless of what happens, companies should keep careful track of the agency’s regulatory and deregulatory activities under the new administration to stay on top of their obligations over the coming years. [ Read AgencyIQ’s analysis for more on the Trump administration’s initial actions.]

To contact the authors of this item, please email Xiaolu Wang (xwang@agencyiq.com) and Julia John (jjohn@agencyiq.com).
To contact the editor, email Jason Wermers (jwermers@agencyiq.com).

Key documents, dates

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AgencyIQ by POLITICO and POLITICO Newsletters

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By Scott Stephens, MPA

In the internet age, meeting regulatory obligations starts with knowing where to pinpoint the right resources in the vast ocean of information to guide you successfully through the often-labyrinthine processes of EU chemicals regulation. he good news: ECHA offers a treasure trove of online guidance on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Classification, Labelling and Packaging (CLP), and other chemicals legislation, as well as other reference tools to help industry keep products in compliance.

Fill out the form to read the full article.

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An introduction to EU chemicals guidance

In the internet age, meeting regulatory obligations starts with knowing where to pinpoint the right resources in the vast ocean of information to guide you successfully through the often-labyrinthine processes of EU chemicals regulation. The good news: ECHA offers a treasure trove of online guidance on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Classification, Labelling and Packaging (CLP), and other chemicals legislation, as well as other reference tools to help industry keep products in compliance. The not-so-good news: finding them and understanding their purpose are not always easy tasks. Here, AgencyIQ offers a quick overview of ECHA’s most essential resources that every regulatory affairs professional should have at their fingertips.

BY Scott Stephens, MPA | Aug 26, 2024 4:21 PM CDT

Background on EU chemicals regulatory guidance

  • So-called REACH implementation projects (RIPs) served to develop the first series of guidance resources intended to help stakeholders meet their obligations under the REACH and CLP Regulations (1907/2006/EC and 1272/2008/EC), EU’s principal cross-sectoral chemicals legislation. After the initial versions of these documents were drafted through RIPs – undertakings that were spearheaded by the European Commission, with input and participation from non-governmental organizations (NGOs), industry representatives and member-state authorities – the responsibility of maintaining and further developing guidance was assigned to ECHA, as anchored in the provisions of REACH (Article 77) and CLP (Article 50) concerning the core duties of the agency.
  • Today, the steps for creating chemical regulatory guidance are laid down in ECHA documents, including the Provision of new guidance and guidance update (PRO-0012) and the Consultation procedure for guidance (PRO-0011.11). They establish the formal rules for drafting new and updating existing guidance, providing a key role for stakeholders to play in formulating these documents.
  • “The procedure includes the organisation and management of the consultation with ECHA partners intended to ensure a broad acceptance of the guidance,” as stated in the purpose section of the Consultation procedure for guidance. That is, obtaining buy-in from all stakeholders affected by the guidance is central to ECHA’s objectives. See the flowchart on page 7 of the Consultation procedure document for a succinct overview of guidance development and consultation steps, including interaction between partner expert groups (PEG); ECHA committees (e.g., risk assessment committee – RAC); the Enforcement Forum; the Commission; and member-state authorities.

Scope and type of guidance

  • ECHA offers a whole host of resources on its website, providing clarification on many aspects of the chemicals legislation under the agency’s remit. As can be seen by visiting this main page on guidance under the “ Support” tab, ECHA provides guidance in several different formats, including (1) detailed guidance documents addressing the legislation under ECHA’s purview (so far, limited to REACH, CLP, Biocidal Products Regulation (BPR – 528/2012/EU) and the Prior Informed Consent Regulation (PIC – 649/2012/EU)); (2) fact sheets, which detail specific regulatory elements, primarily for REACH and CLP, not otherwise covered by the guidance documents (e.g., the public classification and labeling (C&L) inventory, cost elements in data sharing under REACH, compliance with the CLP when manufacturing candles); and (3) “ Guidance in a nutshell,” which, as the title implies, presents a concise rundown of various chemicals legislation features.
  • The agency has several other useful resources beyond reference materials explaining EU chemicals legislation. These include (1) practical guides, which clarify specific aspects of compliance based on real-life examples and best practice (e.g., “how to use and report (Q)SARs?”); (2) ongoing guidance consultations providing insight into which guidance documents are currently under review and where they are in the updating process; formats and templates that facilitate certain tasks under REACH and other chemicals legislation, like providing a uniform template for compiling the chemical safety report (CSR); and (3) manuals on preparing REACH and CLP dossiers in the International Uniform Chemical Information Database (IUCLID) environment.
  • ECHA hosts a valuable questions and answers (Q&A) database, which allows users to input questions in free form using keywords. The database also includes extensive filtering capabilities, enabling searches based on predetermined topics (e.g., REACH, CLP, BPR, PIC), scopes (e.g., cosmetics, safety data sheets, evaluation, registration) and chapters. It includes a helpful four-minute-long video tutorial on using the database’s functionalities.

Chemicals regulation guidance needs

  • Which guidance you’re interested in learning more about will obviously depend on your current level of understanding of the EU’s chemicals framework and what your particular chemical regulatory compliance needs are.
  • For absolute beginners or those who want to understand whether they have any obligations at all under REACH, the CLP, or other relevant parts of the EU chemicals framework, the “ Getting started” page under ECHA’s Support tab is probably the best place to begin. This page provides a batch of various questions which, when answered, can help point the user in the right direction.
  • For more sophisticated users, already conversant in EU chemical regulation and with an idea about what they’re looking for, the Support tab provides an excellent overview of and one-stop-shop access to all possible types of guidance and other regulatory resources, including (1) links to the guidance documents at the bottom of the page; (2) various tools addressing different chemical regulatory elements, such as the chemical safety assessment and reporting tool (Chesar) under REACH and SCIP, the database for information on Substances of Concern in articles as such or in complex objects (Products), established under the Waste Framework Directive (WFD); and (3) the Q&A page.
  • Finally, the Support tab provides users links to contact the authorities to obtain regulatory (REACH, CLP, BPR, PIC, etc.), technical (IUCLID, REACH-IT, chemical data on ECHA website, etc.), and other types of support (e.g., invoicing, access to documents, speaking requests).

To contact the author of this piece, email Scott Stephens ( sstephens@agencyiq.com).
To contact the editor of this item, please email Jason Wermers ( jwermers@agencyiq.com).

Key Documents and Dates

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By Sebastian Godoy, MPH, Corey Jaseph, MS, RAC, Kari Oakes

In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations and comment periods.

Fill out the form to read the full article.

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What we expect European regulators to do in September 2024

In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations and comment periods. Given the expansive and complex European life sciences regulatory landscape, we’ll be including updates from key EU and national regulators. The goal: to allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts.

By Sebastian Godoy, MPH, Corey Jaseph, MS, RAC, Kari Oakes | Oct 25, 2023 5:20 PM CDT | Updated Aug 29, 2024 2:07 PM CDT

What we expect to be talking about in September:

  • August was relatively quiet, with much of Europe taking advantage of the summer holidays, so this and our prior EU monthly calendar largely focused on September activities.
  • Events and deadlines will pick up in September, likely leading to a busy fall. Major European regulators, national competent authorities, and interest groups are planning to host several webinars and trainings throughout September. For example, the EMA will host an information session on its newly launched pilot for expert panels’ advice for orphan medical devices on September 23. For qualifying manufacturers, the medical device expert panels will offer advice on whether particular devices meet the criteria of orphan device and on the clinical data needed to support those devices.
  • Legislative affairs will also likely pick up. Now that URSULA VON DER LEYEN has secured the European Commission’s top job and is organizing the Commission’s membership, Hungary has taken over the presidency of the Council of the EU, and key Parliament committees have elected their leadership teams, it is likely that legislators will begin seeing to their health agendas. For example, Parliament comes out of its recess on September 2, and there are already two Environment, Public Health and Food Safety (ENVI) committee meetings set on the docket, for September 4 and 12. Given that the Commission and Parliament were consumed with external and internal summer elections, there are still several health areas that legislators are discussing, such as critical medicine shortages and reducing the burden of cancer, not to mention the pending pharma reform package.
  • Additionally, with the World Health Organization (WHO) recently declaring mpox a global public health threat, legislators may also consider the EU’s emerging disease preparedness and mitigation measures. For example, the outgoing EU Health Commissioner STELLA KYRIAKIDES called on Member States’ health ministers to support Africa in managing the outbreak, especially since the African CDC said it will need 10 million vaccines to control the spread of mpox. According to recent reporting from our colleagues at POLITICO, the EU has already pledged to donate 215,000 mpox vaccines via the Commission’s Health Emergency Preparedness and Response Authority (HERA), and Germany and France have each pledged 100,000 vaccines. These efforts also come at a time when the EU is actively trying to build on African partnerships, with the Commission pledging 10 million euros in January to help the EMA’s efforts to operationalize the African Medicines Agency.
  • Expect to see guidance on the impact of new and amended regulations on device manufacturers: While we did see the MDR/IVDR amendment in early July, we are still expecting to see more guidance on how to operationalize those changes. The amendment extended the transition period for diagnostics, allowed for a phased rollout of EUDAMED and introduced a requirement for manufacturers to report on critical device shortages to regulators and other affected stakeholders. We expect to see guidance soon on how the EUDAMED change impacts manufacturers and how to operationalize device shortage reporting. Second, both the Artificial Intelligence Act and the regulation on substances of human origin impact device and diagnostics manufacturers appeared in the Official Journal in July, so expect Commission guidance soon on the intersection of the MDR and IVDR with these two pieces of legislation.
  • The Medical Device Coordination Group has a backlog of guidance documents to publish. Planned for Q1 or Q2 this year were guidance documents on creating corrective and preventive action plans, updates to the manufacturer incident report (MIR) form, postmarket surveillance, a paper on products intended to disinfect or sterilize medical devices, and several updates to existing guidance. [ See AgencyIQ’s medical device guidance tracker for more information].

Upcoming meetings

The following list encapsulates meetings expected for the month of September for various European bodies and committees. The information below includes the event type and whether the meeting can be attended (Open) or not (Closed).

Start Date End Date Event Event Type Organization
9/2/2024 9/2/2024 EUCOPE’s Life Science Lectures – EHDS Webinar (OPEN) EUCOPE
9/2/2024 9/17/2024 4th Training Course on Quality Management for Tissue Establishments Training (OPEN) European Directorate for the Quality of Medicines and HealthCare (EDQM)
9/3/2024 9/3/2024 Procurement Working Party Committee Meeting (CLOSED) British In Vitro Diagnostics Association (BIVDA)
9/4/2024 9/4/2024 MDCG – International matters subgroup meeting Committee Meeting (CLOSED) Medical Device Coordination Group (MDCG) / European Commission
9/4/2024 9/4/2024 ENVI meeting Committee Meeting (OPEN) Environment, Public Health and Food Safety (ENVI)
9/4/2024 9/4/2024 Masterclass – how to unlock the potential of data sharing in collaborative projects Training (OPEN) European Federation of Pharmaceutical Industries and Associations (EFPIA)
9/5/2024 9/5/2024 Towards an EU Coordination Plan for the Brain: Insights from the Community Webinar (OPEN) EU Health Policy Platform (EUHPP) / Cancer Image Directorate-General for Health and Food Safety (DG SANTE)
9/6/2024 9/6/2024 UKCA Sub-Group Seminar (OPEN) British In Vitro Diagnostics Association (BIVDA)
9/9/2024 9/9/2024 NIS-2 Directive in medical technology: Cyber and information security Webinar (OPEN) German Medtech trade organization (BVMed)
9/10/2024 9/10/2024 BASG discussion: Clinical trials of medical devices and performance studies of in-vitro diagnostics 2024 Webinar/ Seminar (OPEN) Austrian Federal Office for Safety in Health Care (BASG)
9/10/2024 9/12/2024 XEVMPD training course Training (OPEN) eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) / EMA
9/11/2024 9/11/2024 How to advance precision medicine for Europe’s cancer patients with AI-powered imaging Webinar
(OPEN)		 EU Health Policy Platform (EUHPP) / Cancer Image Directorate-General for Health and Food Safety (DG SANTE)
9/11/2024 9/11/2024 CTR Collaborate Stakeholder meeting, supported by ACT EU Webinar (OPEN) Clinical Trial Regulation (CTR) / Accelerating Clinical Trials in the E.U. (ACT EU) / Clinical Trials Coordination Groups (CTCG)
9/11/2024 9/11/2024 Public launch event on the guideline on good pharmacovigilance practices Module XVI on risk minimization measures and its Addendum II Webinar (OPEN) EMA
9/12/2024 9/12/2024 ENVI meeting Committee meeting (OPEN) Environment, Public Health and Food Safety (ENVI)
9/13/2024 9/13/2024 Point-Of-Care 3D printing and medical device manufacturing Conference (OPEN) Helsinki University Hospital (HUS)
9/16/2024 9/20/2024 IMRDF 26th Session Conference (OPEN) International Medical Device Regulators Forum (IMDRF)
9/16/2024 9/20/2024 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system Webinar (OPEN) International Standards Organization (ISO) / International Council for Harmonization / EMA
9/17/2024 9/17/2024 MHRA Board Meeting Committee Meeting (OPEN) U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA)
9/17/2024 9/18/2024 Annual Regulatory Affairs Seminar Seminar (OPEN) British In Vitro Diagnostics Association (BIVDA)
9/182024 9/18/2024 Meeting of the Executive Steering Group on MSSG – September 2024 Webinar (OPEN)

Shortages and Safety of

Medicinal Products (MSSG)
9/18/2024 9/18/2024 Fourth Symposium of the Center for Rare Diseases Symposium/ Conference (Open) Jena Center for Rare Diseases
9/18/2024 9/18/2024 Clinical Trials Information System (CTIS): walk-in clinic Webinar (OPEN) EMA
9/19/2024 9/19/2024 Workshop on EU drug precursors regulations Webinar (OPEN) Polish Chief Pharmaceutical Inspectorate / European Commission
9/20/2024 9/20/2024 External Affairs Working Party Webinar/ Seminar (OPEN) British In Vitro Diagnostics Association (BIVDA)
9/20/2024 9/20/2024 EMA Account Management, what’s new? Webinar (OPEN) EMA
9/23/2024 9/23/2024 Information session on the pilot for expert panels’ advice for orphan medical devices Webinar (OPEN) EMA
9/23/2024 9/24/2024 EFLM Strategic Conference 2024 – A vision to the future: Value-based Laboratory Medicine Conference (OPEN) European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
9/23/2024 9/26/2024 EMA CTIS – Sponsor user training program Webinar
(OPEN)		 Clinical Trial Information System (CTIS) / EMA
9/24/2024 9/24/2024 Multi-stakeholder workshop on Pharmacogenomics Webinar
(OPEN)		 EMA
9/24/2024 9/25/2024 Unlocking the MDR/IVDR for Innovators in Europe Conference (OPEN) Notified Body Increased Capacity (NoBoCap)
9/24/2024 9/25/2024 DIA Medical Information and Communications Conference Conference (OPEN) DIA
9/25/2024 9/25/2024 Clinical trial discussions: perspectives on clinical drug research Webinar (OPEN) Tukija / Fimea
9/25/2024 9/25/2024 Joint HMA/EMA multi-stakeholder workshop on submission predictability Webinar (OPEN) Heads of Medicines Agency (HMA) / EMA
9/26/2024 9/28/2024 19th German Allergy Congress Symposium (OPEN) Paul Ehrlich Institute (PEI)
9/28/2024 9/28/2024 Patient Symposium on Hereditary Retinal Diseases Symposium (OPEN) PRO RETINA Germany eV / University Eye Clinic Tübingen / BfArM
9/30/2024 9/30/2024 ABHI UK HealthTech Conference 2024 Conference (OPEN) Association of British HealthTech Industries (ABHI)
9/30/2024 10/2/2024 TOPRA Symposium 2024 Conference (OPEN) The Organization for Professionals in Regulatory Affairs (TOPRA)

Medicine products pending European Commission decision following CHMP opinion

Below are the drug or biologic products for which decisions are expected to occur within the next two months, according to AgencyIQ’s review of opinions from the EMA’s Committee for Medicinal Products for Human Use (CHMP). The products captured in the following table all received a positive opinion or are awaiting a re-examination from the CHMP.

A quick note: At the time of this calendar’s publication, CHMP had not released its meeting highlights from its August meeting, so we cannot update the table below with the next group of drugs that await an EC decision. Once the highlights have been published, we will update our calendar accordingly.

Anticipated
EC Decision		 Drug Indication Company
August 2024 Tauvid (flortucipir) Diagnosis of Alzheimer’s Eli Lilly Nederland B.V.
August 2024 Winrevair (sotatercept) Pulmonary arterial hypertension (PAH), in combination with other PAH therapies WHO Functional Class (FC) II to III Merck Sharp & Dohme B.V.
N/A (The EMA is currently re-evaluating its opinion) Masitinib AB Science (masitinib) Amyotrophic Lateral Sclerosis AB Science
N/A (The EMA is currently re-evaluating its opinion) Syfovre (pegcetacoplan) Geographic atrophy (advanced age-related macular degeneration) Apellis Netherlands B.V.
September 2024 Anzupgo (delgocitinib) Moderate to severe chronic hand eczema LEO Pharma A/S
September 2024 Iqirvo (elafibranor) Primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) Ipsen Pharma
September 2024 Kayfanda (odevixibat) Cholestatic pruritus in Alagille syndrome (ALGS) Ipsen Pharma
September 2024 Loqtorzi (toripalimab) Metastatic nasopharyngeal carcinoma, in combination with cisplatin and gemcitabine TMC Pharma (EU) Limited
September 2024 Vevizye (ciclosporin) severe dry eye disease (keratoconjuctivitis sicca) Novaliq GmbH
September 2024 Vyloy (zolbetuximab) Locally advanced unresectable or metastatic HER2‑negative gastric or gastro-esophageal junction (GEJ) adenocarcinoma whose tumors are Claudin (CLDN) 18.2 positive, in combination with fluoropyrimidine- and platinum-containing chemotherapy Astellas Pharma Europe B.V.
September 2024 Yuvanci (macitentan / tadalafil) Long-term treatment of PAH in adult patients of WHO FC II to III Janssen-Cilag International NV
September 2024 Eksunbi (ustekinumab)* Moderate to severe plaque psoriasis in children and adolescent patients, ages 6 and older Samsung Bioepis NL B.V.
September 2024 Fymskina (ustekinumab)* Plaque psoriasis Formycon AG
September 2024 Ituxredi (rituximab)* (1) Non-Hodgkin’s lymphoma (NHL);
(2) Chronic lymphocytic leukemia (CLL);
(3) Rheumatoid arthritis
(4) Pemphigus vulgaris		 Reddy Holding GmbH
September 2024 Otulfi (ustekinumab)*

(1) Plaque psoriasis;
(2) Pediatric plaque psoriasis;
(3) Psoriatic arthritis (PsA);

(4) Crohn’s disease

 Fresenius Kabi Deutschland GmbH
September 2024 Ranibizumab Midas (ranibizumab)*

(1) Neovascular (wet) age-related macular degeneration (AMD);

(2) Diabetic macular oedema (DME);

(3) Proliferative diabetic retinopathy (PDR)

(4) Visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)

(5) Visual impairment due to choroidal neovascularisation (CNV)

 Midas Pharma GmbH
September 2024 Tuznue (trastuzumab)* (1) Breast Cancer (metastatic and early cancer);
(2) Metastatic gastric cancer		 Prestige Biopharma Belgium BVBA
September 2024 Axitinib Accord (axitinib)** Advanced renal cell carcinoma (RCC) Accord Healthcare S.L.U.
N/A (EMA currently re-evaluating its opinion after negative decision) Leqembi (lecanemab) Mild cognitive impairment (memory and thinking problems) due to Alzheimer’s disease Eisai GmbH and Biogen

*Biosimilar
**Generic

Notable public consultation periods and calls for evidence

Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q3 2024.

Comment periods for EMA documents (such as concept, reflection, and guidance papers) generally stay open for at least six months, though these timelines can vary drastically. Legal acts (e.g., regulation, direction, decision) proposed by the European Commission are also open for public feedback for varying lengths of time.

Title Type Deadline
ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines [EMA] Scientific guideline 8/30/2024
Revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling [EMA] Concept paper 8/31/2024
Use of real-world data in non-interventional studies to generate real-world evidence [EMA] Reflection paper 8/31/2024
Call for external experts for the SCHEER WG on risks for the health associated to the use of brain stimulators not having an intended medical purpose described in group 6 of Annex XVI to Regulation (EU) 2017/745 [European Commission] Call for scientific opinions 8/31/2024
Revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling [EMA] Concept paper 8/31/2024
Use of real-world data in non-interventional studies to generate real-world evidence [EMA] Reflection paper 8/31/2024
In vitro diagnostic medical devices – common specifications [European Commission] Implementing regulation 9/16/2024
Concept paper on the revision of the COVID-19 vaccines guidance documents [EMA] Concept paper 9/30/2024
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis [EMA] Concept paper 9/30/2024
Nilotinib hard capsules 50, 150 and 200 mg [EMA] Product-specific bioequivalence guidance 9/30/2024
Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg, product-specific bioequivalence guidance [EMA] Product-specific bioequivalence guidance 9/30/2024
Budesonide, gastro-resistant hard capsules, 3 mg, gastro-resistant granules, 9 mg [EMA] Product-specific bioequivalence guidance 9/30/2024
Budesonide, prolonged release tablets, 9 mg [EMA] Product-specific bioequivalence guidance 9/30/2024
Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidance [EMA] Product-specific bioequivalence guidance 9/30/2024

Guidelines effective in September

The following guidelines will come into effect during September after going through the legislative process (which typically involves steps such as completing a public consultation period, draft period, and adoption by the appropriate party). Once in effect, these guidelines embody regulatory processes and policy and can be relied upon by stakeholders.

Guideline Description Effective date
Guideline on the environmental risk assessment of medicinal products for human use – Revision 1 [EMA] Scientific guideline 9/01/2024

Regulatory actions expected in September

This list, based on AgencyIQ analysis, contains a variety of regulatory happenings that are expected to occur in August and September across Europe.

Expected action Description of action Date
EU rules on medical devices and in vitro diagnostics – Targeted evaluation [European Commission] Upcoming call for evidence and public consultation Q3 2024

Other deadlines occurring in September

This list incorporates various deadlines that AgencyIQ is aware are occurring during August and September. These include, but are not limited to, calls for applicants, expressions of interest and surveys.

Program Agency Deadline
Public consultation: Good machine learning practice for medical device developments (guiding principles) International Medical Device Regulators Forum (IMDRF) 8/30/2024
     
Public consultation: Draft CVSWP consolidated 3-year rolling work plan 2025-2027 EMA’s Cardiovascular Working Party (CVSWP) 9/15/2024
Call for expression of interest: Selection procedure to appoint representatives to the PRAC [Pharmacovigilance Risk Assessment Committee, EMA] EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) 9/15/2024
Public consultation: Artificial Intelligence (AI) Act: Trustworthy General-Purpose AI European Commission’s AI Office 9/18/2024
Public consultation: Draft CNSWP consolidated 3-year rolling work plan 2025-2027 EMA’s Central Nervous Working Party (CNSWP) 9/30/2024

Pending EU legislation

The list below includes legislation proposed by the European Commission that is yet to be published. Notably, the adoption timeframes indicated by the Commission are not always strictly adhered to and may be subject to delay.

Under ordinary legislative procedure, once adopted, a Commission proposal is forwarded to the EU’s co-legislators – the Council of the EU and the European Parliament.

Delegated and implementing legal acts are not taken up by the co-legislators after they are proposed by the Commission and are subject to a faster procedure. For delegated acts, the co-legislators usually have two months to object to the proposals but cannot amend them. For implementing acts, the Commission is required to consult with a committee before adoption.

Title Type of act Planned Adoption
Medicines for children & rare diseases – updated rules Proposal for a regulation Originally anticipated for Q1 2023; some provisions included in proposed pharmaceutical regulation
Reform of the EU pharmaceutical legislation Proposal for a regulation and a directive Commission and Parliament endorsed texts, Council draft pending
European Health Data Space Implementing regulation Parliament and Council endorsed, will enter in the Official Journal of the EU sometime in autumn
Performance of pharmacovigilance activities for human medicines (update of Implementing Regulation (EU) 520/2012) Implementing regulation Commission adoption was planned for Q2 2024
Health technology assessment – procedural rules for assessing and managing conflicts of interest Implementing regulation Commission adoption was planned for Q2 2024
Report on the General Data Protection Regulation Report Commission adopted on July 25
Review of the Health Emergency Preparedness and Response Authority (HERA) Report Was planned for Q2 2024
Health technology assessment – cooperation with the EMA Implementing regulation 2024 public consultation period closed, Commission adoption was planned for Q2 2024
Performance of pharmacovigilance activities for human medicines (update of Implementing Regulation (EU) 520/2012) Implementing regulation Anticipated for Q2 2024
Health technology assessment – joint clinical assessments of medical devices Implementing regulation Commission adoption anticipated for Q4 2024 Member State Coordination Group on HTA adopted two guidances on 6/10/2024; Commission adoption anticipated for Q4 2024
Serious Cross-Border Threats to Health Regulation – Evaluation Report Anticipated for Q4 2024
Health technology assessment – joint scientific consultations on medical devices & in vitro diagnostic medical devices Implementing regulation Anticipated for Q4 2024
EU rules on medical devices and in vitro diagnostics (targeted evaluation) Report

Anticipated for Q4 2025

(Public consultation planned for Q3 2024)

To contact the author of this resource, please email Sebastian Godoy ( sgodoy@agencyiq.com).
To contact the editors of this resource, please email Kari Oakes ( koakes@agencyiq.com) / Jason Wermers (jwermers@agencyiq.com).

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By Laura DiAngelo, MPH

The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large. The meeting, scheduled for October 2024, will seek input and recommendations from the committee on the process for informed consent, “new areas of focus” for informed consent, and recent policy on “key information.”

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FDA AdComm to discuss patient-centric informed consent

The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large. The meeting, scheduled for October 2024, will seek input and recommendations from the committee on the process for informed consent, “new areas of focus” for informed consent, and recent policy on “key information.”

By Laura DiAngelo, MPH | Aug 27, 2024 6:36 PM CDT

Quick background: The FDA, HHS and informed consent

  • In the U.S., many types of clinical research must comply with regulations intended to protect the rights of research participants. Those protections are found at 21 CFR 50 and 56 and include concepts like informed consent, appropriate clinical trial oversight by institutional review boards (IRBs), the review of investigational research protocols by the FDA, and ensuring that test articles have been appropriately vetted prior to human use.
  • Informed consent is one of the three foundational protections for research involving human subjects. The requirement stems from ethical principles of respect for persons and autonomy, as first introduced in the landmark Belmont Report on research ethics. The three main aspects of informed consent to research participation include disclosing information needed for an informed decision; ensuring understanding of the disclosed information; and ensuring that the decision regarding participation is voluntary. “The informed consent process is the critical communication link between the prospective human subject and an investigator, beginning with the initial approach of an investigator to the potential subject […] and continuing until the completion of the research study,” according to a Department of Health and Human Services (HHS) FAQ on informed consent.
  • FDA and HHS have some overlapping authority in this area, but take similar approaches. While the FDA regulates the conduct of clinical trials which evaluate medical products, its parent department, HHS oversees the conduct of all studies that involve human subjects. HHS incorporated the recommendations from the Belmont Report into two sets of regulations: one that pertained broadly to all human subject research, and one that was specific to research involving children. Eventually, the broader regulations would become known as the Subpart A requirements, or the “ Common Rule” (45 CFR Part 46). Likewise, considerations for research involving special populations are captured in Subpart B (Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research), Subpart C (Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects), and Subpart D (Additional Protections for Children Involved as Subjects in Research) of the HHS regulations on human subject research.
  • However, HHS’ regulations only apply to research that is directly conducted or supported by the U.S. government, so FDA’s regulations are technically parallel to HHS’. As explained by the FDA previously, there are differences in scope, definitions of key terms such as “research” and “subject,” qualifying for exemptions from oversight, and more. Nonetheless, to make it easier for investigators and IRBs, and to prevent further regulatory overlap, the passage of the 21st Century Cures Act in 2016 included a new requirement that FDA must “harmonize with the Common Rule whenever permitted by law.” After some missed deadlines, the FDA published a proposed rule to harmonize its work with the Common Rule in September 2022.
  • The FDA revised its guidance on informed consent in 2023 – the first update to the document to be finalized since 1998. The new guidance offers recommendations and expectations for informed consent processes for Institutional Review Boards (IRBs), research program sponsors and researchers for regulated life sciences products. As AgencyIQ noted at the time, this was a significant overhaul of the guidance document, expanding even the 2014 draft version of the guidance document by an additional ~20 pages.
  • A new guidance on ‘key information’: In March 2024, FDA issued a new draft guidance document – issued jointly with HHS – on how research sponsors should consider the “key information” that participants need to know in informed consent. This included a recommendation that informed consent documents begin with an “introductory statement to frame the key information included in the consent form and to guide prospective subjects when reading the entire document.” This approach was intended to help contextualize the form and its information for potential study participants. That guidance has been met with strong support from industry (see, for example, comments submitted to the draft document’s docket by trade associations PhRMA and AdvaMed), while these stakeholders also continue to call for modernized and more flexible informed consent policy.

FDA’s Center for Devices and Radiological Health (CDRH) has announced a new meeting to discuss “patient-centered” informed consent

  • A quick intro: CDRH’s Patient Engagement Advisory Committee. The PEAC has a patient-focused roster, comprised of members representing patients, patient advocates, caregivers and representatives of patient advocacy organizations. PEAC’s role is unique among FDA advisory committees, in that the PEAC is convened to source areas of interest or concern from the end-users of medical devices, rather than with the goal of concrete regulatory/clinical/statistical input on the regulation of specific products/product types. Rather than resolving regulatory issues, the outcomes of these meetings tend to raise novel questions that regulators, and product developers, will need to consider or address downstream.
  • On October 30, 2024, CDRH will convene the PEAC to discuss “Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products.” According to the notice, the goal of this meeting is to seek recommendations from the PEAC on both “the informed consent process and the areas of focus of the informed consent.” Further, the PEAC members will “provide recommendations on factors to consider when communicating informed consent to clinical study participants to increase the likelihood of participants understanding the key elements of research.”
  • Notably, while PEAC is one of CDRH’s advisory committees, the notice itself does not specifically say that they will be discussing patient-centered informed consent for medical devices – instead it says “FDA-Regulated Medical Products.” This could indicate that the committee will be asked to weigh in on informed consent processes more broadly, with recommendations that would apply to drug and biological product sponsors as well.
  • This focus on “key elements” or “key information” (as described in the March 2024 guidance, see above) is likely to be a major point of discussion at the meeting. The meeting announcement specifically points to that guidance document as one of the actions FDA has taken to “improve informed consent over the years” and flags ongoing concerns that “informed consent forms are lengthy and difficult for potential research participants to understand.”
  • The feedback from PEAC could inform the final version of that guidance, in particular as the agency continues to focus on incorporating patient voice into its own policy-making processes. Further, the ways that the current informed consent process affect health equity – in effect, whether the “lengthy and difficult” forms are inappropriately disincentivizing research participation from historically under-represented and/or under-resourced groups, is likely to be of key concern for the PEAC. The balance between ensuring appropriate accessibility of the documents while still maintaining a high bar of safety for all participants will be a complex issue for discussion as well, and a challenge for the FDA’s policymaking.
  • What’s next? The meeting will be held October 30, 2024. The meeting does not have a docket for the submission of comments, but interested parties can request to make a presentation at the meeting.


To contact the author of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com).
To contact the editor of this item, please email Alexander Gaffney ( agaffney@agencyiq.com)

Key Documents and Dates

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By Scott Stephens, MPA

Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars and meetings.

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