What we expect European regulators to do in May 2024

Life Sciences | By CHELSEY MCINTYRE, PHARMD, KIRSTEN MESSMER, PHD, RAC, COREY JASEPH, MS, RAC, KARI OAKES, SEBASTIAN GODOY, MPH

Apr. 30, 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, comment periods, and more. Given the expansive and complex European life sciences regulatory landscape, we’ll be including updates from key E.U. and national regulators. The goal: to allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts.

What we expect to be talking about in May:

  • Regulators, especially from the EMA and national competent authorities, will be busy with lots of meetings in May. Many of these are webinars and/or trainings sessionsfor new digital platforms. This month will also see several large, multi-day conferences hosted by public and private stakeholders.
  • The Critical Medicines Alliance met on April 24; we will watch for new recommendations coming from that discussion, with shortages and equitable access likely to be the key conversation topics. Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May.
  • The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U. voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Now the text is bound for the trilogue for a vote after Parliament’s election. In the interim, the European Council will continue to discuss the package, and stakeholders may gain some insight into the Council’s thinking near the end of May. Additionally, the Council will also be setting a vote to formally adopt the European Health Data Space and Substances of Human Origin regulation endorsed by Parliament on April 24.
  • Some big device deadlines are coming up, while some are deferred. Parliament voted on the extension to the diagnostic regulation (IVDR) compliance deadlines in plenary this week. The extension discussion and vote also allow for a phased rollout of the EUDAMED database and require manufacturers to report on critical device shortages. Given that this vote falls under the E.U.’s urgent procedure framework, stakeholders can look for these updates in the Official Journal soon. In more news, the April 30 deadline for the E.U.’s second informal call for more European Reference Laboratories for high-risk diagnostic devices is upon us. However, the big deadline is May 26, since all manufacturers intending to transition to the European medical device regulation (MDR) need to apply to Notified Bodies by that date.

Upcoming meetings

The following list encapsulates meetings expected for the months of April and May for various European bodies, including relevant 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
4/30/2024 4/30/2024 Seminar No. 20 – Medical Device Regulation Section/Department of Expert Activities/Department of Clinical Evaluation of Medical Devices Webinar/ Seminar (OPEN) Czech State Institute for Drug Control
4/30/2024 4/30/2024 BIVDA 2024 EDI Summit ‘Barriers to Inclusion’ Committee Meeting (CLOSED) British In Vitro Diagnostics Association (BIVDA)
5/02/2024 5/02/2024 MHRA Webinar on International Recognition – post-launch updates Webinar/ Seminar (OPEN) U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA)
5/02/2024 5/02/2024 Infectious Diseases Working Party Committee Meeting (CLOSED) British In Vitro Diagnostics Association (BIVDA)
5/02/2024 5/02/2024 Navigating Medical Device Cybersecurity Waters: Regulatory Similarities and Differences Between the EU and US Seminar/Conference (OPEN) MedCrypt/ Johner Institut
5/03/2024 5/04/2024 8th Rare Disease Symposium: “Rethinking Rare” Webinar/ Seminar (OPEN) Eva Luise and Horst Köhler Foundation
5/06/2024 5/08/2024 RAPS Euro Convergence Conference (OPEN) Regulatory Affairs Professional Society (RAPS)
5/06/2024 5/08/2024 Antimicrobial resistance (AMR) conference Conference (OPEN) European Centre for Disease Prevention and Control (ECDC) / Belgian Council Presidency
5/07/2024 5/07/2024 Information and Q&A session on updated Centrally Authorized Products in web-based eAF Webinar (OPEN) EMA
5/07/2024 5/07/2024 Psychedelics and their therapeutic use – Linkedin Live interview with Steffen Thirstrup, EMA’s Chief Medical Officer Webinar (OPEN) EMA
5/09/2024 5/09/2024 Near Patient Testing Working Party Committee Meeting (CLOSED) British In Vitro Diagnostics Association (BIVDA)
5/10/2023 5/10/2023 Clinical trial: BfArM meets…! Webinar/ Seminar (OPEN) BfArM
5/13/2024 5/13/2024 Medical Device Coordination Group Meeting Committee Meeting (CLOSED) Medical Device Coordination Group (MDCG)
5/13/2024 5/13/2024 Meeting between the Medical Device Coordination Group (MDCG) and Stakeholders Committee Meeting (CLOSED) Medical Device Coordination Group (MDCG)
5/13/2024 5/17/2024 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the E.U.: Hands-on training course Webinar/ Seminar (OPEN) EMA
5/14/2024 5/14/2024 From paper to digital leaflets: making patient information more inclusive Webinar/ Seminar (OPEN) Association of the European Self-Care Industry (AESGP)
5/14/2024 5/14/2024 Changes in the area of DiGA due to the Digital Act Webinar/ Seminar (OPEN Germany’s Federal Institute for Drugs and Medical Devices (BfArM)
5/14/2024 5/15/2024 Conference on Preparedness: Europe united against old and new pandemics Conference (OPEN) Belgian presidency of the Council of the EU
5/14/2024 5/15/2024 A Growing Convergence: RWE for Regulatory and HTA Decision-Making Conference (OPEN) GetReal Institute
5/15/2024 5/16/2024 European Conference on Rare Diseases & Orphan Products (ECRD 2024) Webinar/Seminar (OPEN) EURORDIS
5/16/2024 5/16/2024 Genomics Working Party Committee Meeting (CLOSED) British In Vitro Diagnostics Association (BIVDA)
5/17/2024 5/17/2024 External Affairs Working Party Webinar/ Seminar (OPEN) British In Vitro Diagnostics Association (BIVDA)
5/21/2024 5/21/2024 MHRA Board Meeting Committee Meeting (OPEN) U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA)
5/22/2024 5/22/2024 Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party Webinar (CLOSED) EMA
5/22/2024 5/24/2024 The MedTech Forum 2024 Conference (OPEN) MedTech Europe
5/24/2024 5/24/2024 Follow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma Webinar (OPEN) EMA/ European Organization of Research and Treatment of Cancer (EORTC)
5/27/2024 5/30/2024 CHMP Committee Meetings Committee Meeting (CLOSED) EMA
5/27/2024 5/27/2024 Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system Webinar/ Seminar (OPEN) EMA
5/28/2024 5/28/2024 Regulatory affairs forum Conference (OPEN) Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel) / CTC Resourcing Solutions
5/28/2024 5/29/2024 The convergence of technologies enabling R&I for the healthcare of the future Conference (CLOSED) Belgium Presidency Council of the EU
5/29/2024 5/29/2024 Discussion event on clinical drug trials Webinar/ Seminar (OPEN) Finnish Medicines Agency (FIMEA)
5/31/2024 5/31/2024 IMI impact on antimicrobial resistance Webinar Innovative Health Initiative (IHI)
05/29/2024 05/29/2024 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products Webinar (CLOSED) EMA
5/29/2024 5/31/2024 Evidence Based Early Diagnosis Conference 2024 Conference (OPEN) University of St. Andrews, Oxford, the British Medical Journal

 

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).

 

Anticipated
EC Decision
Drug Company CHMP Opinion
May 2024 Fabhalta
(Iptacopan)
Novartis Positive
May 2024

Awiqli

(insulin icodec)

Novo Nordisk Positive
May 2024

Lytenava

(bevacizumab)

Outlook Therapeutics Positive
May 2024

Jubbonti*

(denosumab)

Sandoz Positive
May 2024

Omlyclo*

(omalizumab)

Celltrion Healthcare Positive
May 2024 Wyost*
(denosumab)
Sandoz Positive
May 2024 Agilus
(dantrolene sodium, hemiheptahydrate)
Norgine Positive
May 2024 Neoatricon
(dopamine)
BrePco Biopharma Positive
May 2024 Dimethyl fumarate Accord**
(dimethyl fumarate)
Accord Healthcare Positive
May 2024 Dimethyl fumarate Mylan**
(dimethyl fumarate)
Mylan Positive
May 2024

Dimethyl fumarate Neuraxpharm**

(dimethyl fumarate)

Neuraxpharm Pharmaceuticals Positive
June 2024

Altuvoct

(efanesoctocog alfa)

Swedish Orphan Biovitrum AB Positive
June 2024

Fruzaqla

(fruquintinib)

Takeda Pharmaceuticals International AG Ireland Branch Positive
June 2024

Jeraygo

(aprocitentan)

Idorsia Pharmaceuticals Deutschland Gmb Positive
June 2024

Obgemsa

(vibegron)

Pierre Fabre Medicament Positive
June 2024

Truqap

(capivasertib)

AstraZeneca AB Positive
June 2024

Tofidence*

(tocilizumab)

Biogen Netherlands B.V. Positive
June 2024

Wezenla*

(ustekinumab)

Amgen Technology (Ireland) UC Positive
June 2024

Eribulin Baxter**

(eribulin)

Baxter Holding B.V. Positive

*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 Q2 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
Development and manufacture of synthetic peptides [EMA] Scientific guideline 4/30/2024
Draft guideline on the clinical requirements for non replacement therapy in hemophilia A and B [EMA] Scientific guideline

4/30/2024

Guideline on the clinical evaluation of medicinal products intended for treatment of hepatitis B [EMA] Scientific guideline

4/30/2024

Concept paper for the development of a reflection paper on a tailored clinical approach in biosimilar development [EMA] Concept paper 4/30/2024
Concept paper on the development of a guideline on the non-clinical and clinical evaluation of antiviral medicinal products and monoclonal antibodies for the prevention and treatment of COVID-19 [EMA] Concept paper 4/30/2024
Product-specific bioequivalence guidance on paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg [EMA] Product-specific bioequivalence guidance 4/30/2024
Product-specific bioequivalence guidance on azacitidine powder for suspension for injection 25 mg/ml [EMA] Product-specific bioequivalence guidance 4/30/2024
Medical Device Software: Considerations for Device and Risk Characterization [IMDRF] Standard document 5/02/2024
Concept Paper for the Development of a Guideline on Non-Inferiority and Equivalence Comparisons in Clinical Trials [EMA] Concept paper 5/31/2024
Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations [EMA] Scientific guideline 5/31/2024
Draft guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials – Second version [EMA] Scientific guideline 5/31/2024
Draft revised HMA/EMA guidance on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier [EMA] Guideline 6/28/2024
Product-specific bioequivalence guidance on dabrafenib hard capsule 50 and 75 mg [EMA] Product-specific bioequivalence guidance 6/30/2024
Product-specific bioequivalence guidance on trametinib film-coated tablet 0.5 and 2 mg [EMA] Product-specific bioequivalence guidance 6/30/2024
Pharmeuropa 36.2 [European Pharmacopeia] Draft monographs 6/30/2024

 

Guidelines effective in May

The following guidelines will come into effect during May 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

 

Regulatory actions expected in May

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

 

Expected Action Description of action Date
AI-Airlock (a U.K. MHRA sandbox) projected to launch AI-Airlock End of April 2024
MDR DEADLINE: All manufacturers intending to transition devices to the MDR must apply to a designated Notified Body, in order to make use of the extended transition times under Regulation (EU) 2023/607 Application deadline 5/26/2024

 

Other deadlines occurring in May

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

 

Program Agency Deadline
Call for informal expressions of interest: EU Reference Laboratories European Commission 4/30/2024
Survey: Strategy for Ph. Eur. quality standards for monoclonal antibodies: monographs and horizontal standards European Pharmacopoeia Commission (EPC) 4/30/2024
Call for applicants: International 3Rs prize NC3Rs 5/01/2024
Call for tenders: Intelligence gathering on priority threats and medical countermeasures European Health and Digital Executive Agency (HaDEA) 5/15/2024
Call for proposals: Topics include heart disease, the healthcare workforce and biomarkers Innovative Health Initiative (IHI) 5/22/2024

 

Pending E.U. 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 E.U.’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 Parliament endorsed, texts head to the trilogue following the parliament elections in June
Health technology assessment – joint clinical assessments of medicinal products Implementing regulation Anticipated for Q1 2024; consultation on draft closing on April 2
Regulation of Substances of Human Origin (SoHO) Implementing regulation Parliament endorsed, European Council to vote ahead of Parliament’s June elections
European Health Data Space Implementing regulation

Parliament endorsed, European Council to vote ahead of Parliament’s June elections

Proposal to extend the compliance dates of the IVD Regulation, allow a phased roll-out of EUDAMED, and require notifications of device supply interruptions Amending regulation Parliament voted favorably under urgent procedure mechanism in the April 22-25 session
Performance of pharmacovigilance activities for human medicines (update of Implementing Regulation (EU) 520/2012) Implementing regulation Anticipated for Q2 2024
Health technology assessment – procedural rules for assessing and managing conflicts of interest Implementing regulation Anticipated for Q2 2024
Report on the General Data Protection Regulation Report Anticipated for Q2 2024
Review of the Health Emergency Preparedness and Response Authority (HERA) Report Anticipated for Q2 2024
Health technology assessment – cooperation with the EMA Implementing regulation Anticipated 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 scientific consultations on medicinal products for human use Implementing regulation Anticipated for Q2 2024
Health technology assessment – joint clinical assessments of medical devices Implementing regulation Anticipated for Q3 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

 

To contact the authors of this resource, please email Sebastian Godoy ( [email protected]).

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