What we expect European regulators to do in December 2023

EMA Today | By SIERRA MILAM, CHELSEY MCINTYRE, PHARMD, KARI OAKES, KIRSTEN MESSMER, PHD, RAC, COREY JASEPH, MS, RAC

Nov. 28, 2023

In this new 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 December:

  • The EMA will relaunch its website on Tuesday, December 5 with a “ fresh look and feel.” The new site will feature an updated medicines search, new navigation tools, and a revamped What’s new page. According to the agency’s announcement, all existing links will continue to work after the relaunch.
  • Many regulatory authorities will close at the end of December. The E.U. recognizes December 24-29 as the end-of-year holidays. The EMA will be closed from December 23 to January 2 and has published a notification on its operations related to this closure.
  • The changes to the EMA’s Fee Regulation (Regulation (EC) No 297/95) could be adopted during this month’s planned plenary meeting. The European Parliament is set to vote during the plenary meeting on December 12. If all changes are accepted, the date of application is set to be January 1, 2025.
  • ENVI also hopes to reach an agreement on changes to the regulation of Substances of Human Origin (SoHOs) before the holiday period. However, no timeline is available for legislative actions in the new year.
  • We are expecting to see the release of an E.U. critical medicines list and the launch of a preparatory study to further assess the functionality and impact of the potential “Critical Medicines Act.” The European Commission also plans to create a Critical Medicines Alliance for a more coordinated effort in managing drug shortages within the E.U. This effort will most likely be set up in early Q1 of 2024.

This December look-ahead includes all activities that we anticipate will occur through January 1, 2024. With the winter holidays approaching, stakeholders will likely need to address any relevant deadlines or legislative actions prior to January 1.

Upcoming E.U. meetings

We have provided the following list that encapsulates the expected meetings for the month of December 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
12/01/2023 12/01/2023 BIVDA Environmental Working Party Webinar/Seminar (CLOSED) British In Vitro Diagnostics Association (BIVDA)
12/04/2023 12/04/2023 HMA/EMA Big Data Stakeholder Forum 2023 Webinar/Seminar (OPEN) European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA)
12/04/2023 12/04/2023 ENVI Committee Meeting Committee Meeting (OPEN) European Parliament committee on the environment, public health, and food safety (ENVI)
12/04/2023 12/07/2023 Cell & Gene Therapy Manufacturing & Commercialization Europe Conference (OPEN) European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
12/05/2023 12/05/2023 IT tools for regulatory science: aggregating available data for assisting Expert Panels and improving post-market surveillance Webinar/ Seminar (OPEN) Coordinating Research and Evidence for Medical Devices (CORE-MD)
12/05/2023 12/07/2023 DIA Global Clinical Trial Disclosure and Data Transparency Conference (OPEN) Drug Information Association, Inc (DIA)
12/07/2023 12/07/2023 European Health Summit 2023 Conference (OPEN) European Business Summits
12/07/2023 12/07/2023 Methodology Working Party stakeholder interaction meeting Webinar/Seminar (OPEN) European Medicines Agency (EMA)
12/07/2023 12/07/2023

Seminar No. 14 – Obligations of distributors and importers of medical devices

Webinar/Seminar (OPEN)

Czech National Information System for Medical Devices (NISZP)
12/11/2023 12/14/2023 Parliament Plenary Meeting Committee Meeting (OPEN) European Parliament
12/11/2023 12/14/2023 CHMP Committee Meeting

Committee Meeting (CLOSED)

Committee for Medicinal Products for Human Use (CHMP)
12/11/2023 12/14/2023 Clinical Trials Information System (CTIS) sponsor end user training programme – December 2023

Webinar/Seminar (OPEN)

European Medicines Agency (EMA)

12/12/2023 12/12/2023 What’s in the pipeline of the European Pharmacopoeia Commission

Webinar/Seminar (OPEN)

Finnish Medicines Agency (FIMEA)
12/13/2023 12/14/2023 Horizon Scanning Event Webinar/ Seminar (OPEN)

Finnish Medicines Agency (FIMEA)

12/13/2023 12/13/2023 7th Biosimilar medicines multistakeholder event Seminar (OPEN) European Commission
12/14/2023 12/14/2023 Seminar for Distributors of Medical Devices and Technology Specialists of Medical Institutions Webinar/ Seminar (OPEN) State Medicines Agency of Latvia (ZVA)
12/14/2023 12/14/2023 MDR Technical Documentation Training for Manufacturers Webinar/Seminar (OPEN) Team-NB
12/14/2023 12/14/2023 Webinar on the new Ph. Eur. Cannabis Flower Monograph Webinar/ Seminar (OPEN) European Directorate for the Quality of Medicines & HealthCare
12/14/2023 12/14/2023 Providing high-risk medical devices for children – insights and proposals

Webinar/ Seminar (OPEN)

Coordinating Research and Evidence for Medical Devices (CORE-MD)

12/15/2023 12/15/2023 BIVDA Regulatory Affairs Working Party Webinar/Seminar (CLOSED) British In Vitro Diagnostics Association (BIVDA)
12/18/2023 12/18/2023 AI in Swedish Healthcare

Webinar/Seminar (OPEN)

Swedish Medical Products Agency
12/19/2023 12/19/2023 EMA Quarterly System Demo

Webinar/Seminar (OPEN)

European Medicines Agency (EMA)

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
December 2023 Rezzayo
(rezafungin)
Mundipharma GmbH Positive
December 2023 Elrexfio
(elranatamab)
Pfizer Positive
December 2023 Loargys
(pegzilarginase)
Immedica Pharma Positive
December 2023 Agamree
(Vamorolone)
Santhera Pharmaceuticals Positive
December 2023 Elucirem
(Gadopiclenol)
Guerbet Positive
December 2023 Vueway
(Gadopiclenol)
Bracco Imaging Positive
December 2023 Veoza
(fezolinetant)
Astellas Pharma Positive
January 2023 Rimmyrah
(ranibizumab)*
Qilu Pharma Spain Positive
January 2023 Spexotras
(trametinib)
Novartis Europharm Positive
January 2023 Rystiggo
(rozanolixizumab)
UCB Pharma Positive
January 2023 Omjjara
(momelotinib)
GlaxoSmithKline Positive
January 2023 Uzpruvo
(ustekinumab)*
Stada Arzneimittel AG Positive
January 2023 Naveruclif
(paclitaxel)**
Accord Healthcare S.L.U. Positive
January 2023 Azacitidine Kabi
(azacitidine)**
Fresenius Kabi Deutschland GmbH Positive
January 2023 Krazati
(adagrasib)
Mirati Therapeutics B.V. Positive

*Biosimilar
**Generic

Notable comment periods closing in December

Below are various deadlines regarding E.U. policy, such as public registers, drafts, reflection papers, concept papers and guidance documents expected to close in December. 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.

Title Type Comments Close
Executive orders on fees for clinical trials with medicinal products [Denmark] Draft Notice 12/08/2023
Criteria for sustainable purchasing of medical imaging equipment [COCIR] Harmonized sustainability criteria 12/15/2023
Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle [EMA] Reflection paper

12/31/2023

Revisions for Pharmeuropa 35.4 (34 chapters) [European Pharmacopoeia] Chapter revisions 12/31/2023
Concept paper on the development of an addendum to the Guideline on clinical development of vaccines on clinical trials for vaccines for immunocompromised individuals [EMA] Concept paper 01/01/2024

Forecasted comment periods and adoption dates

Below are various deadlines regarding E.U. policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected into Q1 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 or linger after planned adoption dates.

Title Call for Evidence Closes Comments Close Planned Adoption
Draft E.U. herbal monograph on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix – Revision 2 N/A 01/15/2024 N/A
Concept Paper on the revision of the scientific guideline on influenza vaccines – non-clinical and clinical module N/A 01/30/2024 N/A
Draft guideline on the clinical requirements for non replacement therapy in haemophilia A and B N/A 01/30/2024 N/A
Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders – Revision 3 N/A 01/30/2024 N/A

Implementation strategy of ICH Guideline M10 on

bioanalytical method validation

N/A 01/31/2024 N/A
Review of the Health Emergency Preparedness and Response Authority (HERA) N/A 02/19/2024 N/A
Concept paper on the revision of the Guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches N/A 02/28/2024 N/A
Health technology assessment – procedural rules for assessing and managing conflicts of interest N/A TBD Q1 2024
Guideline on clinical investigation of medicinal products in the treatment of depression N/A

03/31/2024

N/A

Regulatory actions expected in December

This list, based on AgencyIQ analysis, contains a variety of regulatory happenings that are expected to occur in December across the E.U.

Expected Action Description of action Date
Eudamed Module: Market Surveillance [E.U.] Completed development of the EUDAMED Market Surveillance module Q4 2023
Designation of E.U. Reference Laboratories Proposal for five laboratories to receive E.U. Reference Laboratory designation Q4 2023
Critical medicines list [E.U.] Development of a union list of critical medicines (medicines with no appropriate alternative for which a shortage would result in serious harm or risk of harm) 12/31/2023

MHRA international recognition framework for medicines

[U.K.]

The International Recognition Procedure (IRP) officially replaces the EC Decision Reliance Procedure (EDRP) in the U.K. 01/01/2024
Executive orders on fees for clinical trials with medicinal products [Denmark] Updated fees for clinical trials from the Danish Ministry of the Interior and Health 01/01/2024

Regulatory actions that are overdue as of December

The following regulatory actions have missed their original proposed deadlines and remain pending with no updated deadlines provided at this time.

Expected Action Description of action Original Deadline
Pharmaceuticals – changes to marketing authorisations (review of EU rules) [E.U.] Although commission adoption was planned for Q4 2023, the call for evidence closed in 09/2023 and no further action has been taken Q4 2023
Health technology assessment – Joint clinical assessments of medicinal products [E.U.] The feedback period was set to open in Q4 2023; however, no action has yet been taken. Q4 2023
Performance of pharmacovigilance activities for human medicines (update of Implementing Regulation (EU) 520/2012) [E.U.] A targeted amendment to Regulation (EU) No 520/2012 to harmonize the performance of pharmacovigilance activities; no action has yet been taken. Q2 2022

E.U. guidelines effective at the beginning of 2024

The following guidelines will come into effect on January 1, 2024, 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.

Regulation Link Description of the Guideline Action Planned
Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus

Addresses the E.U.’s regulatory position on the clinical development of new medicinal products for the treatment or prevention of diabetes types 1 and 2

01/01/2024
Paracetamol oral use immediate release formulations product-specific bioequivalence guidance Provides updated product-specific bioequivalence guidance for oral immediate release formulations of paracetamol 01/01/2024
Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance Provides updated product-specific bioequivalence guidance for tadalafil film-coated tablets 01/01/2024
Ibuprofen oral use immediate release formulations 200– 800 mg product-specific bioequivalence guidance Provides updated product-specific bioequivalence guidance for oral immediate release formulations of ibuprofen 01/01/2024

Deadlines occurring in December

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

Program Agency Deadline
Call for volunteers to offer experiences of racial bias in healthcare due to pulse oximeters U.K. Medicines and Healthcare products Regulatory Agency (MHRA) 12/05/2023
Call for expression of interest: Independent scientific experts to participate in the Pharmacovigilance Risk Assessment Committee (PRAC) European Medicines Agency (EMA) 12/07/2023
Call for expressions of interest: Representatives of patients’ organisations for the Committee for Orphan Medicinal Products (COMP) European Medicines Agency (EMA) 12/07/2023
Early Cancer Diagnosis Clinical Validation and Evaluation Call National Institute for Health and Care Research (NIHR) / Office for Life Sciences (OHS) 12/12/2023
Call for independent experts for the Advisory Committee on Public Health Emergencies (PHE) European Commission 12/15/2023
Device guidance documents due in 2023 – 27 documents due or overdue for 2023 that are not yet complete Medical Device Coordination Group (MDCG) 12/31/2023

To contact the authors of this resource, please email Sierra Milam ( [email protected]) or Chelsey McIntyre ( [email protected]).

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