What we expect European regulators to do in November 2023

Life Sciences | By SIERRA MILAM, KARI OAKES, KIRSTEN MESSMER, PHD, RAC, COREY JASEPH, MS, RAC

Oct. 25, 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 November:

  • The proposed revised pharmaceutical directive and regulation: On November 7, the European Parliament Committee on the environment, public, health and food safety (ENVI) will be meeting to negotiate a stance on the legislation, a discussion that will be broadcast live. This discussion will play an integral role in future access to medicines, as both proposals are looking to update and amend procedures for supervising and authorizing medicinal products within the E.U.
  • A wide range of other meetings that will be occurring this month, with various webinars, committee meetings, and workshops spanning a variety of topics. Many of these are open to any interested listener.

Upcoming E.U. Meetings

We have provided the following list of expected meetings for the month of November 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
11/2/2023 11/2/2023 European Device Regulations and In-house Devices Webinar/Seminar (OPEN) Czech Republic State Institute for Drug Control (SÚKL)
11/2/2023 11/2/2023 Ask The Expert: IVDR – Early Experience and Feedback

Webinar/Seminar (OPEN)

Criterion Edge
11/3/2023 11/3/2023 Medical Device Development and Market Strategy: Europe or US First? Or Both? Upcoming Webinar Hosted by Xtalks

Webinar/Seminar (OPEN)

Xtalks
11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes? Webinar/ Seminar (OPEN) Coordinating Research and Evidence for Medical Devices (CORE-MD)
11/6/2023 11/7/2023 ENVI Committee Meetings in 2023 Committee Meeting (OPEN)

European Parliament committee on the environment, public health and food safety (ENVI)

11/6/2023 11/8/2023 6th European Training Course on Quality Management for Blood Establishments Training Program (OPEN)

European Directorate for the

Quality of Medicines & HealthCare (EDQM)

11/6/2023 11/9/2023 CHMP Meetings 2023 Committee Meeting (CLOSED) EMA Committee for Medicinal Products for Human Use (CHMP)

11/7/2023

11/7/2023

ENVI Debate for Parliaments Negotiation Position – Revised Pharmaceutical Directive and Regulation

Committee Meeting (OPEN)

European Parliament committee on the environment, public health and food safety (ENVI)
11/7/2023 11/7/2023 Functional Capacity Studies for Companion Diagnostic IVDs Webinar/ Seminar (OPEN) Czech Medical Device National Information System (NISZP)
11/7/2023 11/7/2023 BASG Conversation: Pharmacovigilance Update2023 Webinar/Seminar (OPEN) BASG – Federal Office for Safety in Health Care under AGES MEA – Austrian Medicines and Medical Devices Agency
11/7/2023 11/7/2023 Medical Device Coordination Group – Annex XVI working group meeting Working Group Meeting (CLOSED) European Commission Medical Device Coordination Group (MDCG)
11/8/2023 11/8/2023 Medical Device Coordination Group – Market Surveillance working group meeting Working Group Meeting (CLOSED) European Commission Medical Device Coordination Group (MDCG)
11/8/2023 11/9/2023 Medical Device Coordination Group – Clinical Investigation and Evaluation working group meeting Working Group Meeting (CLOSED) European Commission Medical Device Coordination Group (MDCG)
11/9/2023 11/10/2023 EU Batch Release for Human Vaccines: A practical overview for newcomers to the system Webinar/ Seminar (OPEN) European Directorate for the Quality of Medicines & HealthCare (EDQM)
11/10/2023 11/10/2023 Infarmed and Advanced Therapy Medicines: From innovation to patients

Webinar/ Seminar (OPEN)

Infarmed (Portugal)
11/14/2023 11/14/2023 BIVDA Market Intelligence Group Webinar/ Seminar (Members Only) British In Vitro Diagnostics Association (BIVDA)
11/14/2023 11/14/2023 BASG discussion: Good laboratory practice Webinar/ Seminar (OPEN) BASG – Federal Office for Safety in Health Care under AGES MEA – Austrian Medicines and Medical Devices Agency
11/14/2023 11/14/2023 Unlocking access to biosimilars in Europe: what’s the way forward? Webinar/Seminar (OPEN) Sandoz/POLITICO Europe
11/14/2023 11/14/2023 EU Drug Precursors Regulatory Framework Workshop Workshop (OPEN) European Commission/Polish Chief Pharmaceutical Inspectorate
11/14/2023 11/15/2023 Patients’ and Consumers’ (PCWP) and Healthcare Professionals’ (HCPWP) Working Parties meeting with all eligible organisations Workshop (CLOSED) European Medicines Agency (EMA)
11/15/2023 11/16/2023 Products In Compliance Workshop (OPEN) RINA/COCIR
11/16/2023 11/16/2023 Policy Pulse Conference Conference
(OPEN)
MedTech Europe
11/16/2023 11/16/2023 EUCOPE’s Life Science Lectures – Episode Four Webinar/Seminar (OPEN) European Confederation of Pharmaceutical Entrepreneurs AISBL (EUCOPE)
11/16/2023 11/16/2023 Embracing the In Vitro Diagnostics Regulation: Achieving compliance excellence

Webinar/Seminar (OPEN)

Notified Body TÜV SÜD
11/17/2023 11/17/2023 BIVDA External Affairs Working Party Webinar/ Seminar (CLOSED) British In Vitro Diagnostics Association (BIVDA)
11/17/2023 11/17/2023 Workshop on generating clinical evidence for treatment and prevention options for long-COVID and post-acute sequelae condition (PASC) Webinar/Seminar (OPEN) European Medicines Agency (EMA)
11/20/2023 11/20/2023 BASG discussion: Quality deficiency management of medicinal products – introduction & update 2023 Webinar/ Seminar (OPEN) BASG – Federal Office for Safety in Health Care under AGES MEA – Austrian Medicines and Medical Devices Agency
11/20/2023 11/21/2023 AI workshop – Smart regulation in a rapidly evolving world Workshop
(OPEN)
Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA)
11/21/2023 11/21/2023 EU-Innovation Network Conference: Strengthening life-sciences innovation across Europe Webinar/ Seminar (OPEN) Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA)/Health Products Regulatory Authority (HPRA)
11/21/2023 11/21/2023 Lecture on the “Interchangeability of medicines”

Webinar/ Seminar (OPEN)

Croatian Agency for Medicinal Products and Medical Devices (Halmed)
11/22/2023 11/22/2023 BIVDA Infectious Diseases Working Party Webinar/ Seminar (CLOSED) British In Vitro Diagnostics Association (BIVDA)
11/22/2023 11/22/2023 Medical Device Use By Health Service Providers Webinar/ Seminar (OPEN) Czech Medical Device National Information System (NISZP)
11/23/2023 11/23/2023 Advertising Medical Devices and IVDs Webinar/ Seminar (OPEN) Czech Medical Device National Information System (NISZP)
11/23/2023 11/23/2023 ATC EU PA08 multi-stakeholder methodology workshop Workshop (CLOSED) European Medicines Agency (EMA)
11/24/2023 11/24/2023 Organisation Management System (OMS) Trouble Shooting Session for CTIS users

Webinar/Seminar (OPEN)

European Medicines Agency (EMA)
11/24/2023 11/24/2023 BIVDA Genomics Working Party Webinar/Seminar (CLOSED) British In Vitro Diagnostics Association (BIVDA)
11/24/2023 11/24/2023 Awareness Session for SMEs on the reform of the EU pharmaceutical legislation

Webinar/Seminar (OPEN)

European Federation of Pharmaceutical Industries and Associations (EFPIA)
11/27/2023 11/27/2023 International standards for clinical investigations of high-risk medical devices – the CORE-MD analysis with recommendations to regulators Webinar/ Seminar (OPEN) Coordinating Research and Evidence for Medical Devices (CORE-MD)
11/27/2023 11/30/2023 PRAC Meetings 2023 Committee Meeting (CLOSED) Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA)
11/27/2023 11/30/2023 SAWP 2023 Meetings Committee Meeting (CLOSED) Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA)
11/28/2023 11/28/2023 UKCA Sub-Group Webinar/Seminar (Members Only) British In Vitro Diagnostics Association (BIVDA)
11/28/2023 11/28/2023 Medical Device Coordination Group – Borderline and classification working group Working Group Meeting (CLOSED) European Commission Medical Device Coordination Group (MDCG)
11/28/2023 11/29/2023 DIA Innovating Clinical Trials in Europe Webinar/Seminar (OPEN) Drug Information Association, Inc (DIA)
11/29/2023 11/30/2023 ENVI Committee Meetings in 2023 Committee Meeting (OPEN) European Parliament committee on the environment, public health and food safety (ENVI)
11/30/2023 11/30/2023 BIVDA Procurement Working Party Webinar/Seminar (CLOSED) British In Vitro Diagnostics Association (BIVDA)
11/30/2023 11/30/2023 “The Product is the Process – Is it?” Manufacturing and Translation of ATMPs and Tissue – & Cell-based products Webinar/ Seminar (OPEN) Paul-Ehrlich-Institut – Federal Institute for Vaccines and Biomedicines

Notable Comment Periods Closing in November

Below are various deadlines regarding E.U. policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close in November. 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
Revision of the EU General Pharmaceuticals Legislation – Proposal for a Directive Pharmaceutical Package Proposal 11/8/2023
Revision of the EU General Pharmaceuticals Legislation – Proposal for a Regulation Pharmaceutical Package Proposal 11/8/2023
Concept paper on the development of a Reflection Paper on modern manufacturing techniques used for herbal preparations Concept Paper 11/15/2023

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 through 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
The European Pharmacopoeia (Ph. Eur.) revised general chapter Flow cytometry (2.7.24) N/A 12/31/2023 N/A
Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle N/A 12/31/2023 N/A
Pharmaceuticals – changes to marketing authorisations (review of EU rules) N/A N/A Q4 2023
Health technology assessment – joint clinical assessments of medicinal products N/A N/A Q4 2023
Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus N/A N/A 01/1/2024
Paracetamol oral use immediate release formulations product-specific bioequivalence guidance N/A N/A 01/1/2024
Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance N/A N/A 01/1/2024
Ibuprofen oral use immediate release formulations 200– 800 mg product-specific bioequivalence guidance N/A N/A 01/1/2024
Health technology assessment – procedural rules for assessing and managing conflicts of interest   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 November

This list, based on AgencyIQ analysis, can contain a variety of regulatory happenings across the E.U.

Expected Action Description of action Action
Revisions to the Swiss Device (MedDO) and IVD (IvDO) Regulations Regulations have been updated to take into account the extended transition period for medical devices in Europe and products with no intended medical purpose (Annex XVI of the European MDR) 11/1/2023:
Enters into force

Master Unique Device Identification (UDI) for contact lenses (Commission Delegated Regulation (EU) 2023/2197)

Regulation 2023/2197 was published in the Official Journal of the European Union (OJEU) on October 20.

11/9/2023:
Enters into force

11/9/2025:
Date of application

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

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