What we expect European regulators to do in November 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.
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: 11/9/2025: |
To contact the authors of this resource, please email Sierra Milam ( smilam@agencyiq.com).
To contact the editor of this resource, please email Chelsey McIntyre ( cmcintyre@agencyiq.com).