What we expect European regulators to do in December 2023

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).

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).

*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.

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.

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.

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.

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.

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.

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