What we expect European regulators to do in April 2024

What we expect to be talking about in April:

• April will see a significant increase in meetings, both from regulators and third-party organizations. This will include a number of conferences, webinars, and training sessions, as well as a long-awaited EMA workshop on psychedelics.
• Perhaps the most significant pharmaceutical news anticipated for April: the vote on the pharmaceutical legislation revision. With the ENVI vote in favor of the compromise completed in March, the path has been cleared for the upcoming European Parliament plenary. In late April, Parliament is also expected to vote on the Regulation of Substances of Human Origin (SOHO), which was approved by ENVI in February.
• Health technology assessment (HTA) implementing regulations may also take the stage in April. The Commission released the first HTA implementing regulation in March – for joint clinical assessments – which is open for public comment until April 2. A number of other HTA implementing regulations are also planned for Q2 2024.
• E.U. medical device regulators are expected to pass some notable legislative amendments, which would extend the compliance deadlines of the IVD Regulation by risk class, allow a phased roll-out of EUDAMED, and also require manufacturers to notify stakeholders of any interruptions in device supply. The original proposal is expected to pass without amendments. Also of note in April, the Commission is seeking public comment on its update to the benefit-risk assessment of phthalates in medical devices; comments close on April 28.

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).

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 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.

Guidelines effective in April

The following guidelines will come into effect during April 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.

Regulatory actions expected in April

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

Other deadlines occurring in April

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

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.

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