What we expect European regulators to do in May 2024

What we expect to be talking about in May:

• Regulators, especially from the EMA and national competent authorities, will be busy with lots of meetings in May. Many of these are webinars and/or trainings sessionsfor new digital platforms. This month will also see several large, multi-day conferences hosted by public and private stakeholders.
• The Critical Medicines Alliance met on April 24; we will watch for new recommendations coming from that discussion, with shortages and equitable access likely to be the key conversation topics. Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May.
• The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U. voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Now the text is bound for the trilogue for a vote after Parliament’s election. In the interim, the European Council will continue to discuss the package, and stakeholders may gain some insight into the Council’s thinking near the end of May. Additionally, the Council will also be setting a vote to formally adopt the European Health Data Space and Substances of Human Origin regulation endorsed by Parliament on April 24.
• Some big device deadlines are coming up, while some are deferred. Parliament voted on the extension to the diagnostic regulation (IVDR) compliance deadlines in plenary this week. The extension discussion and vote also allow for a phased rollout of the EUDAMED database and require manufacturers to report on critical device shortages. Given that this vote falls under the E.U.’s urgent procedure framework, stakeholders can look for these updates in the Official Journal soon. In more news, the April 30 deadline for the E.U.’s second informal call for more European Reference Laboratories for high-risk diagnostic devices is upon us. However, the big deadline is May 26, since all manufacturers intending to transition to the European medical device regulation (MDR) need to apply to Notified Bodies by that date.

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 May

The following guidelines will come into effect during May 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 May

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

Other deadlines occurring in May

This list incorporates various deadlines that AgencyIQ is aware are occurring during May. 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 Sebastian Godoy ( sgodoy@agencyiq.com).