What we expect European regulators to do in July 2024

What we expect to be talking about in July

• Regulators of all sizes – from the EMA to national competent authorities – will be busy managing a variety of meetings and trainings. Several webinars and training sessions are geared towards ISO identification of medicinal products (IDMP) standards which is referred to as Substance, Product, Organization, Referentials (SPOR) data management services. There will also be a rescheduled webinar held at the end of the month to go over the Artificial Intelligence Airlock initiative spearheaded by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA).
• The European Council held its first public debate of the proposed pharmaceutical legislation last week. Just as a quick reminder, the European Commission and European Parliament locked their positions in. Now it is up to the Council to provide their position. The outgoing Belgian Presidency further complicated discussions in the “incentives cluster” by suggesting four options that aim to ensure market access. Some “add-on” regulatory data protection may also be converted to market exclusivity. However, this was the first public debate and Hungary will take over the Presidency next week. With E.U. elections over, AgencyIQ is also anticipating the new European Parliament to start work again soon.
• Device regulators have dropped important guidance recently, publishing guidance on alternative trial designs for orphan devices and updating how to carry out benefit-risk assessments on the use of toxic phthalates in medical devices. We also saw a device-specific vigilance guidance published on surgical mesh. A new standardization request would push back updates and harmonization of the standards needed for MDR and IVDR another four years. Coming up is publication of the amendments to the IVDR and MDR, that would postpone the final IVDR compliance date for diagnostics that qualify for the extension, allow for a phased rollout of EUDAMED and would require manufacturers of certain devices to notify regulators and clients of upcoming shortages.

Upcoming meetings

The following list encapsulates meetings expected for the month of July for various European bodies, including relevant committees. The information below includes the event type and whether the meeting can be attended by the public (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 Q3 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 July

The following guidelines will come into effect during July 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 July

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

Other deadlines occurring in July

This list incorporates various deadlines that AgencyIQ is aware are occurring during July. 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 E.U. 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).