EU enlargement

The European Medicines Agency (EMA) takes part in projects to foster links with European Union (EU) enlargement countries, to lay the foundations of future co-operation in EMA's networks.

EMA's projects in the area of EU enlargement fall within the assistance programmes launched by the European Commission to support pre-accession activities for countries wishing to join the EU. 

Countries with the membership status of candidates are:

• Albania
• Bosnia and Herzegovina
• Georgia
• Moldova
• Montenegro
• North Macedonia
• Serbia
• Türkiye
• Ukraine

Additionally, Kosovo is a potential candidate.

Instrument for Pre-accession Assistance

The European Commission's Instrument for Pre-accession Assistance (IPA) programme supports the participation of enlargement countries in the work of selected EU agencies.

EMA activities under the IPA programme aim to build working relationships with the beneficiary national competent authorities, to prepare for their future collaboration in the European medicines regulatory network.

To achieve this aim, the programme offers assistance to beneficiary national competent authorities in aligning their standards and practices with those established in the EU and contributes to the creation of communication and information exchange systems that enable their effective participation in the networks of the EU regulatory system.

Programme activities include the below:

• Organising ad hoc conferences and training sessions to exchange views, explain the EU legal framework and identify areas for action
• Assisting beneficiary countries with participating in EMA meetings and training courses as observers
• Providing beneficiary countries with access to selected e-learning modules in the EU Network Training Centre (EU NTC)

For more details on the IPA programme, see European Commission: Overview - Instrument for Pre-accession Assistance.

EMA's participation in the IPA programme for 2024-26

EMA and the European medicines regulatory network continue to cooperate with beneficiary countries through a set of activities established in the project ‘EU4 alignment on medicines regulation in the Western Balkans and Türkiye’.

Current beneficiaries include:

• Albania
• Bosnia and Herzegovina
• Kosovo
• Montenegro
• North Macedonia
• Serbia
• Türkiye

Kosovo's designation as a current beneficiary is without prejudice to positions on status and is in line with UNSCR 1244 and the ICJ Opinion on the Kosovo Declaration of Independence.

Moldova, Georgia and Ukraine also take part of the program initiatives

Planned activities for beneficiaries include:

• Advanced trainings
• Expanded access to EMA's digital training catalogue
• Participation as observers in selected EMA working groups and parties:
  • Medicine Shortages Single Point of Contact (SPOC) Working Party
  • Good Manufacturing Practice (GMP)/Distribution Practice Practice (GDP) Inspectors Working Group
  • Good Clinical Practice Inspectors Working Group
  • Pharmacovigilance Inspectors Working Group
  • Environmental Risk Assessment Working Party
  • Immunologicals Working Party
  • Antimicrobials Working Party
  • European sales and use of antimicrobials for veterinary medicines Working Group (EASUAvet WG)

The European Commission’s Directorate-General for Enlargement and Eastern Neighbourhood (DG ENEST) provides funding under the third extension of the IPA programme (IPA III).

The project started in January 2024 and covers activities until 2026.

Training events under the Instrument of Pre-accession Assistance

Hands-on training to strengthen regulatory capacity in candidate countries

From 2 to 3 October, EMA held an in-person training simulating real Committee for Medicinal Products for Human Use (CHMP) assessments.

Assessors from national competent authorities in beneficiary countries took part in the event. They represented the following countries:

• Albania
• Bosnia and Herzegovina
• Kosovo
• Montenegro
• North Macedonia
• Serbia
• Ukraine

The Institute for Medicines and Medical Devices of Montenegro (CiNMED) hosted the event. This was the first time that a candidate country hosted an annual assessors training.

For more information, see:

• Institute for Medicines and Medical Devices of Montenegro (CiNMED)

The full agenda of the event is available below:

Agenda - Instrument for Pre-accession Assistance (IPA) training on assessing medicinal products in the EU: A practical introduction

Other IPA training events

Select the expandable panel below to find information on previous EMA trainings held under the IPA programme.

Other IPA training events

• Instrument for Pre-accession Assistance (IPA) EMA training on veterinary aspects of AMR and the One Health approach (October 2024)
• Instrument for Pre-accession Assistance (IPA) advanced EMA training on Clinical Trials, Pharmacovigilance and Shortages (November 2023)
• Instrument for Pre-accession Assistance (IPA) advanced EMA training on Quality and Inspections (June 2023)

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in February 2026.

See update history

2 February 2026

List of EMA working groups updated in section 'EMA's participation in the IPA programme for 2024-26'