or any country to become a member of the European Union, a clear set of steps and rules has been established. Such a transition is complex and consists of different stages: the European Council grants countries potential candidate, candidate, or accession status, depending on the status of negotiations. Nine states are currently recognized as candidates for membership in the European Union: Albania, Bosnia and Herzegovina, Georgia, Moldova, Montenegro, North Macedonia, Serbia, Türkiye, and Ukraine. Kosovo formally submitted its application for membership in 2022 and is considered a potential candidate by the European Union.

What is the Instrument for Pre-Accession Assistance (IPA) Programme?

Recognizing the lengthy and arduous journey toward accession and eventual EU membership, the European Commission established the Instrument for Pre-accession assistance (IPA) programme to assist candidate countries and potential candidates in implementing essential political and economic reforms, thereby preparing them for the rights and responsibilities associated with EU membership. The IPA program began in 2007 and is currently in its third iteration with IPA III running from 2021-2027. The results of the IPA Programmes to date are encouraging and have been well-received by all parties involved, paving the way for the next stage of support.

Within the framework of the IPA, the European Medicines Agency (EMA) has been delivering capacity-building projects since 2008, aimed at enhancing the regulatory capabilities in the field of medicines of the national competent authorities (NCAs) in the Western Balkans (Albania, Bosnia and Herzegovina, Kosovo, North Macedonia, Montenegro, Serbia) and Türkiye. Georgia, Moldova, and Ukraine also take part in the program initiatives, although they are not funded through IPA. Through the successful IPA I and IPA II programmes, EMA conducted numerous trainings and facilitated efforts of EU candidate countries to align with EU legislation on medicines regulation.

This article focuses on the outcomes of an impact assessment of the IPA II cycle, conducted by EMA through a semi-anonymous survey, followed by interviews with the representatives from the 10 (potential) candidate NCAs (including Georgia, Moldova, and Ukraine) to assess the effectiveness of the assistance delivered between 2020-2023. The survey does not prejudice the evaluation by the European Commission in the context of accession discussions.

EMA’s Implementation of IPA

EMA’s IPA intervention is aimed at strengthening the local NCA assessment capacity for medicinal products for human and veterinary use, increasing scientific cooperation among national health products regulatory authorities of EU (potential) candidate countries as well as with EU Member States and EMA. Additionally, it aims to foster preparedness and harmonization of medicines regulation in these countries with the EU Acquis Communautaire (the body of common rights and obligations that is binding on all the EU member states). Activities delivered under the IPA framework include:

• Organizing targeted conferences and training sessions to exchange views, explain the EU legal framework in the field of medicines, and pinpoint areas requiring further action
• Supporting beneficiary countries of (countries that benefit from) the IPA program in their participation at EMA working group meetings and training courses as observers
• Granting beneficiary countries access to selected eLearning modules in the EU Network Training Centre (EU NTC).

Results of an impact assessment of the IPA II cycle indicate that the initiative to enhance the capacity of the (potential) candidate countries to align with EU standards through training and dialogue is proving effective. Through a questionnaire followed by interviews, beneficiary NCAs self-reported being partially or substantially aligned to the EU acquis, which can be attributed to the training sessions provided. During the IPA II cycle, 600 experts from regulatory bodies from EU candidate countries participated in virtual and face-to-face webinars/trainings. Additionally, a dialogue platform was established between the EMA and the beneficiary NCAs, facilitating discussions on priority regulatory matters and the exchange of information on shared interests. Notably, the dialogue platform, initially deemed of lesser significance during the project design phase, gained prominence during the COVID-19 pandemic.

IPA beneficiaries have emphasized that the face-to-face interactions and exchanges facilitated by EMA and the EU regulatory network with all its member states’ national competent authorities are particularly valuable, as they provide a forum for addressing critical issues. Participants also acknowledged the impact these interactions have made on the development and revision of legislation to align it further with EU acquis. Furthermore, they noted that the IPA program improved understanding of the nuances of the EU regulatory framework, including the decision-making process, assessment procedures, and scientific advice processes as well as issues related to shortages and inspections.

In general, the IPA program has been perceived as having a positive impact, including fostering a more favorable sentiment towards EU accession, enhancing visibility, and providing exposure and networking opportunities with other authorities, particularly thanks to the face-to-face events organized in 2023. However, participants observed that, despite the sustained commitment from the European Commission and EMA, the extent of this assistance remains fairly unrecognized in Western Balkans and Türkiye.

IPA participants highlighted various advantages gained from taking part in the program emphasizing alignment with EU legislation:

“With the help of the IPA II programme activities, Kosovo has made significant strides in improving and aligning its legislation with EU acquis. A concrete example of this effort is the new guideline on variations, which aims to streamline procedures to meet European standards. Progress has also been made in drafting legislation for medicinal products and devices, which is now in the final stages of preparation, along with the development of a guideline for registering medical devices—key steps to enhancing quality and safety in the healthcare sector in Kosovo.” Bosnian participants acknowledged that the IPA project has enabled them to better understand regulatory processes focusing on how the risk-based approach is or will be applied and implemented in Bosnia.

Similarly, North Macedonian participants noted that “With the support provided, along with the dissemination of knowledge and trainings, we have started alignment with EU legislation in the areas of marketing authorization of veterinary medicinal products, good manufacturing practices, pharmacovigilance, antimicrobial resistance and use, to strengthening the regulatory framework and building the capacity of the national competent authority in North Macedonia.”

Participants from Montenegro also highlighted the positive impact of the program on their internal procedures: “The IPA II cycle has been a cornerstone for the reform efforts in the Institute for Medicines and Medical Devices of Montenegro, allowing substantial improvements in internal processes and procedures. As part of these efforts, the institute adopted 11 new Standard Operating Procedures and revised 19 existing ones, significantly enhancing the consistency, transparency, and efficiency of its operations. Additionally, five new internal instructions were issued providing clearer guidance on regulatory procedures and ensuring better compliance with international best practices in Montenegro.”

North Macedonian participants pointed out the usefulness of the topics covered in the Action and noted that the areas of focus, particularly GMP, GCP, and GVP as well as the assessment of generic medicines, met the expectations and needs of their national regulator. No less important, it was emphasized that IPA contributed to fostering unity between European Union and candidate countries through continued interactions between regulatory professionals from both areas as well as the exchange of knowledge and expertise. Serbian participants noted how IPA II contributed to the sentiment of being part of the European regulatory network as observers, respected experts, and colleagues.

In addition to activities under the IPA program, the European Commission also offered the possibility to participate in twinning programs with other EU NCAs. Montenegro took part in a twinning program with Croatia from 2021-2022 and, as a result, 10 by-laws in the field of medicines and medical devices were prepared and the adopted Development Strategy of the Institute for the period 2022-2026 was formulated. Inspired by this success, Montenegro started another twinning project with Malta. The goal of the project is to continue strengthening the administrative capacity and internal competences of the Institute for Medicines and Medical Devices of Montenegro so that it can meet the requirements of the EU accession process through joint practical work in the areas of evaluation of marketing authorizations, inspections, and medical devices.

Although acknowledging the benefits of the assistance received, beneficiary agencies received a lot of material to absorb, which then needed to be translated into the implementation of new or revised laws and regulations at operational level. Thus, more hands-on trainings were requested, together with the possibility to attend existing working groups and parties as observers. Additionally, beneficiaries emphasized the need for greater focus on veterinary medicines, particularly concerning registration procedures.

Moreover, beneficiaries pointed out that the ongoing revision of the EU pharmaceutical legislation presents challenges for countries that look to the EU as a model for updating their own legal frameworks. These considerations were integrated into the planning of activities under IPA III.

EMA Next Steps and Future Plans

Considering the feedback obtained from beneficiaries, the ongoing IPA III cycle has begun supporting the involvement of observers in various working groups and offering possibilities for joining ad hoc trainings organized by EMA. The idea is to scale up participation in various EMA working groups and trainings as candidates move closer to accession status.

Taking into account the demand for increased focus on veterinary regulation, the first training session under IPA III concentrated on the regulatory dimensions of antimicrobial resistance (AMR) in veterinary pharmaceuticals. Going forward, the intent is to improve the applicability of these training sessions by incorporating simulated product assessment exercises.

The expansion of the IPA project goes hand-in-hand with EU enlargement, being broadly recognized as a high political priority for the coming years in Europe. EMA is committed through the IPA program to its continued assistance to (potential) candidate countries in navigating the intricate process of accession in the field of medicines regulation.