he recent series of sessions on pharmaceutical regulations and industry practices at DIA’s Southeastern Europe (SEE) Region Regulatory Conference highlighted key areas of development, challenges, and strategic directions for the future of the SEE region. Discussions ranged from the new EU pharmaceutical legislation to reliance practices, harmonization, pharmacovigilance, supply chain security, and digital transformation. This conference underscored the importance of collaboration, harmonization, reliance, and digitalization in enhancing pharmaceutical regulations and practices in the region. By addressing these key areas, the region can improve healthcare outcomes, accelerate EU accession, and ensure the efficient and secure supply of medicines to its patients.

EU General Pharmaceuticals Legislation and Its Impact on the SEE Region

Key Takeaways: The new EU pharmaceutical legislation aims to create a robust, agile, future-proof regulatory framework that fosters innovation and benefits patients, health systems, and society. A revised EU Variation framework and new classification guidelines are set to simplify the legal landscape, making it more adaptable to scientific advancements and operational needs. Five non-EU SEE countries have been recognized as candidates for membership in the European Union (EU) and have opened EU accession talks: Albania, Bosnia and Herzegovina, Montenegro, North Macedonia, and Serbia. Among other directives, candidate countries must transpose and implement the European directive for medicines into their national legislation. Currently, the level of alignment with EU legislation within the SEE region is varied. Harmonizing regulatory frameworks in non-EU SEE countries is the key to unlocking their EU Accession journey, streamlining operations, and accelerating patient access to medicines. To keep pace with the EU variation framework, panelists representing senior leadership from industry and regulatory agencies, both within and outside the EU, agreed that the region should enable effective implementation of the EU regulatory updates to make their regulatory processes more flexible, efficient, and easily aligned with EU requirements. Effective collaboration between regional, EU, and international health authorities is essential for overcoming challenges (such as increased workloads, resource limitations, need for upskilling, etc.) and will help countries in the region to better prepare for their EU accession.

Next Steps: Regional regulators must continue to monitor EU regulatory progress, and ensuring swift implementation of new regulations in the SEE region is necessary. Facilitating effective integration of EU updates will maintain a steady supply of and quick access to new medicines. Promoting further harmonization with EU Acquis will help the countries better prepare for EU accession and improve healthcare outcomes. Enhancing regional, EU, and international HA collaboration will build capabilities, drawing on successful models like the New Collaboration Agreement between Drug Regulatory Authorities in Central and Eastern European Countries (nCADREAC), which encompasses both the Centralised (CP) and Mutual Recognition/Decentralised (MRP/DCP) Procedures.

Reliance

Key Takeaways: Reliance, while not a new concept, is emphasized by WHO for better resource utilization and global regulatory oversight. Achieving equitable access to quality medicines requires integrated stakeholder engagement. EMA’s decision-making, captured in the European Public Assessment Reports (EPAR), underlines the importance of transparency and trust in regulatory processes. One of the EMA presenters clearly emphasized that international collaboration and reliance are necessities, not choices, for regulatory processes.

Next Steps: Starting small with reliance pilots and expanding based on measured impacts will be essential. Building transparency and communication among stakeholders will optimize reliance across the medicine lifecycle. Industry and regulators need to clearly convey the requirements and benefits of reliance.

SEE Townhall

Key Takeaways: Reliance helps manage regulatory resources and accelerates medicine availability. However, one industry presenter noted that while reliance has been implemented for Initial Marketing Authorization in SEE countries, its broader application to post-approval changes (PAC) faces challenges like product sameness and regulatory backlog. Harmonization with EU regulations is essential for SEE countries’ EU accession and a key enabler for reliance. Local regulators stated that trust and shared best practices are crucial for regional cooperation and reliance.

Next Steps: Regulators are encouraged by industry and EMA to continue engagement in pilots to practice reliance, to build trust and collaboration, and to explore a more flexible approach of incorporating reliance in guidelines without changes to regulations. Regulators and industry are encouraged to share the learning from PAC reliance pilots more broadly to promote the implementation of reliance. Regulators are also encouraged to leverage ongoing collaborations with EMA and EU member states (such as the Instrument for Pre-accession Assistance (IPA) program) to strengthen regulatory systems. All stakeholders should maintain an open and transparent dialogue.

Pharmacovigilance

Key Takeaways: Targeted education, and national and international collaboration, enhances pharmacovigilance (PV) systems. Reliance is vital for small countries with limited resources, emphasizing work-sharing. PV systems must adapt to local specificities and embrace new technologies.

Next Steps: Sustaining safety reporter motivation through continuous education will be crucial. Fostering existing collaborations (such as continued participation in EU Twinning projects between EU Member States and non-EU states, for example) and initiating new ones will enhance PV systems. Rapidly integrating new technologies and artificial intelligence (AI) into national PV systems will improve efficiency and effectiveness.

Ensuring Uninterrupted and Secure Supply to Patients

Key Takeaways: Product shortages are a global issue, often affecting trust in the healthcare system and leading to counterfeiting. Multistakeholder engagement and communication are necessary to address shortages. EMA and other agencies are working on mitigating shortages. Regional shared packs and digital solutions like electronic product information (ePI) and electronic package leaflets (ePLs) can help alleviate supply vulnerabilities.

Next Steps: Assessing other regulatory flexibilities, such as more flexible stakeholder engagement opportunities and extending the flexibility of a product’s shelf life, to prevent shortages will be important. Utilizing EU/global reliance pathways to accelerate approvals and mitigate shortages is also strongly recommended. Promoting regulatory convergence and greater regional Healthcare Authorities coordination will improve supply chain security. Ensuring high product quality and combating counterfeits will maintain trust in the pharmaceutical system.

Digitalization

Key Takeaways: Leveraging existing solutions and best practices is crucial for efficient digital transformation. eSubmissions streamline review and approval processes and ensure data integrity and security, while transitioning to eCTD format enhances collaboration, alignment with ICH standards, and related benefits.

Next Steps: Overcoming traditional mindsets and practices through change management, and continuously educating and upskilling SEE regulatory staff, will be necessary to support digital transformation. Exploring financial opportunities to support digital initiatives will ensure sustained progress.