21 Oct Europe at a Crossroads in Regulation, Innovation and Access

Reflections from BADI’s 15th Anniversary

The 15th anniversary of the Bulgarian Association for Drug Information (BADI) was more than a celebration of history. It was a forward-looking discussion about the future of regulatory affairs, the pharmaceutical industry and market access in Europe. Bringing together regulators, experts and industry leaders, the event reaffirmed BADI’s founding vision:

“To build and maintain a strong regulatory society in Bulgaria, a community of educated experts dedicated to healthcare innovation.”

At a time when the European pharmaceutical system is undergoing its most significant reform in three decades, the discussions at BADI’s forum explored how science, technology and ethics must evolve together to shape the next era of medicine.

Bulgaria’s Regulatory Path from Capacity Building to European Leadership

Bogdan Kirilov, Executive Director of the Bulgarian Drug Agency (BDA), presented Bulgaria’s progress in regulatory affairs. Over the past decade, the agency has strengthened its international role and achieved several important milestones. The U.S. FDA’s recognition of BDA’s GMP certificates in 2019 and Bulgaria’s 2023 accession to the PIC/S network were defining moments that established Bulgaria as a trusted partner in global regulatory collaboration.

Yet challenges remain. The BDA’s capacity is constrained, handling only four international reference procedures annually, and many well-trained specialists eventually move to the pharmaceutical industry for higher remuneration. Retaining expertise in the public sector is now a strategic priority for sustaining Bulgaria’s growing regulatory role.

At a national level, the BDA’s activities align with Europe’s broader priorities:
• Accessibility through the Specialized Electronic System for Monitoring and Analysis of Medicinal Products included in the Positive Drug List, which ensures transparency, traceability and evidence-based market management
• Digitalization accelerated by the COVID-19 pandemic, enabling more efficient workflows, data exchange and automation
• Verification where Bulgaria ranks third in Europe with a 90 percent decommissioning rate (EMVO, May 2025), demonstrating strong compliance with European safety measures
• Antimicrobial resistance (AMR) where progress includes electronic prescriptions, tighter pharmacy control, vaccination campaigns and public awareness initiatives

Kirilov also commented on the growing role of artificial intelligence in regulation. Although personally cautious about its widespread adoption, he acknowledged that AI represents the future of efficient, data-driven regulatory processes, pharmacovigilance and quality oversight.

EMA’s Vision for Innovation that Reaches the Patient

Emer Cooke, Executive Director of the European Medicines Agency (EMA), brought a European perspective through the European Medicines Agencies Network Strategy 2028. Her central message resonated across all discussions:

“Innovation matters only if it reaches the patient.”

Cooke outlined how the EMA is using digital tools and artificial intelligence to improve regulatory science and decision-making. The Scientific Explorer platform allows regulators to perform focused and precise searches across vast scientific databases, saving time and improving the consistency of assessments.

Other AI-driven projects address rare diseases, medication error prevention and supply chain monitoring, moving regulators from a reactive to a preventive mode of operation.

Cooke also discussed EMA’s engagement with EU Biotech Hubs, a pilot initiative, aimed at supporting early-stage biotechnology companies that often lack awareness of regulatory requirements. By fostering this dialogue, EMA helps innovators integrate regulatory science early in product development, reducing delays and market access barriers.

Another transformative concept is the Regulatory Sandbox, a controlled testing environment where novel technologies can be evaluated safely before formal implementation. Cooke expressed enthusiasm about its potential to modernize European regulatory practice and ensure that the system remains adaptive to digital innovation.

She also stressed that the ongoing revision of the EU pharmaceutical legislation presents a unique opportunity to make Europe more attractive to innovation by simplifying procedures, reducing administrative burdens and reinforcing trust in science.

Revising European Pharmaceutical Legislation for Competitiveness and Cooperation

Former EMA Management Board Chair Christa Wirthumer-Hoche expanded on the relationship between the new Pharma Review and the Critical Medicines Act (CMA). Both frameworks aim to ensure the availability of critical medicines while preserving Europe’s competitiveness in the global pharmaceutical industry.

Her insights underscored the need for a coordinated European approach:
• A single EU Critical Medicines List to replace fragmented national registers
• Regulatory incentives and extended exclusivity periods to sustain pharmaceutical R&D investment
• Local production and supply chain diversification to reduce dependency on Asian manufacturers
• Broader worksharing mechanisms such as joint assessments of Active Substance Master Files (ASMF) to support smaller national agencies like Bulgaria’s

A new ASMF certification system, valid across the EU and managed by the EMA, is expected to simplify quality assessment procedures and reduce duplication of work.

Wirthumer-Hoche also discussed AI’s emerging role in regulation, highlighting its potential to automate product information preparation, forecast supply disruptions, optimize stock management and enable risk-based inspections. However, she emphasized the importance of ethical frameworks and guiding principles for responsible AI use in the regulatory environment.

Market Protection, Repurposing and the Economics of Innovation

In the second session, Barbara Sickmueller, President of the German Society for Regulatory Affairs (DGRA), delivered a detailed analysis of the proposed EU legislative changes. She supported maintaining the existing structure of regulatory protection with eight years of data protection, two years of market protection and one year for a new indication. According to her, this model provides the stability required for sustainable innovation in the pharmaceutical industry.

Sickmueller also emphasized the importance of drug repurposing, developing new therapeutic uses for known substances as a strategic opportunity to improve patient access and reduce costs.

Repurposing aligns perfectly with Europe’s goals of sustainability and affordability. Drug repurposing is where regulatory flexibility meets public health value. It offers faster, safer and more accessible solutions for patients.

Further discussions addressed paediatric medicines, antimicrobial resistance and the Transferable Exclusivity Vouchers concept. Participants agreed that the EU must preserve incentives that drive research in neglected and paediatric indications while balancing affordability and innovation.

Bulgaria’s Role in the European Regulatory Landscape

Bulgaria’s representative in the CHMP, Lubina Todorova, provided a national perspective on the operational realities within smaller agencies. She discussed the limited number of available reference procedure slots, issues with inconsistent applicant behavior and the workload challenges arising from new variation regulations.

While work-sharing mechanisms can reduce the burden on assessors, administrative teams face increasing responsibilities for validation and coordination. Todorova’s intervention reinforced a broader theme of the event that regulatory modernization must be realistic, inclusive and adequately resourced.

BADI’s President Prof. Tatyana Benisheva closed the anniversary forum by underlining the association’s enduring mission to act as a bridge between regulators, academia and the pharmaceutical industry. For 15 years, BADI has been a key institution in cultivating regulatory expertise, ensuring that Bulgaria remains a respected contributor to the European regulatory community.

Intelligent Regulation for a Smarter Future

Europe is entering an era of intelligent regulation. Artificial intelligence, data transparency and digital workflows are redefining not only efficiency but also trust. The real challenge is to use these tools wisely to serve both innovation and public health.

The 15th anniversary of BADI was not just a look back but a bold vision forward. As Europe redefines its pharmaceutical legislation and regulatory strategies, Bulgaria stands ready to contribute expertise and leadership. The country’s growing role in regulatory affairs, pharmacovigilance and digital transformation illustrates a broader European truth that smart regulation is the foundation of better, more equitable healthcare for all.