Record Number of New Drug Approvals and Expanded Patient Access

The European Medicines Agency (EMA), with its Executive Director Emer Cooke, announced a total of 104 positive CHMP opinions for new human medicines during 2025 at the European Parliament's Committee on Health (SANT). These recommendations target diseases with high unmet medical needs, including Alzheimer's disease treatments Donanemab (Kisunla) and Lecanemab (Leqembi), Teplizumab (Tzield) for the prevention of type 1 diabetes, and Lenacapavir (Sunlenca) for HIV prevention, administered once every six months. The rapid approval of these high-value biopharmaceuticals is expected to provide new treatment opportunities for patients in Europe who have previously lacked adequate options, while also injecting commercial vitality into the pharmaceutical industry.

Introduction of a New Pharmaceutical Framework, the Largest Regulatory Reform in 20 Years

The EMA is preparing for a major regulatory overhaul, unprecedented in the past 20 years, with the goal of strengthening the global competitiveness of the European biopharmaceutical industry. This reform centers on the introduction of a New Pharmaceutical Framework, which aims to streamline complex new drug review procedures and shorten review times by incorporating digital technologies. By combining regulatory easing and increased transparency, this measure reflects the regulatory authorities' strong commitment to reducing barriers to entry for multinational pharmaceutical companies seeking to enter the European market and encouraging global simultaneous launches of new drugs.

Biotech Act and Critical Medicines Act to Enhance Competitiveness

In order to revitalize the European bio-healthcare ecosystem, close discussions are underway on legislative cooperation, including the Health Technology Assessment (HTA) Regulation, the Biotech Act, and the Critical Medicines Act. In particular, the Critical Medicines Act aims to address recent disruptions in the supply chain and secure pharmaceutical sovereignty by internalizing the production capacity of essential medicines within the region. The Biotech Act is expected to serve as a practical incentive to attract investment and prevent the outflow of talent and capital to the US market by strengthening tax benefits and patent protection for innovative venture companies.

Executive Director's Performance Report and Future Direction at the End of Her Term

Executive Director Emer Cooke, with her term officially ending in April 2027, used this announcement to review the achievements of the EMA's organizational reforms over the past six years. In particular, she demonstrated remarkable growth in the veterinary medicine sector, with 30 positive opinions for veterinary medicinal products, the highest number since 1995. Despite the upcoming leadership transition, the EMA's focus on digital transformation and regulatory streamlining is expected to remain unchanged, further enhancing market predictability.