EU Officials Tout Pending Pharmaceutical Reforms
核心洞察
European Commission and EMA officials outlined pending EU pharmaceutical legislation that would replace two decades of rules with a new Directive and Regulation.
The reforms would cut the EMA from six committees to two and reduce scientific assessment time from 210 days to 180 days.
An antimicrobial voucher granting an extra year of data protection aims to incentivize developers targeting multi-drug-resistant organisms.
European Commission and European Medicines Agency (搜索) officials used a panel at RAPS Convergence 2026 to detail the pending overhaul of the EU pharmaceutical legislative framework. Antonios Rodiadis, a policy officer at DG SANTE, described the proposal as a structural shift in EU pharma policy, built on a new Directive and Regulation intended to complement the proposed Critical Medicines Act, Biotech Act and the Medical Device Regulation. He cited access disparities across member states, with some larger countries reaching 80% of authorized drugs in 2025 while smaller ones had access to less than 20%, and a current authorization time of 430 days.
The reforms would restructure the EMA from six committees to two, one for human medicinal product authorizations and one for pharmacovigilance, replacing a process in which a pediatric rare disease advanced therapy could pass through five committees. Other measures include eliminating authorization renewals, phased data reviews for products of major public health interest, and cutting scientific assessment from 210 days to 180 days, with accelerated reviews possible in 150 days. Rodiadis said the simplification is calculated to reduce costs by €300 million annually for authorities and industry.
Additional provisions cover digital and data-driven regulation, including regulator access to health registries, hospital databases and biobanks, electronic premarket submissions and electronic-only product information. The proposal also envisages regulatory sandboxes, adapted frameworks for novel medicines, early EMA support, authorization of platform technologies such as messenger RNA vaccines (搜索), and decentralized manufacturing. A voucher would grant an additional year of data protection to developers of antimicrobials addressing multi-drug-resistant organisms, sellable on the private market.
Lilia Luchianov, also a DG SANTE policy officer, said the antimicrobial voucher, regulatory sandboxes, international regulatory cooperation and certain EMA grants would apply immediately, while monitoring, shortage management and access provisions would phase in between six months and two years after enactment. Sabine Haubenreisser of the EMA said the agency has reviewed the text from day one, completed a gap analysis and allocated resources, and will convene a multi-stakeholder workshop once the legislation is approved and published. Claudia Dollins of GSK, speaking for EFPIA, called the change profound and said industry needs reasonable timelines, pragmatic requirements and clarity on product scope, with more than 100 implementing actions ahead.
Source: RAPS