EMA Calls New EU Pharma Legislation Most Significant in Two Decades

On Dec. 11, 2025, the European Medicines Agency (EMA) positively responded to the news that the European Commission (EC), the European Parliament, and the Council of the European Union have reached an agreement to comprehensively reform pharmaceutical legislation in the EU (1). The agreement to move forward with a 2023 proposal by the European Commission was announced on Dec. 11, 2025 (2). The reform will grant regulatory data and market protection for a period of eight years with additional years given to drugs developed for unmet needs and other considerations.

According to EMA, with this reform, the development and authorization of drugs will be modernized and procedures will be simplified. Current regulations that will be impacted will include Regulation 726/2004 and Directive 2001/83/EC, Regulation 1901/2006 and Regulation 141/2000/EC (medicines for children and rare diseases, respectively), and the advanced therapy medicinal products (ATMP) Regulation 1394/2007.

“Today marks a historic milestone for European medicines regulation and for patients across the EU,” said EMA’s Executive Director Emer Cooke in a press release (1). “The revamp of the pharmaceutical legislation will enable EMA and the European medicines regulatory agencies network to become more agile and efficient while upholding the highest standards of scientific rigor.”

“By simplifying procedures, embracing digitalization, and rationalizing our use of scientific resources, we will be better positioned to support innovation and ensure that promising new treatments reach patients faster,” Cooke added in the release (1). “The new legislation also provides us with the tools to deliver on our network strategy to 2028 and address the major public health challenges of the future, from antimicrobial resistance to emerging health threats.”

How will the reform impact EMA procedures?

The agency’s committee structure will be made leaner and will be complemented by increased patient and healthcare professional representation. This includes the Committee for Human Medicinal Products and the Pharmacovigilance Risk Assessment Committee.

Assessment times will be reduced from 210 days to 180 days, freeing up scientific resources for pre-authorization support for drug companies. Digital solutions will include the requirement for drug applicants to submit market authorization applications in electronic formats and provide product information in electronic form.

Possibly one of the most interesting changes is that market authorization of a drug will be valid by default for an unlimited period. The agency states this will avoid unnecessary administrative burden surrounding renewals, unless required for safety reasons determined by EMA’s scientific committees.

How will these changes improve innovation?

The agency states that. with these reforms, it will be able to offer extended scientific advice with health technology assessment bodies and strengthen support for drugs under priority medicine designation. EMA will also be able to request that the EC establish a regulatory sandbox to test requirements for innovative medicines that cannot be developed under the current rules.

Adapted frameworks may also be created for certain non-standard drug categories, and process inefficiency improvements for pediatric medications can be established, such as the formalization of a new process from iterative pediatric investigation plans.

When will the changes be final?

The agreement is subject to formal approval by the European Parliament and the Council and may take months to years to be finalized. During that time, EMA will work with the EC and EU Member States to develop guidance documents to help drug developers comply with the new rules. EMA will be keeping stakeholders informed as the process goes forward and has plans for an information repository web page available for pharmaceutical companies.

References

1. EMA. EMA Welcomes Political Agreement on New EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation
2. European Parliament. Deal on Comprehensive Reform of EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. https://www.europarl.europa.eu/news/en/press-room/20251209IPR32110/deal-on-comprehensive-reform-of-eu-pharmaceutical-legislation