EU legislators reach agreement on landmark pharmaceutical package

The European Commission, the European Parliament, and the Council of the European Union have agreed on a significant reform of the EU’s pharmaceutical legislation. If the proposed legislation is adopted, it will reportedly simplify the drug regulatory regime within the economic zone, promote innovation, and secure the drug supply chain, according to EU officials.

On 11 December, the EU Parliament reached a provisional agreement with the other EU bodies to update Europe's drug policy framework. A key aspect of the agreement is to simplify the EU drug regulatory environment by reducing the European Medicines Agency's (EMA) human drugs committee structure from five scientific committees to two. The remaining two committees will be the Committee for Human Medicinal Products (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC).

"Today marks a historic milestone for European medicines regulation and for patients across the EU," said EMA Executive Director Emer Cooke. "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," she added. "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."

The regulatory changes would mean that EMA will review drug marketing applications within 180 days instead of the current 210 days, which the agency said will free up scientific resources and allow it to provide drug developers with more pre-authorization support. Furthermore, it stated that the reform will mean that marketing authorization will be granted by default for an unlimited period, thereby eliminating the need for marketing authorization holders (MAHs) to renew their applications unless a safety concern arises.

The EU Parliament also noted that the proposed legislation would give MAHs regulatory data protection for eight years. During that time, other companies would not be able to access data on the authorized product, and an additional year of market protection. Drugmakers would also be eligible for an extra year of marketing protection for their drug if certain conditions are met, such as if the drug addresses an unmet need, up to 11 years of combined regulatory protection.

EMA stated that the reform would require drug applicants to submit their applications in electronic and structured formats, and that product information must be available in electronic form (ePI).

In addition to the regulatory reforms, European legislators and regulators stated that the updated pharmaceutical legislation will enhance drug innovation by enabling EMA to provide extended scientific advice to drug developers in collaboration with health technology assessment (HTA) bodies and medical device expert panels. EMA said it also suggested that the Commission establish a "regulatory sandbox" as part of the legislation to test and develop adapted regulatory requirements, allowing the development of new drugs that can't be developed under current rules.

The legislation would also create adapted frameworks for certain non-standard treatments, such as personalized medicines, and improve the pediatric investigation plan (PIPs) process, which the EMA is evaluating as part of a pilot.

The proposed legislation is also intended to strengthen the drug supply chain by introducing several new rules, including establishing new drug shortage reporting requirements for manufacturers and creating a European list of critical medicines that require monitoring, as well as enhancing the EU's capacity to address antimicrobial resistance (AMR).

“Companies holding marketing authorizations for medicinal products would be required to put in place and update shortage prevention plans for medicinal products subject to prescription and medicinal products that would require a shortage prevention plan identified by the Commission,” said the EU Parliament. “Shortages would be monitored at both national and EU levels, and the EMA would establish and update a list of critical shortages in the EU.

“Negotiators agreed to introduce a ‘transferable data exclusivity voucher’ for priority antimicrobials, giving the right to 12 additional months of data protection for one authorized product,” the Parliament added. “The 12-month extension may be used once, for the priority antimicrobial or for another centrally authorized medicinal product of the same or different marketing authorization holder.”

The proposed legislative reforms will need to be approved by the EU Parliament and the Council; however, there is no specific timeline for when that will happen.

"Over the coming months and years, once the text has been formally approved, EMA will work together with the European Commission and EU Member States, to develop relevant guidance for applicants and marketing authorisation holders to comply with the new legal framework," said EMA. "To ensure the smooth implementation of the legislation, EMA’s stakeholders will be kept informed and actively involved in the implementation process on specific technical and procedural aspects of the reform.

"EMA plans to publish a new web page that will serve as a gateway and central repository of information on implementation of the new legislation for EMA’s stakeholders," the agency added. "The webpage will be updated as implementation work progresses and guidance for pharmaceutical companies becomes available."

The lobby group, European Federation of Pharmaceutical Industries and Associations (EFPIA), argued that while the proposed legislation marks a significant moment in shaping the future of the drug industry in the EU, it is not strong enough to boost competitiveness in the region. The group said the legislation maintains eight years of regulatory data protection, which is an improvement on the Commission's previous proposal, and argued that certain compromises in the legislation will frustrate intellectual property enforcement and create legal uncertainty.

"These compromises are from a previous political era and will make no difference for a sector already losing ground," said EFPIA. "To compete in 2026 and beyond, Europe requires policies that can halt the negative trends of previous years while also countering the fallout of recent global pricing and trade policies, ensuring that we can continue to lead global innovation in medicines and vaccines.

"In this sense, the updating of the EU’s regulatory framework provides an important shift, with encouraging steps towards reducing EMA timelines and the ability to compete with the FDA and other global medicines agencies," the group added. "The introduction of a regulatory sandbox strengthens Europe’s toolbox for supporting breakthrough innovations. We support the long-awaited transition to electronic product information, bringing essential flexibility and aligning regulation with technological progress."

The rare disease advocacy group EURODIS, however, was more optimistic about the deal, stating that it was a momentous advancement for people with rare diseases.

"By establishing modulated incentives for all medicines, as well as for orphan drugs – including through the new ‘breakthrough orphan medicinal products’ category, which grants longer market exclusivity for certain new therapies – Europe has created the conditions to stimulate innovation, including for the rarest and most complex conditions. The package also delivers practical reforms, including shortened EMA timelines and strengthened supply safeguards, that should speed up approvals and help ensure medicines reach patients," said EURODIS President Avril Daly. “Wisely, the agreement also allows the Commission to enable more adaptable pathways, including by creating regulatory sandboxes under strict conditions – a pragmatic route to test innovative therapies."

EU Parliament statement

EMA statement

EU legislators reach agreement on landmark pharmaceutical package

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