EMA welcomes agreement to revise pharmaceutical law in European Union

The European Medicines Agency has endorsed a deal between the European Commission, the European Parliament and the Council of the European Union to reform its pharmaceutical legislative framework for the first time in more than two decades, with proposals that range from faster assessments and expanded digital submissions to tougher supply obligations and tighter antimicrobial safeguards

The European Medicines Agency (EMA) has welcomed a political settlement arrived at between the European Commission (EC), the European Parliament (EP) and the Council of the European Union on a comprehensive reform of European Union (EU) pharmaceutical legislation, in what the EMA has described as the most significant overhaul of the framework in more than two decades. The package is intended to reshape how medicines are developed, assessed, authorised and then made available to patients across the bloc, with a particular focus on regulatory efficiency, resilience of supply and improving preparedness for public health threats.

EMA said the reform represented a rare opportunity to refashion medicines regulation at pan-EU level while maintaining scientific standards. The EMA also said that the revised framework would allow the medicines regulatory network at a pan-EU level to operate with greater agility and efficiency but without any diminution of scientific rigour. In practice, this approach aims to reduce administrative friction, redirect scientific capacity towards areas of greatest need and support faster access to clinically valuable treatments, particularly where unmet medical need remains substantial.

“We will be better positioned to support innovation and ensure that promising novel treatments reach patients faster,” said Emer Cooke, the EMA’s executive director. She added that the legislation would equip the network to deliver its strategy to 2028 and to respond to major public health challenges, including antimicrobial resistance and emerging health threats.

The legislative reform is expected to consolidate and simplify a body of rules that has expanded through multiple legal instruments over many years. EMA indicated that the revision would streamline provisions contained within Regulation (EC) No 726/2004 and Directive 2001/83/EC, alongside legislation that covers paediatric medicines and rare diseases, namely Regulation (EC) No 1901/2006 and Regulation (EC) No 141/2000. The reform also amends the advanced therapy medicinal products (ATMP) Regulation (EC) No 1394/2007, which governs areas such as certain gene therapies, cell therapies and tissue engineered products.

Within EMA itself, one of the most visible changes is expected to involve scientific committee structures for human medicines. Under the agreement, the EMA has proposed to simplify its current committee model to rely on two scientific committees for human medicines: the Committee for Human Medicinal Products (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC).

The agency said the leaner structure would sit alongside stronger support mechanisms that allow the committees to draw on the best available expertise across its network. The EMA also said the reform would increase representation from patients and healthcare professionals, an approach intended to strengthen the relevance of assessments to clinical practice and patient experience.

EMA also expects the streamlined governance model to support shorter assessment timelines. It has indicated that the standard period for evaluation could reduce from 210 days to 180 days, a change that would place pressure on both regulators and applicants to supply clearer, more complete dossiers earlier in development. EMA has presented the reduction as one part of a broader effort to free scientific resources so the network can offer more effective pre-authorisation support to medicine developers, including advice to minimise avoidable delays at the point of application.

Another operational shift concerns the duration of marketing authorisations. Under the proposals, marketing authorisation for a medicine would become valid by default for an unlimited period. EMA said this change would remove routine renewal cycles that can impose administrative burdens without offering proportionate public health benefit, while still allowing the EMA’s scientific committees to require renewals where safety considerations justify closer ongoing scrutiny.

Digital requirements also feature prominently. The reform is expected to require applicants to submit marketing authorisation applications in electronic and structured formats. It would also permit and require companies to make approved product information available electronically, through electronic product information (ePI). In practical terms, ePI can support faster updates, improve consistency across Member States (MS) and allow clinicians and patients to access the latest approved information through digital channels, rather than rely on static and printed documentation that could remain out of date within supply and distribution chains.

Beyond internal process, the pact includes mechanisms intended to help public authorities support innovation, particularly where existing rules can struggle to accommodate novel development models. EMA has referred to provisions that would allow it to offer extended scientific advice in conjunction with health technology assessment bodies or medical device expert panels. This type of parallel engagement can help to align regulatory evidence requirements with reimbursement and clinical adoption expectations, which can differ substantially between jurisdictions and can delay patient access even after authorisation.

The package also refers to strengthened support through the PRIority MEdicines (PRIME) scheme, EMA’s programme that aims to accelerate development and assessment for medicines that may offer a major therapeutic advantage. EMA has framed PRIME as a tool to focus regulatory attention on products that address unmet medical need, particularly where early scientific interaction can improve development plans and the quality of evidence at submission.

Perhaps the most striking innovation is the option for the EC to establish a ‘regulatory sandbox’, at EMA’s suggestion and in consultation with MS. In this context, a sandbox would allow competent authorities to test adapted requirements under close supervision for innovative medicines that do not readily fit within current rules – such as innovative genetic techniques. EMA has presented this as a way to explore proportionate, controlled flexibility without weakening standards, particularly for technologies that develop faster than legislation can evolve.

The reform also anticipates adapted frameworks for certain ‘non-standard’ medicine categories, including personalised therapies. The intention is to reduce structural barriers that can limit patient access where products require individualised manufacturing, highly stratified patient selection or unconventional evidence approaches. EMA has indicated that these areas can offer substantial benefits to patient care but can expose weaknesses in rules designed around mass-produced medicines and classical trial models.

A further section of the agreement addresses paediatric development. EMA has referred to measures to improve efficiency in studies involving children, including the formalisation of iterative paediatric investigation plans (PIPs). A PIP is the agreed plan that sets out how a company will investigate a medicine for use in children. EMA has already piloted iterative approaches and has indicated that formal legal recognition could help to align paediatric plans with emerging adult data and real-world feasibility.

Supply resilience forms another central pillar. The reform proposes stronger obligations for marketing authorisation holders to ensure continuity of supply, alongside duties to notify shortages and withdrawals in advance and to hold shortage prevention plans for prescription medicines. The system would rely on monitoring of expected and actual shortages by both EMA and national competent authorities, based on notifications from companies. The reform also foresees an EU list of critical medicines, for which supply chain vulnerability assessments would take place, an approach designed to identify weak points before shortages disrupt patient care.

Environmental and antimicrobial provisions reflect growing regulatory – and political level – concern about the wider impacts of medicines manufacture and use. EMA said the reform would strengthen environmental risk assessment, including special methodologies to evaluate the risk that antimicrobial manufacture can select for antimicrobial resistance in the environment.

It also introduces provisions to support prudent antimicrobial use, including compulsory medical prescriptions for all antimicrobials, requirements to provide specific information through the package leaflet and an awareness card and the submission of an antimicrobial stewardship plan by applicants.

The agreement remains subject to formal approval by the EP and the Council of the EU. The EMA has said that, once the text has received formal approval, it will work with the EC and EU MS to develop guidance for applicants and marketing authorisation holders, so they can comply with the revised legal framework. The EMA has also said it will keep stakeholders informed and involved as implementation work proceeds on technical and procedural details.

The agency has also indicated that it plans to publish a dedicated web page to act as a gateway and central repository for implementation information, with updates as guidance becomes available and implementation progresses.

The reform process has unfolded over several years with the EC having proposed to reform pharmaceutical legislation in April 2023. EMA and it sister regulatory organisation, the Heads of Medicines Agencies, have provided scientific and technical input to the EC, drawing on experience of operating under the existing EU pharmaceutical framework. The EP adopted its position in April 2024 and the Council of the EU adopted its position in June 2025.