Euro Convergence: EU pharmaceutical overhaul brings challenges, hope for better regulation

LISBON – Industry representatives, patients, and regulators shared their perspectives on the reforms to the EU pharmaceutical legislation at RAPS Euro Convergence 2026. The panelists noted that many challenges remain as lawmakers and regulators work to implement the law but expressed hope that it will bring much-needed improvements to the EU regulatory system.

Antonios Rodiadis, a DG SANTE policy officer at the European Commission, said the pharmaceutical package revises 20 years of EU pharmaceutical rules. The main objective of the legislation, he said, is to simplify and streamline the regulatory system for drugs, while ensuring their safety, efficacy, and quality, in order to make the EU market more competitive and to improve access, availability, and affordability.

"Essentially, it's future proofing the current framework so that in the future we're able to deal with new medicine, new innovation that is currently challenging the system in terms of novel regulatory approaches," said Rodiadis.

Rodiadis highlighted key components of the legislation, including regulatory sandboxes for products that would otherwise be difficult to authorize as they don't fit within the current regulatory system. This includes new manufacturing techniques, the integration of autonomous artificial intelligence (AI), and new methods of drug delivery.

"These are things that are challenging currently the rules and therefore regulatory sandboxes are able to deal with those potentially future ones in safe environments where we can take the learnings from those pilots and integrate them into a business as usual through a system we call adaptive frameworks, whereby the Commission is empowered to tweak certain rules ... to fit to new technologies, always keeping the principles of safety, of the efficacy untouched," he added.

Rodiadis also touted other aspects of the legislation, including vouchers for priority antimicrobials, early regulatory support from the European Medicines Agency (EMA), decentralized manufacturing, clarity for products subject to multiple regulatory frameworks, and more. He noted that the legislation also reforms EMA committees, streamlines regulatory procedures, implements phased reviews of data for medicines of major interest, and reduces scientific assessments from 210 days to 180 days, or as little as 150 days for certain products. Additionally, he emphasized that the new system would be digital and data-driven, meaning real-world evidence and health data can be used for regulatory purposes, marketing authorization applications will be submitted electronically, and product information will also be available in electronic format.

Rodiadis said the package is undergoing linguistic review, and final sign-off from the EU Parliament is expected in September, while final sign-off from the European Council is expected in October. The legislation is expected to take effect in December, triggering a two-year implementation phase, he said, noting that some parts of it will go into effect even sooner. He also said the Commission is planning a conference on the new legislation at the beginning of December and told attendees to look out for save-the-dates to register for the conference in early September.

Bruno Sepodes, chair of EMA's Committee for Medicinal Products for Human Use (CHMP) and a senior expert at Portugal's National Authority for Medicines and Health Products (INFARMED), described the reforms as forward-thinking but said there may be challenges ahead.

"I think this collaboration that we have is a competitive advantage," he said. "We have now the opportunity to streamline processes ... and to position ourselves more as leaders in this area."

Sepodes acknowledged that there are some weaknesses in developing such a large piece of legislation with so many stakeholders involved, including difficulties in reaching consensus, the speed of decision-making, and the administrative burden. However, he said the reforms will ultimately provide a simpler regulatory environment, stronger safeguards against medicine shortages, more support and improved conditions for innovation, and better environmental protection and focus on antimicrobial resistance (AMR).

Sepodes emphasized the reform of the EMA's committee structure. He noted that the traditional structure has required many interactions, and the proposed new structure will be enriched with strong connections to the working parties and will include more voices, including healthcare professionals and patients, to help inform regulatory decisions.

The new centralized committee structure will mean a stronger CHMP and Pharmacovigilance Risk Assessment Committee (PRAC) oversight, Sepodes said, which will enable the streamlining of regulatory procedures, expertise, and resources. He added that the reforms will facilitate the phased review of data for medicines of major interest, lead to a significant reduction in scientific assessment times, and offer additional incentives for orphan drugs and medicines for unmet medical needs.

"As you can see, the work is already ongoing, the streams are starting to work on the priorities, and then we'll deliver all the rest," said Sepodes. "We hope that with the structure and proper interaction with stakeholders, we will be able to deliver, and you will see the results of this in the coming months, and by 2028, we will be ready."

Marta Marcelino, head of regulatory strategy and innovation at INFARMED and chair of the Co-ordination Group for Mutual Recognition and Decentralized procedures - Human (CMDh), agreed that there will be a lot of work ahead for regulators and other stakeholders over the next few years as the legislation goes into effect and highlighted the Mutual Recognition Procedures (MRP).

Marcelino noted that an MRP application will be submitted to the national competent authority (NCA) of the member state that granted the marketing authorization and the concerned member state (CMS) where the applicant is seeking a national marketing authorization. She also noted that no MRP would be accepted within the first year after a national procedure (NP is granted unless certain NCA conditions are met for the Reference Member State (RMS).

"It is foreseen that the application should be submitted to the RMS and CMS at the same time... and that generally no MRP should be accepted one year after the purely national granting of the marketing authorization," said Marcelino. "This is unless there is this specific information from a member state to the RMS that considers that medicinal product is of interest in its own territory."

Marcelino also discussed the new MRP timelines as part of the package, and the decentralized opt-in procedure, which she noted still has many questions, not just from industry but also from regulators.

"It is also important that we have this forum where we can have your contributions and your requests for clarification," said Marcelino. "In this case, the opt-in procedure is foreseen for MRP and DCP, and when submitting marketing authorization to the reference member state, you should inform all member states of this, even if they are not concerned member states.

"That [way] member states will then have the possibility of requesting to join the procedure that will be mainly focused on the needs of that market," she added.

Marcelino noted that the new MRP and DCP marketing authorization procedures are intended to ensure higher-quality dossiers, require universal opt-in obligations, faster and more streamlined procedures, harmonized summaries of product characteristics (SmPCs), an unlimited validity period, and require NCAs to refuse validation of purely national applications where the same product is being assessed or already authorized in another member state.

Inês Alves, a researcher at the University of Évora and a patient advocate at the National Association for Skeletal Dysplasias, Portugal (ANDO Portugal), said the patient community has high hopes that the legislation will lead to better outcomes. However, she also said expectations need to be grounded and noted the difficulty patient representatives face in participating in ongoing regulatory discussions due to limited time and resources.

"We need to keep on collaborating closely with the patient community, with patient organizations with rare or prevalent conditions to make sure that the development that is ongoing is going to deliver something that is for an unmet need," said Alves. "This new legislation is hitting the speed and hoping for quality on that speed, but we cannot grant that the speed will happen if procedures or submissions don't have enough quality."

"I started as a patient representative, super enthusiastic on having a contribution for that community, but at that point, five years ago, I just wanted a medicinal product for today and realized in these five years that most applications are really with low quality data," she added. "The expectations is that when a medicinal product is granted an orphan designation or is centrally approved, it will be effective and it will be accessible."

Alves emphasized that patient involvement is embedded in the drug development process because, by the time the product reaches patients, its quality is often insufficient. She said patients want to be enthusiastic about the new reforms but also want deep collaboration with other stakeholders in the drug development process, to participate in ground-level decision-making, and not to be sidelined.

Kieran Maher, associate director for global regulatory intelligence and policy at Alexion/AstraZeneca, provided the industry perspective and said there are still a lot of deficiencies in the legislation that he hopes can be addressed through upcoming implementation acts.

"One of the key things is on the application day when the regulation and directive come into force, we don't need to have everything perfect, but we do need to have a workable model," said Maher. "Some of the text isn't maybe where everybody would like it to be, but if we can probably coordinate through some of the meetings that have been highlighted, we can get to a workable solution that hopefully will deliver on the vision that is being presented."

Alberto Gañan Jimenez, head of committees and the quality assurance department at EMA, said they are finalizing the establishment of governance structures to implement the legislation, establishing different workstreams, and making prior decisions on what needs to be delivered by specific timelines.

"We have a huge challenge against us to implement this legislation, but we also have a huge opportunity," said Gañan Jimenez. "We have to bear in mind that we need to do it together.

"We will need to have experts to help us in implementing and also to drive the core work," he added.

Rebecca Lumsden, head of EU regulatory science and policy at Sanofi, moderated the panel and agreed with Gañan Jimenez.

"We are facing the biggest legislative change in our sector in 25 years, and we have to implement it while we're kind of flying the plane," she said. "And when I say we, I may mean you, but we will obviously be impacted."

When asked whether orphan products approved during the transition period could be converted to a breakthrough designation and then receive two bonus years of market exclusivity.

Rodiadis said the question doesn't just apply to orphan incentives but other incentives as well. He noted that the issue is covered by the transition provisions.