Euro Convergence: Regulators discuss new pharma legislation, AI, and more

A panel of European regulators answered questions during a town panel discussion at RAPS Euro Convergence 2026 on the implementation of the new EU Pharmaceutical Legislation and the use of artificial intelligence (AI) in regulatory and drug development.

Shorter review timelines

The EU has proposed significantly reducing drug evaluation timelines—to as little as 150 days for some products—in the recently proposed pharmaceutical legislation reform package, which is expected to be implemented in December pending sign off by the European Parliament and Council. (RELATED: Euro Convergence: EU pharmaceutical overhaul brings challenges, hope for better regulation, Regulatory Focus 11 May 2026)

"I would like to know, how do you want to manage that?" one attendee asked. "Do you intend to add resources … or if you're going to evaluate quicker, how's that going to work?"

Alberto Gañan Jimenez, head of committees and the quality assurance department at the European Medicines Agency (EMA), said the new legislation is an opportunity for regulators to rethink the way they operate and collaborate. He said they are looking into every provision and establishing the governance structures and groups that will be used for decentralized procedures.

Gañan Jimenez said that EMA and the Heads of Medicines Agencies are looking into the capabilities of the regulators within the European Medicines Regulatory Network to determine its capacity to undertake the work.

“We have many initiatives, especially training new assessors through an initiative called IncreaseNET, [and] preparing a curriculum for new assessors," said Gañan. "We are also now doing some activities ... where we are bringing assessors from the whole network to build bridges between themselves, between the different national competent authorities.

"[There is] a very big strategy on human resources to have a more holistic view of how we manage the capacity and the capabilities of the European Union network," he added. "We're already working a lot on it, and I hope that whenever we face that problem, which is to shorten timelines, we are quite ready and well-prepared."

Panel moderator Sabine Haubenreisser, principal scientific administrator for stakeholders and communication at EMA, noted that regulators are counting on industry to submit their dossiers on time. She also urged industry to keep reviewers informed if they are unable to meet their timelines.

"When we put together an assessment team in the various authorities, if then the dossier doesn't come, they are sort of blocked from doing something else," said Haubenreisser. "Also, submit a high-quality dossier.

"The better the quality of the dossier, the quicker the assessment can be," she added.

Marta Marcelino, head of regulatory strategy and innovation at Portugal's National Authority for Medicines and Health Products and chair of the Co-ordination Group for Mutual Recognition and Decentralized procedures - Human (CMDh), emphasized that shortening timelines does not mean reducing standards. She added that shorter timelines will be a shared responsibility and noted that regulators can stop the review within 90 days after validation if it is considered immature.

"It is also a bit up to you to help us achieve this very demanding task of giving a decision within 180 days," said Marcelino.

Marcelino pointed out that under the decentralized procedure, regulators can close procedures early, but that depends on the procedure moving smoothly. She also noted that there are many submissions they need to consider and allocate resources for on the national level.

"We are also increasing training at the level of the network and also ensuring that we try to focus more on the questions that are really needed for the assessment of the quality, safety, efficacy, and benefit-risk conclusions," said Marcelino. "This is also a process for us, and I think we are going in the right direction ... the procedures will have to adapt a bit like the centralized procedures."

Marcelino added that CMDh has not discussed how they plan to subtract the 30 days from their assessment calendar but noted that the time reductions will have to be split between the first- and second-phase evaluations.

"My key message is, let's all try to prepare better to make sure that we are able to reach this demanding task," she added.

"From the quality assessment point of view, I believe that the network is flexible enough to accommodate the shorter topics," said Ivica Malnar, senior pharmaceutical officer for documentation assessment at Croatia's Agency for Medicinal Products and Medical Devices. "I think we have quite a large network of quality, safety, and clinical assistants, and I believe that we can accommodate this."

Opt-in registration

An audience member also noted that under the proposed reforms, any member state can opt in to register a product from a company that has sought to register its product in another EU member state. They asked how that was possible, since the registration costs are borne by the company.

Marcelino noted that the opt-in was available for the Mutual Recognition Procedures (MRP) and the DCP.

"It is foreseen that if a member state considers that it needs that medicinal product to meet patient needs ... they can ask to become a [concerned member state]," said Marcelino. "Let's be very practical, this procedure is not expected to be used very often."

"Please look at the markets that you are intending to file your dossier," she added. "But also, please look at the possible needs of other member states that are not maybe in your general member state concerns."

Marcelino noted that a key objective of the new pharmaceutical legislation is to facilitate access and prevent drug shortages. She noted that the opt-in provision is intended as a security measure, allowing member states to signal to companies that they need a certain medication.

"According to the legislation, you are obliged to then submit the dossier to those member states and do all that is necessary," said Marcelino, though how that communication takes place is still being considered by the CMDh because they don't want to create undue administrative burdens.

"The intention is that we all have this responsibility of ensuring that all the patients of all the different member states have access to medicinal products," said Marcelino. "Try to look at markets that probably are not the ones that you immediately would consider, but maybe there are some [opportunities] that you can also take from this."

Audience member Rebecca Lumsden, head of EU regulatory science and policy at Sanofi, said the issue was concerning to industry. She asked whether concerned member states would accept single-language or single-country labeling when opting in to register a product, noting the challenge of creating labeling for individual countries.

"There is a cost associated with registering individual countries," said Lumsden. "You've got translations, you've got registrational procedures, local requirements."

Marcelino said it is already a possibility because the opt-in provision was based on a recommendation from the Executive Steering Group on Shortages and Safety of Medicinal Products on regulatory flexibilities. She added that it is already a possibility for some member states, including Portugal.

"I'm not sure that we all want to go in that direction, and maybe we can link this also to the electronic product information that one day will be a reality," said Marcelino.

Considering the challenges and delays the Medical Device Regulation (MDR) has faced, one attendee asked whether regulators were taking any actions to avoid similar pitfalls that have plagued MDR’s implementation. They also noted that there was initially a dearth of guidances that left industry in the dark.

Haubenreisser said EMA has already started adopting provisions expected under the Pharmaceutical Legislation, including developing a governance structure and engaging closely with stakeholders to ensure everyone is ready to go when the legislation is implemented.

Gañan Jimenez noted that the agency has also been in close contact with the European Commission regarding the guidance process and implementing acts to ensure alignment on those topics. He also noted that, unlike MDR, the pharmaceutical legislation doesn't include provisions that affect currently authorized products, full certification of notified bodies, or full certification of databases.

Marcelino noted that the new pharmaceutical legislation has an oversight structure and structural changes, such as how the committees operate, while ensuring the standards don't change.

"I think the medical device regulation had much more structural change than this one," she added. "This is like the natural continuity of making our life better, because we have all this experience of 25-30 years working together.

"It's like an evolution, and not so much a revolution," she added.

Another attendee asked how companies could obtain parallel over-the-counter (OTC) status alongside their marketing authorization.

Marcelino noted that granting OTC status upon receiving marketing authorization approval is a national issue and will remain so. She noted that there are different pharmaceutical clinical practices and pharmaceutical inputs to consider, and that CMDh had a task force that attempted to address the issue, which recommended that manufacturers assess the different member states and determine whether their products are viable in each market.

Artificial intelligence

An attendee asked the panelists whether AI was just a tool to improve existing processes or something that could fundamentally reshape the discovery, approval, and monitoring of pharmaceuticals. Frank Pétavy, senior methodology expert at EMA, said that AI is good at handling large amounts of information quickly, but it's not intended to be right all the time and may make mistakes. He said its successful use depends on the level of risk associated with the AI that users are willing to accept.

Pétavy said AI has the potential to revolutionize drug discovery due to its ability to search for "a needle in a haystack." Regarding use as a drug-monitoring tool, he noted that AI tools already monitor adverse events, and additional tools for the postmarket setting are being developed.

"There are also rare diseases where it is difficult to generate the same level of evidence [that you would] for treatments for diseases where you have more patients," said Pétavy. "Maybe AI can help us triage the type of evidence that we have and the standards that we have."

Gañan Jimenez added that EMA has published guidance on using AI in drug discovery and in non-clinical and clinical drug development. He noted that the agency has engaged with industry to understand its priorities. Within EMA, he noted that regulators are exploring where they can effectively use AI.

"More or less, we are trying to embed [AI] in all parts," said Gañan Jimenez. "On one hand, helping developers in their use through guidance, and also in our processes."