Euro Roundup: Joint HMA-EMA group starts consultation into priorities for AI in research and regulation

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are running a survey to inform research priorities for the use of artificial intelligence in the development and evaluation of medicines.

The joint HMA-EMA Network Data Steering Group (NDSG) has asked European regulators, people in the pharma industry, and other stakeholders for feedback on research to support the safe and effective use of AI in medicine. With the opportunities and risks of AI affecting multiple areas, NDSG is seeking insights to help identify the most pressing topics for research.

NDSG is asking respondents to rate how important seven domains are for research on AI use in medicine development and evaluation. The list of domains includes regulation and oversight, which NDSG defines as “accountability and liability frameworks, best practices and guidance, and applicability of current laws and rules to AI tools.”

There are regulatory angles to the other domains. NDSG defines the data governance, confidentiality, and consent domain as “secure, lawful, and ethical handling of patient and user data, including consent and privacy protections.”

As well as asking respondents to rank the importance of each domain, the steering group has requested details of which two or three areas stakeholders would prioritize for research if resources were limited. NDSG also wants to know if any topics are missing from its survey. The steering group plans to share the findings with the research community.

NDSG is accepting responses until 17 October.

EMA Notice, Stakeholder Survey

EMA seeks feedback on disease-specific draft trial guidelines, concept papers

EMA has released two draft guidelines and a draft concept paper on the clinical development of drugs in three therapeutic areas.

EMA’s draft guidelines are updates to existing texts on developing treatments for chronic hepatitis B and psoriatic arthritis. The agency published the current hepatitis B guideline in 2006. EMA wants to update its advice to reflect efforts to develop functional cures for people infected by the virus, leading officials to propose changes to its position on primary endpoints.

The draft psoriatic arthritis guideline is intended to replace a document that came into effect in 2007. Because clinical practice has changed since then, EMA has proposed revising its advice about trial design, populations, and endpoints to reflect the currently available treatment options. Both draft guidelines are open for feedback until 31 March.

EMA released the proposed guidelines alongside a draft concept paper on the clinical investigation of drugs to treat idiopathic pulmonary fibrosis (IPF). The agency is yet to publish scientific guidance on IPF trials and said such a text would facilitate development and support marketing authorization filings.

The draft concept paper includes an outline of the topics EMA intends to cover in the planned guidelines on IPF. EMA has proposed covering topics such as the relevance and limitations of commonly used outcome measures, the choice of comparator, and the number of pivotal trials needed to support filings for approval. Officials are accepting feedback until the end of 2025.

Hepatitis B, Psoriatic Arthritis, IPF

MHRA posts guidance on filing to run UK clinical trials that include in vitro diagnostics

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on filing an application for approval of a clinical trial that includes an in vitro diagnostic (IVD) device.

Per the guidance, sponsors can use IVDs to stratify patients in clinical trials of medicinal products. The test results can either inform whether a person is eligible to participate in the study or determine which cohort they will join.

When running trials in Great Britain, sponsors can use IVDs that have a UKCA or CE mark for use as intended by the manufacturer in a clinical trial. Alternatively, a health institution exempted device may be used if the IVD is manufactured and used within the same health institution.

Sponsors with IVDs that lack either a UKCA, CE mark, or exemption should run an analytical performance study before using the test in the study. Where no analytical performance study has yet been conducted, the characteristics of the IVD must be studied and described in a tabular summary, MHRA said.

The regulatory status of the IVD determines the process for applying to run the trial. MHRA has asked applicants to disclose the use of an IVD in their covering letters. Either the covering letter or the protocol should confirm compliance with any applicable CE-marking requirements.

If using a UKCA or CE-marked device, the applicant should file a confirmation that identifies the device manufacturer, their UK responsible person, and MHRA device registration. MHRA wants applicants to use “a company letterhead” when submitting confirmations. Other requirements apply to companies that use a health institution exempted device, have analytical data, or rely on a tabular summary.

MHRA Guidance

European Council calls for immediate action to simplify regulations

The European Council has called for immediate action to address “a complex regulatory framework” that it has identified as a problem for the life sciences industry.

Calling for the European Union to have a leading role in life sciences, the Council has asked the European Commission to work with Member States on “actions to overcome administrative barriers and simplify regulations.” The Council, which defines the general political direction of the EU, named regulation as a contributor to the attractiveness of the region for innovation and manufacturing.

The Council has called on the Commission “to assess the regulatory challenges that the use of research results and innovative life sciences companies encounter on their way to market, and to propose appropriate measures to overcome these in the forthcoming European Innovation Act, as part of the wider initiative to reduce regulatory burden.”

Clinical trials and health data are specific concerns. The Council said the use of health data for research and innovation is a major challenge, adding that better coordination of existing initiatives will be a first step toward addressing data-related regulatory problems.

Press Release

EDQM shares advice on when products should be available with or without a prescription

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published guidelines on how to evaluate whether a medicinal product should require a prescription.

EDQM created the guidelines to help national competent authorities, marketing authorization holders, and other interested parties to classify medicinal products. The guidelines introduce a new approach that the Committee of Experts on the Classification of Medicines as Regards their Supply has adopted.

“The characteristics of the active substance and pharmaceutical form, the therapeutic indications, and the safety profile are considered, as well as the extent to which healthcare professionals’ expertise is needed to diagnose and treat the condition for which the medicinal product is to be used,” EDQM said. “The nature and degree of any potential risk of misuse or incorrect use are also considered.”

EDQM Notice

Other News:

The Swiss Agency for Therapeutic Products (Swissmedic) has definitively introduced preliminary decision clarification meetings after piloting the concept. Swissmedic began the pilot last year to assess the value of giving applicants an additional chance to seek clarification of concerns the agency raises in preliminary decisions. Updated guidance on the meetings took effect this week. Swissmedic Notice

The European Commission has carried out unannounced antitrust inspections of a vaccine manufacturer. Sanofi later confirmed that it was the target of the inspections. The Commission took the steps because of concerns that the company may have violated antitrust rules that ban the abuse of dominant market positions, specifically in relation to possible exclusionary practices. Press Release, Financial Times

The UK has given pharma companies another four weeks to decide whether to leave the 2024 voluntary scheme for branded medicines pricing, access, and growth (VPAG). Companies now have until 31 October to decide. Drugmakers that do not give notice by the end of the month must stay in the program for all of 2026. The change comes weeks after talks about the VPAG rate collapsed. Press Release

Euro Roundup: Joint HMA-EMA group starts consultation into priorities for AI in research and regulation

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