Euro Roundup: MHRA outlines potential impact of AI on medical products regulation

The UK Medicines and Healthcare products Regulatory Agency (MHRA) views artificial intelligence (AI) from three perspectives: as a regulator of AI products, as a public service organization delivering time-critical decisions, and as an organization that makes public-safety and patient-safety decisions that are sometimes based on third-party evidence. That’s according to a policy paper on the impact of AI on medical product regulation published on 30 April.

“Many AI products, currently in the lowest risk classification meaning they can be placed on the market without an independent assessment of conformity, will be up-classified,” MHRA said. “This will protect users and patients through greater scrutiny throughout the product lifecycle.”

MHRA currently has three full-time equivalent staffers (FTEs) working on AI as a medical device workstream and plans to have a total of 7.5 FTEs in its 2024 to 2025 reporting period. MHRA is receiving Department of Health and Social Care AI Lab funding for AI Airlock, a regulatory sandbox that will soon begin pilot use.

The report discusses the potential for AI to make MHRA more efficient. The agency is exploring the use of supervised machine learning to help assessors check applications for completeness, consistency and quality of the documents and to identify gaps, errors or discrepancies. The machine learning tool would provide a score or recommendation for each criterion or standard.

“This application would reduce the need for human involvement in these early assessment stages, enabling human expertise to be better targeted to make the critical assessment of whether the benefits of the product outweigh the risks,” MHRA said. The agency has 12 potential use cases to start prototyping technologies such as generative AI.

In the final section, MHRA said many uses of AI by the companies it regulates will not impact its work. However, the agency said AI may accelerate the pace of drug development and “it is also likely to impact on clinical trial design and is an enabler of personalized medicines.”

The MHRA paper comes in response to the UK government's commitment to making AI regulation more “agile” and providing agencies with money to “develop cutting-edge research and practical tools to monitor and address risks and opportunities in their sector.”

Policy Paper, Press Release

EMA shares guidance on sampling excipients at high risk of glycol contamination

The European Medicines Agency (EMA) has added questions about excipients at high risk of diethylene glycol (DEG) and ethylene glycol (EG) contamination to its guidance on good manufacturing and distribution practices.

In answers to seven questions, EMA explained the background of DEG and EG contamination, the regulatory documents that cover European patients and specific details of manufacturer responsibilities.

EMA clarified that “sampling of only a portion of containers would not normally be possible.” While an annex to the manufacturing rules allows relaxation of identity testing of every container, it only applies if brokers or intermediates are not involved in the chain of supply. Glycerol and other excipients tend to have long, complex supply chains that involve brokers.

Another response describes the steps manufacturers and importers should take when buying excipients at high risk of contamination. Companies “should be able to exhibit a good knowledge of the supply chains and apply this knowledge and principles of quality risk management to their programs for supply-chain management,” EMA said. Inspectors will assess a company’s approach to the supply chain.

EMA discussed the European Pharmacopoeia Commission (EPC) DEG/EG limit test and acknowledged that it may be difficult to perform on large numbers of containers because it involves a gas chromatographic method. Alternative tests are under consideration, EMA said, but the existing test remains the official method for confirmation of compliance with the monograph. The requirements apply to approved products.

“The excipients are required to comply with the current European Pharmacopoeia monograph, and as the specification approved in the dossier will have been that of the European Pharmacopoeia, the risk of DEG/EG contamination will have been appropriately controlled,” EMA said. “Compliance with this requirement can be verified during GMP inspections.”

EMA Q&A

EDQM seeks feedback on cell-based therapies, shares update on gene therapies

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is conducting a consultation into a proposed framework of requirements for the production and control of cell-based preparations.

Officials at the European Pharmacopoeia Commission (EPC) have proposed a new general chapter on cell-based preparations for human use to meet the need for information about the quality of a rapidly evolving subset of advanced therapy medicinal products. When it shared its priorities for 2023 to 2025, EPC identified the work on cell therapies as one of a number of “significant projects” targeting biologicals.

The resulting draft text includes a definition of cell-based preparations and “an extensive set of general requirements common to all” such products, EDQM said. EPC has also proposed “four detailed individual sections” that outline additional requirements that are specific to four cell types.

EDQM shared news of the consultation alongside an update on gene transfer medicinal products. EPC adopted a gene therapy general monograph and general chapter at a meeting in March to replace a text it first published in 2006. EDQM called the new approach “an important milestone on the path towards a standardized way of controlling” gene therapies.

The general monograph sets out provisions on the production of all gene therapies, as well as specific requirements for genetically modified human autologous cells, adeno-associated virus vectors and oncolytic herpes simplex virus. EPC has included information on product classes that are not yet on the European market in the general chapter.

EDQM said the monograph provides a common framework of requirements “while offering the level of built-in flexibility judged necessary for these products, given the rapidly evolving nature of the field.”

EDQM Notice, More

EMA forms pact to exchange confidential medicine information with Korean agency

EMA has signed up to exchange confidential information on medical and medicinal products with Korea’s Ministry of Food and Drug Safety (MFDS).

The two parties began sharing information on products used to diagnose, prevent and treat COVID-19 and related infectious diseases during the pandemic. That ad-hoc arrangement laid the foundation for a formal confidentiality agreement that leaders from EMA and MFDS signed last week.

The new working arrangement covers the exchange of information related to activities such as licensing, benefit-risk assessments and inspections. Sharing information could help the agencies ensure the safety, efficacy and quality of the products they regulate.

EMA called the agreement “an important step towards mutual recognition and regulatory harmonization to improve human and animal health.” The agreement is valid for an indefinite period and does not need renewing.

Press Release, Working Arrangement

Other news:

EMA’s Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target JN.1 in the 2024 to 2025 vaccination campaign. ETF published the recommendation days after the World Health Organization (WHO) adopted the same position. JN.1 emerged quickly late last year and WHO expects it to form the basis for further evolutions of SARS-CoV-2. EMA Notice

Euro Roundup: MHRA outlines potential impact of AI on medical products regulation

Related topics

Recommended content

Welcome to the new RAPS Digital Experience