Euro Roundup: UK consultation finds support for retaining EU medtech laws

The UK government is planning to retain four EU medical device laws after a consultation found support for the proposal.

As part of the Brexit process, any retained EU legislation that had not been revoked by the end of 2023 was assimilated into the law in Great Britain. The assimilated laws included four pieces of medical device legislation that cover the common technical specifications for in vitro diagnostics, electronic instructions for use, products that use tissues of animal origin, and the designation of approved bodies.

With the four laws set to expire on 26 May, the Medicines and Healthcare products Regulatory Agency (MHRA) started a consultation late last year to gather views on the government’s proposal to retain them. The government said the retentions, which would affect England, Wales, and Scotland, but not Northern Ireland, would avoid disruption to the regulatory framework and ensure continuity for manufacturers.

MHRA received 287 responses, 56% of which were sent by businesses. The consultation found 83% of respondents agreed with the proposal; only 5% disagreed.

“The vast majority of those comments expressed general agreement with the proposal, with a significant number of respondents citing the importance of continuity in regulation for patient safety,” the government said. “Some respondents believed that, longer-term, the four EU regulations should be updated, but that maintaining them in the short term was the most sensible approach.”

Now the government plans to amend the Medical Devices Regulations 2002 to revoke the sunset date of the four pieces of EU law. The action is intended to “avoid creating a gap in regulation that could have serious patient safety implications” and reflects MHRA’s view that the laws “form an effective and vital part of the UK’s regulatory framework for medical devices,” the government said.

A small number of respondents said guidance would be beneficial and called for clarification of the government’s policy on electronic instructions for use of medical devices. MHRA is preparing legislation that will replace a domestic law on electronic instructions for use. Over time, the agency plans to replace the assimilated EU laws.

Government Response

Swissmedic sets timeline for bringing ICH good clinical practice guideline into effect

The Swiss Agency for Therapeutic Products (Swissmedic) is planning to start bringing an international guideline on good clinical practices (GCPs) into effect this summer.

Last month, the International Council for Harmonisation (ICH) adopted a harmonized guideline on GCPs. The E6(R3) guideline, which replaces a document adopted in 2016, is split in two. Annex 1 covers how to apply GCP principles to interventional clinical trials. Annex 2 covers novel designs such as pragmatic and decentralized clinical trials, as well as studies that use real-world data.

Swissmedic plans to implement Annex 1 this summer. This timeline aligns with that of the European Medicines Agency (EMA), which will implement the first annex in July. Swissmedic said Annex 2 will be adopted later and will come into effect no earlier than the start of 2026 in Switzerland or the EU. EMA plans to adopt Annex 2 in mid-2025.

Swissmedic framed the updated ICH guideline to address the increasing complexity of clinical trials. The need for a more comprehensive revision to reflect the new complexity was evident when the second version of the guideline was adopted in 2016, Swissmedic said, “due to the growing complexity of trial designs, the increased use of new technologies, the greater volume of digital data and the increasing involvement of external service providers in the conduct of clinical trials.”

Swissmedic Notice

EMA shares considerations for implementing ICH guideline on solid oral dosage forms

EMA has published information to support implementation of an ICH guideline on the bioequivalence of immediate-release solid oral dosage forms.

EMA adopted the ICH M13A guideline in July and implemented it last month. The ICH text supersedes parts of an EMA bioequivalence guideline but only covers some of the topics addressed in the older document. ICH is planning a series of guidelines to address scientific and technical aspects of bioequivalence study design and data analysis. EMA expects those ICH texts to replace its guideline.

Until further ICH guidance comes into force, parts of the EMA document will apply in the EU. EMA said the requirements of the ICH guideline and its document may be applicable in situations including studies of highly variable drugs. Companies will need to justify deviations from either the ICH or EMA texts.

EMA is reviewing its product-specific bioequivalence guidance to determine whether the documents are compatible with the ICH guideline. Pending changes to the guidance, companies need to read the product-specific documents alongside the EMA and ICH guidelines and justify deviations from the texts.

EMA Document

Biologics Working Party updates advice on excipients, closure systems, and more

EMA’s Biologics Working Party has updated a question-and-answer document, adding information on excipients and closure systems and revising its response to an existing inquiry.

The new information clarifies that suppliers of rubber stoppers and glass cartridges for sterile finished products should be named in the common technical document. Where nitrogen is used for headspace gas, the element should be included in the finished product composition as a footnote, EMA said. The agency also explained where in the dossier to include justifications based on prior knowledge.

EMA revised its answer to a question about when low endotoxin recovery should be investigated. The updated response provides more information on how to perform the studies, the handling of quality control samples, and the need to focus on the finished product as it is administered to the patient.

EMA Q&A

EMA posts advice on how to spot scams, warns citizens against making payments

EMA has shared advice to help citizens spot scams that use its credentials after learning illegal third parties have asked people for money.

The agency updated a Q&A to explain that it will “never ask citizens for payment of any sort” and created a page to help people recognize scams. EMA is advising citizens to “be vigilant for fake invoices, emails or phone calls impersonating EMA and requesting money transfers.” Scammers may use EMA credentials such as its logo and names of members of its staff, the agency said.

EMA Notice, Q&A

Euro Roundup: UK consultation finds support for retaining EU medtech laws

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