Euro Roundup: EMA shares strategy for implementing ICH M12 drug interaction study guideline

The European Medicines Agency (EMA) has published specific considerations to enable stakeholders, including marketing authorization applicants and holders, to implement an international drug interaction study guideline.

EMA’s document addresses the International Council for Harmonisation (ICH) M12 guideline. The text came into effect in November and superseded an EMA guideline on investigating drug interactions that had been in force since 2013. While M12 has replaced the EMA text, the new guideline does not cover some topics to the same extent as its predecessor because the ICH considered them out of scope.

To address the gap, certain parts of the EMA guideline will continue to apply until the agency replaces the document, most likely with a question-and-answer text.

For now, marketing authorization applicants and holders, contract research organizations, and regulators should refer to the M12 implementation strategy to see which parts of the old guideline still apply. The implementation strategy features a list of topics that are still covered by the guideline and accompanying page and section references to the old document.

The guideline still covers ten topics, including food effects, contraceptives, and special populations, particularly children. Companies running drug interaction studies that involve one of the 10 topics should refer to the old guideline.

EMA also said it will withdraw seven questions from its question-and-answer document on clinical pharmacology because they are addressed in M12. The questions, which form the entire drug interaction section of the Q&A, address specific topics such as alternatives to the recommended 72-hour incubation time for enzyme induction or down-regulation in in vitro studies.

EMA Strategy

Industry pushes EU to become full member of MDSAP

MedTech Europe and COCIR have called for the EU to seek full membership in the Medical Device Single Audit Program (MDSAP).

The trade groups medtech and imaging companies said full membership will enable the recognition of MDSAP certificates for the CE marking of medical devices and in vitro diagnostics. The EU is currently an official observer of the program. The five full members, which include the US Food and Drug Administration (FDA), accept MDSAP audit reports as a substitute for routine agency inspections.

MedTech Europe and COCIR said full membership will reinforce the EU’s leadership in international medical device standards by enhancing global regulatory harmonization. The trade groups also see full membership as a way to reduce regulatory complexity and time to market by streamlining audits and cutting the administrative burden of multi-jurisdictional audits.

Reducing administrative burdens will foster competitiveness, especially for small companies, and enhance European businesses’ ability to fight for a share of global markets, according to the trade groups.

“By becoming a full member, the EU would reinforce its standing as a reference jurisdiction and facilitate greater recognition and reliance on CE marking,” they wrote. “This would reinforce the trust in the CE marking system and support the competitiveness of EU companies in the global market.

A “streamlined approach reduces the duplication of efforts and administrative burden associated with multiple separate audits,” the trade groups said. “With the reduced redundancy in audits, [notified bodies] can better allocate their resources, reduce costs and increase predictability, leading to more efficient use of auditors.” Most MDSAP auditing organizations are EU notified bodies, the trade groups said.

Reflection Paper

Swissmedic finds compliance problems with two-thirds of higher-risk legacy devices

The Swiss Agency for Therapeutic Products (Swissmedic) has found non-conformities with 20 of 30 high-risk legacy devices that it evaluated in a focused compliance campaign.

Under the Swiss Medical Devices Ordinance, manufacturers must establish a system for postmarket surveillance (PMS) and take other steps to monitor the safety of their products once they are on the market. Swissmedic assessed compliance with the requirements by looking at a sample of 30 legacy devices in risk classes IIa and higher, 28 of which were sold by foreign manufacturers.

Swissmedic saw 85 non-conformities with requirements related to the PMS plan system and safety report. PMS system non-conformities were the most common problem. Swissmedic found 11 products lacked a PMS plan or had a plan that failed to fulfill the requirements. For eight products, the safety report was not prepared according to the plan.

“The review demonstrates that while they are responsible for preparing the post-market surveillance documentation, not all manufacturers of higher-risk legacy devices are adequately implementing these requirements,” Swissmedic said.

Manufacturers are taking corrective actions in response to the findings. Swissmedic will follow up with the companies and impose additional measures as needed. The agency is asking all manufacturers to review their PMS processes and documents to ensure they are meeting the requirements.

Swissmedic Notice

Expert panel advises notified body to require additional data on surgical mesh device

An EU expert panel has identified a need for more data on a surgical mesh device after assessing a notified body’s evaluation of the product.

The panel assessed the notified body’s clinical evaluation assessment report as part of the conformity assessment of the high-risk device. The panel found the notified body conducted a comprehensive assessment of the manufacturer’s report but also highlighted a need for more data.

“The expert panel recognizes improvements in follow-up durations as recommended and noted the inclusion of real-world evidence and interim study reports,” the panel said. “However, it is emphasized that additional long-term data is necessary, and comparative studies would be beneficial to confirm the safety and performance of Phasix mesh in prophylactic use.”

The panel said the manufacturer should gather additional safety and performance on the device in the newly added prophylactic indication. The evidence should include data from registries and comparative data with other devices and surgical methods and cover at least five years of follow-up, the panel said.

Expert Opinion

Other news

Ireland’s Health Products Regulatory Authority (HPRA) has updated its application process for medical device certificates of free sale. Applicants can now use one form for all certificate of free sale requests. HPRA has also provided a new Excel device schedule, where the applicant should list all devices to be included on the certificate and update the information to be included on a template. HPRA Notice

Swissmedic has updated its portal. The update introduced a process for ordering good practice certificates and gave all pre-registered company administrators direct access to the portal. Swissmedic listed the lack of a new onboarding process for companies or administrators as a known issue with the portal. Swissmedic Notice

Euro Roundup: EMA shares strategy for implementing ICH M12 drug interaction study guideline

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