Euro Roundup: Swissmedic reorganizes to clarify medical device and market surveillance responsibilities

The Swiss Agency for Therapeutic Products (Swissmedic) has adopted a new organizational structure to make “responsibilities for medical devices and market surveillance clearer.”

Swissmedic committed to “making legal responsibilities for medical devices more visible and stepping up international collaboration in this area” in its 2023 to 2026 strategic plan. The priorities reflect the belief that there has been little harmonization of medical device regulations, despite it being a global industry dominated by companies with operations around the world.

The Swiss regulatory agency outlined its thinking on the medical device industry to contextualize its reorganization. Swissmedic created the Medical Devices Surveillance Sector through the reorganization. Like its predecessor the Market Surveillance Sector, the new unit is responsible for the safety of clinical trials, materiovigilance and market monitoring of medical devices. Other tasks performed by the new unit include monitoring the maintenance and processing of medical devices in hospitals.

With the new unit handling medical devices, Swissmedic is reassigning market surveillance for medicinal products to other units. The Medicinal Product Licences and Surveillance Sector is responsible for official licenses and inspections of clinical trials, plus the manufacture and distribution of medicinal products. The sector’s responsibilities now extend to market monitoring of authorized medicinal products.

Swissmedic has tasked the renamed Medicinal Product Authorisation and Vigilance Sector with handling the authorization of medicinal products, including vaccines, pharmacovigilance and “implementing the required safety-relevant corrective actions.” The agency has appointed Eveline Trachsel, who worked at Bristol Myers Squibb from 2015 to 2023, to lead the unit. Trachsel succeeds Claus Bolte, who stepped down in the middle of last year.

Swissmedic Notice

Targeting antimicrobial resistance, EMA seeks feedback on plans for phage guideline

The European Medicines Agency (EMA) has released a draft concept paper for consultation on the development and manufacture of phage therapies. EMA is seeking feedback on plans to create a guideline about a class of therapies that could help address the rise of antibiotic resistance.

Phage therapy is built on bacteriophages, viruses that infect and replicate in bacterial cells. Research into the use of phages to treat bacterial infections dates back 100 years but interest in the approach declined, in the West at least, as antibiotics became widely available in the 1940s. Now, with bacteria developing resistance to antibiotics, interest in phage therapy is increasing.

Currently, EMA lacks guidance to support developers of phage therapies for human use, although it does have a document on veterinary medicinal products. EMA has identified the lack of “distinct regulatory and scientific guidance throughout the life-cycle” as an explanation for why “the number of clinical trials investigating phage therapy products is fairly limited,” and there is one nationally authorized product.

The problem is that a “relative paucity of clinical and manufacturing experience with the phage therapy products” has meant developing a scientific guideline “has for a long time not been considered feasible.” EMA plans to solve the problem by “clarifying the quality requirements and therefore minimizing the regulatory and scientific gap to innovators addressing the problem of antimicrobial resistance.”

EMA’s draft concept paper lists goals for the guideline, such as creating phage-specific terminology and addressing the quality requirements for investigational bacteriophage products. The agency will collect feedback on the draft until the end of March, after which it will prepare a draft guideline for a six-month consultation.

Concept Paper

MDCG shares guidance on when devices are exempt from MDR clinical trial requirements

The Medical Device Coordination Group (MDCG) has published guidance to clarify when medical devices are exempt from requirements to undergo clinical investigation imposed by the recent regulations.

Under the Medical Device Regulation (MDR), manufacturers must put implantable and class III products through clinical investigations unless certain conditions are met. MDR lists four specific cases in which a medical device is exempt from the clinical trial requirement. MDCG has created the guideline to clarify the interpretation of the rules on exemptions.

One key clarification is that “the criteria outlined in one paragraph do not apply to the other paragraphs unless directly referenced.” That means the requirement for two manufacturers to have a contract “that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis” only applies to one of the four justifications for exemptions. Manufacturers without such contracts can still claim exemption if they fulfill the requirements of one of the other three justifications.

A contract can provide full access to the data a manufacturer needs to show its product is equivalent to an existing device, and therefore exempt from the clinical trial requirement, but “other means of access to data can prove to be adequate to support demonstrations of equivalence,” MDCG wrote. A section of the guidance covers how to show “sufficient levels of access to the data” to justify equivalence claims.

“It should also be noted that a higher level of access to data does not directly correlate to a stronger demonstration of equivalence,” MDCG wrote. “If a manufacturer is not able to demonstrate sufficient levels of access to the data needed for the demonstration of equivalence, equivalence claims cannot be made for the purpose of conformity assessment.”

MDCG Guidance

Swissmedic simplifies parallel imports to reduce costs for marketing authorization holders

Swissmedic has revised regulations on the therapeutic product notification procedure to simplify parallel imports. The changes are intended to reduce the cost of importing medicines authorized by Swissmedic from countries with “comparable medicinal product control.”

In 2022, the Swiss Parliament approved a change to the Therapeutic Products Act that supported the simplification of the parallel import process. Swissmedic responded by making changes to its ordinance that came into force on 1 January. The changes are intended to reduce the costs of parallel imports for marketing authorization holders without compromising patient safety.

Previously, companies that imported medicinal products needed to repack the products, taking them out of their foreign packaging and putting them in materials specific to Switzerland. The revisions eliminate that requirement. Now, companies can affix a label with the required Swiss information to the foreign pack. Similarly, the Swiss package leaflet can be enclosed without removing the original foreign leaflet.

Swissmedic Notice

EMA adopts ICH guideline on viral safety evaluation, sets June 2024 enforcement date

EMA has adopted an International Council for Harmonisation (ICH) guideline on evaluating the viral safety of biotechnology products. The updated ICH Q5A guideline provides additional recommendations on approaches to control the potential viral contamination of biotechnology products.

In 2022, EMA and other organizations sought feedback on plans to update the guideline, which dates back to the late 1990s. The process resulted in a final guideline that features new information on established and complementary approaches to controlling viral contamination and the data that should be submitted in marketing authorization applications to show the viral safety of biotechnology products.

“The risk of viral contamination is a concern for all biotechnology products derived from cell lines and needs to be reduced because such contamination could have serious clinical consequences. This risk can arise from the contamination of the source cell lines themselves (cell substrates) or from exogenous introduction of adventitious virus during production,” ICH wrote in the guideline.

The guideline will take effect in the European Union on 14 June.

ICH Guideline

Other news:

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has begun accepting submissions via its International Recognition Procedure (IRP). Using IRP, companies can leverage reports from certain reference regulators to benefit from shorter reviews at MHRA. IRP has replaced the EC Decision Reliance Procedure. MHRA Notice

Euro Roundup: Swissmedic reorganizes to clarify medical device and market surveillance responsibilities

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