Euro Roundup: Swissmedic pilots fast-track procedure to accelerate clinical trial authorizations

Swissmedic has started a pilot project to evaluate the faster processing of certain clinical trial applications.

The agency said that, under certain conditions, applications for medicinal product clinical trials can be processed much faster than the current turnaround times. That knowledge led the agency to start a pilot project that is intended to promote innovation and ensure patients have faster access to new, potentially life-saving treatments by truncating the clinical trial application review process.

The pilot is open to medicines designed to address a high medical need because there is no authorized treatment option in Switzerland for the disease. Swissmedic will also fast-track applications for studies of “known investigational medicinal products.”

Officials will take 20 days to review applications, down from 30 days under the standard pathway. The agency will evaluate applications for first-in-human clinical trials in 40 days, compared to 60 days under the current system.

Swissmedic said the new turnaround times “clearly place Switzerland in the forefront compared to other countries.” The agency said a comparable procedure in the European Union “often takes more than 50 days.” Under the EU Clinical Trials Regulation, the two-part review process can run in parallel, with each part taking up to 45 days. The process is extended if requests for information or expert input are needed.

Swissmedic’s implementation of the fast-track pilot follows the adoption of legislation that will cut trial review times in the UK, a country that, like Switzerland, is in Europe but outside the EU. The new UK law gives the Medicines and Healthcare products Regulatory Agency (MHRA) seven days to validate applications and a further 30 days for review. The 30-day window includes regulatory and ethics review.

The new timelines take effect in the UK in April 2026. Swissmedic’s pilot project started this month and is scheduled to run until the end of 2026. The agency is adopting the fast-track process as a pilot because a legal amendment will be needed to establish a permanent procedure. Swissmedic said lawmakers will not be able to make the amendment until 2027 at the earliest.

“Until then, pharmaceutical companies, research and healthcare institutions will benefit from the shorter processing periods since it will enable clinical trials to be initiated more efficiently and innovative treatments to be made available sooner,” Swissmedic said.

Press Release

EMA seeks feedback on lessons learned from non-clinical COVID-19 research

The European Medicines Agency (EMA) has shared a draft reflection paper to assess what the pandemic revealed about how to improve the efficiency of non-clinical development and regulatory interactions.

Seeking to accelerate the development of COVID-19 treatments and vaccines, regulators deviated from non-clinical safety and efficacy guidelines at times in the pandemic when it was scientifically justified. EMA said it was possible to deviate from the standard rules without compromising patient safety, leading it to consider how the lessons learned can be applied in the future.

The resulting draft reflection paper focuses on “scientific considerations for pivotal, non-clinical data used to support clinical development and marketing authorization without jeopardising patient safety,” EMA said. The lessons are particularly relevant for potential future pandemic or emergency settings.

EMA said that, in general, deferring the evaluation of safety endpoints for drugs and vaccines until a later phase clinical development is not accepted. However, in the pandemic regulators allowed companies to use platform data or well-characterized precursor safety data to speed up clinical trial development. The approach used broad knowledge, such as mRNA safety data, to accelerate work on specific candidates.

Once products came to market, EMA found that “none of the novel, rare adverse reactions reported for SARS-CoV-2 vaccines were observed in, nor could have been anticipated based on, animal data.” Neither the use of platform data nor the timing of non-clinical data submission negatively affected clinical safety or the benefit/risk profile of a SARS-CoV-2 related vaccine, EMA said.

“The use of platform data to establish the safety profile of an emergency therapy is accepted from a regulatory perspective and allows for deferred submission of product-specific data,” EMA said. “For vaccines with well characterised platform data, repeat dose toxicity studies are not needed to support [first-in-human] studies.”

EMA is accepting feedback on the draft paper until 30 September.

Draft Paper

Swissmedic imposes new requirements on healthcare professional safety letters

Swissmedic has updated its guidance on direct healthcare professional communication (DHPC) to require companies to add the “red safety information” symbol to the materials.

From 1 July, the DHPCs that authorization holders send to healthcare professionals to communicate new safety information must carry the symbol on the envelope and, if applicable, the announcement. The symbol features an exclamation mark on a red background, plus text in a black box that states important safety information is being shared in consultation with Swissmedic.

The agency implemented the requirement to make a clear distinction between promotional materials and important safety information on medicinal product risks. The updated guidance establishes rules on the placement and size of the safety symbol.

Swissmedic mandated the use of the symbol as part of a guidance update that included changes to standardize the structure of a DHPC. The agency wants companies to use a standard title for DHPCs and include a statement to indicate that Swissmedic has endorsed the information.

Swissmedic Notice

EMA shares recommendations for human product master data implementation

The Network Data Steering Group (NDSG) has shared recommendations for how EMA can use product master data to facilitate efficient regulatory processes and decision-making.

EMA defines master data as “any non-transactional information considered to play a key role in the core operation of a business and re-used for multiple purposes.” EMA has services for centralized management of four types of master data. The product service covers harmonized data and definitions to uniquely identify a human medicinal product based on regulated information.

NDSG said product data is currently “entered via multiple submission points in several systems, triggering unnecessary complexity, suboptimal data quality, maintenance costs in the long run and an increased burden on the Network and stakeholders.” The problems, plus the opportunities provided by the pharma reforms, led NDSG to reassess regulatory processes and provide guiding principles for a new model.

The group said “product master data should be managed as an asset of the [European medicines regulatory network] to deliver benefits for medicines regulation, for innovation and for patients.” EMA and national authorities need “multi-year resource allocation” to realize the benefits of product master data, NDSG said.

NDSG Report

Other News:

EMA published the next steps for its push to use real-world evidence to support regulatory decisions. As part of a report about regulator-led studies run in the 12 months up to February 2025, the agency said its fourth and final wave of data partners will focus more on specific therapeutic areas of interest such as oncology. EMA also plans to explore the use of large data sources from outside of Europe. EMA Report

MHRA has told physicians to limit the use of fluoroquinolones to situations when other antibiotics, that are commonly recommended for the infection, are inappropriate. The recommendation follows a review that found fluoroquinolones such as ciprofloxacin can cause serious side effects that result in long-lasting or permanent disability. MHRA Report

Euro Roundup: Swissmedic pilots fast-track procedure to accelerate clinical trial authorizations

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