Euro Roundup: Swissmedic revises four medicines authorization guidances

The Swiss Agency for Therapeutic Products (Swissmedic) has updated four guidance documents related to its procedures for authorizations, variations and extensions.

Three of the documents address specific aspects of the authorization of human medicines. Swissmedic has revised a document about time limits for authorization applications by adding details of international Project Orbis and Access Consortium procedures. Project Orbis and Access Consortium are initiatives in which Swissmedic collaborates with international peers on the authorization of medicines.

Swissmedic has added a subsection about the international procedures, in which it explains that special time limits apply “so that the partner authorities involved are able to meet their national legal obligations and performance standards.” The agency has listed the limits in an annex and restructured its overview to organize procedures by standard, fast-track, and national and international procedures.

The agency has also updated its guidance on meetings for applicants for authorization procedures. As part of the update, Swissmedic has introduced a Preliminary Decision Clarification Meeting as a pilot. Applicants can request meetings to ask questions and seek clarification about Swissmedic’s preliminary decisions.

Swissmedic is offering clarification meetings related to applications for new authorization or variation of the indication of medicinal products for human use with a new active substance. Applicants that used a fast-track procedure, sought temporary authorization, and filed via Access Consortium or Project Orbis are among the companies that can request meetings. There are limits on what can be discussed.

“New data will not be accepted as part of the Preliminary Decision Clarification Meeting and no assessment of the content of new aspects will take place,” Swissmedic said. “Aspects that still need to be discussed with partner authorities are excluded from the discussion in international procedures.”

Another of the updated documents covers temporary authorizations. Swissmedic can grant temporary authorizations to medicinal products that identify, prevent or treat diseases that can cause disability or threaten lives. The agency is extending the scope of the procedure to allow the temporary authorization of human medicinal products with a known active substance.

“The restriction that the innovative aspect of the new authorization with known active substance must be an indication extension has been removed from the scope,” Swissmedic said. Swissmedic previously updated the guidance to allow temporary new authorizations of known active substances but limited the pathway to new indications.

The fourth revised document addresses variations and extensions. The agency has updated the text to simplify the rules on issuing new packaging codes and eliminate subsumption of fees for multiple applications.

As a result of the simplification, Swissmedic expects to issue significantly fewer new codes in the future. The changes to fees follow the decisions to increase the flat fee for indication extensions to 25,000 Swiss francs ($28,000) and lower the maximum cost cap to 30,000 Swiss francs. Those changes informed Swissmedic’s decision not to subsume fees for multiple applications.

All four of the updated documents took effect on 1 June.

Time Limits, Meetings, Temporary Authorizations, Variations

EMA publishes 2023 annual report, showing fading effect of COVID-19

The European Medicines Agency (EMA) has published the annual report covering its activities in 2023. The report shows the normalization of EMA’s workload as the pandemic eased, with multiple metrics of activity falling back to levels last seen before the crisis began.

EMA contended with increased demand for its services during the pandemic. The development of drugs and vaccines against COVID-19 contributed to a jump in requests for scientific advice. The number of requests climbed 17% in 2020 and rose again to peak at 853 in 2021. Last year, the number of requests fell to 692, the lowest level since 2019, as the number of requests related to COVID-19 dropped to 28.

A similar, but more extreme, pattern is evident in EMA’s analysis of adverse event reports. The number of adverse drug reaction reports for centrally authorized products sent from in the European Economic Area fell to around 500,000 last year. The figure is less than half of the number of reports sent in 2022, which itself was down slightly in 2021, when activity peaked at above 1.5 million reports.

The origin of the reports has changed too, with the share of reports submitted by European patients and consumers falling “considerably” compared to 2021 and 2022. The 2023 share is more in line with pre-pandemic figures.

“The considerably higher rates of ADR reports, including from patient reporting, during the pandemic were a result of the mass vaccination campaigns and the heightened awareness of the importance of reporting any suspected side effects,” EMA said.

Annual Report

EMA updates frequently asked questions about parallel distribution

EMA has updated its advice about parallel distribution, adding a new query to its frequently asked question document and updating its responses to several existing inquiries.

The new question asks about the requirements for dormant notices. In its response, EMA explains that a product should be updated to the “dormant” status if it has not been distributed in parallel for the last 12 months. There is no fee for changing the status. Distributors do not need to submit annual updates when a product is dormant. An application and annual update must be filed to reintroduce a product.

“The product can then be distributed in parallel once again, from the day of status update in IRIS, provided that the Agency has been made aware of the changes which have occurred since the product was dormant through the annual update procedure,” EMA said.

EMA also updated its response to three questions about the procedures of parallel distribution, where to find the latest published marketing authorizations and what is an annual update.

FAQ

Northern Ireland approves requirements on dispensing valproate

Politicians in Northern Ireland have approved regulations that will impose requirements on how the epilepsy and bipolar disorder drug valproate is distributed.

Children exposed to valproate in the womb can develop congenital malformations and neurodevelopmental disorders. Last year, the UK Medicines & Healthcare products Regulatory Agency published guidance about the need to dispense valproate-containing medicines in the manufacturer’s original full pack. Politicians are moving to establish the same requirements in Northern Ireland.

“The aim of the amendment is to require manufacturers' original full packaging dispensing of those medicines and to further decrease the number of babies who are exposed to valproate in pregnancy,” Mike Nesbitt, a politician in Northern Ireland, said at a debate about the regulations.

Pharmacists will be able to make an exception to whole pack dispensing on an individual patient basis, provided they have a risk assessment that addresses the need for different packaging and processes to ensure the supply of patient information leaflets.

Debate Transcript

Other News:

EMA has recommended conditional marketing authorization of Pfizer’s hemophilia B gene therapy Durveqtix (fidanacogene elaparvovec). The recommendation moves Pfizer a step closer to selling a gene therapy designed to deliver a functional copy of a variant of human factor IX transgene. The expressed factor IX replaces the coagulation factor IX that is missing in hemophilia B patients to enable blood clotting. Press Release

EMA has provided educational materials to reduce the risk of confusion with dosing requirements for the diabetes medicine Awiqli (basal insulin icodec). The materials are intended to counter the potential for confusion with other insulin pens. EMA Notice

Euro Roundup: Swissmedic revises four medicines authorization guidances

Related topics

Recommended content

Welcome to the new RAPS Digital Experience