Euro Roundup: Swissmedic publishes questions and answers on submitting applications and documents for clinical trials

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The Swiss Institute for Therapeutic Products (Swissmedic) has published a Q&A document on submitting applications and documents for clinical trials. Swissmedic created the text to complement its guidance on the new submission process.

In the Q&A, Swissmedic briefly answers 13 questions about electronic submissions for conducting clinical trials in Switzerland. The agency’s responses explain that submissions cannot be made by email or, as of late last year, by a file transfer service. Swissmedic will return submissions sent by e-mail without processing.

Electronic submissions can be sent by post, with Swissmedic accepting copies of the required documents on CD or DVD together with a hand-signed paper form of its confirmation of the electronic submission text. The electronic submission confirmation form cannot be digitally signed and Swissmedic does not accept applications sent on USB sticks.

Paper submissions are still possible, provided the applicant sends complete paper documentation and a CD or DVD with the application materials. The system is still evolving. Although Swissmedic does not currently accept submissions via a portal, it is working to add this option.

Swissmedic asks applicants to use the “eDoc” folder structure, a template of which is available on its website in a ZIP file, to submit their submissions. The questions and answers explain where in the template the confirmation of electronic submission, including its final page signed and manually scanned, should be filed.

If proponents receive notification of a formal deficiency, they must respond by selecting the “RESPONSE to formal deficiency” submission type. Swissmedic would like sponsors to mention the service number, also called SA number, if it appears in the formal defect letter. However, in some circumstances the sponsor will not know the number and may leave the SA number field blank.

Update from Swissmedic

Turkey prepares new appeal tactic to break impasse in WTO trade dispute with EU

Turkey is set to deploy a seldom-used mechanism to appeal a World Trade Organization (WTO) ruling in its trade dispute with the European Union, saying the panel “erred in interpretation and application” of the rules.

The EU filed a lawsuit against Turkey in 2019 on the grounds that it was forcing foreign companies to relocate pharmaceutical manufacturing to the country. The panel set up to decide the case released its final report privately late last year, then went on to suspend its work indefinitely in March to allow time to complete the appellate arbitration.

According to Reuters, “the WTO’s highest appeals chamber has ceased to function due to a policy by former US President Donald Trump’s administration to block the appointment of new judges.” Faced with the stalemate, Turkey opted for an appeals approach that has been used once in the past 27 years.

In doing so, Turkey revealed the details of the findings of the WTO panel. The panel concluded that Turkey’s location requirement was inconsistent with the WTO’s General Agreement on Tariffs and Trade 1994. Turkey is appealing the finding.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) commented on the situation, reiterating its support for “an open and rules-based trading system that best supports the resilience and efficiency of global pharmaceutical supply chains” and the desire of its members to work with the Turkish government “to build an ecosystem that allows innovative medicines to benefit Turkish patients”. EFPIA expressed support for the panel’s findings.

“The conclusions reached by the group ensure non-discriminatory treatment of EU pharmaceutical exports to Turkey and continued access of Turkish patients to innovative and effective medicines, regardless of where they are manufactured. EFPIA will study the details of the report and we take note of the parties’ decision to resort to appellate arbitration,” the trade group wrote in a statement.

Filing with WTO, Reuters, EFPIA statement

Denmark raises regulatory fees for the first time since 2017 to fund IT investments

The Danish Medicines Agency (DKMA) has raised its fees for the first time since 2017, to help fund the DKK 34 million ($4.8 million) a year to update its IT systems.

“We need to replace old IT systems with new and better solutions, including IT solutions that can integrate with the systems used by other drug regulatory authorities in Europe. We rely on these IT systems and databases to perform our statutory tasks at the standard and speed expected by society,” said Lars Bo Nielsen, Managing Director of DKMA.

Nielsen acknowledged that DKMA is asking companies to pay more after a period in which the focus on COVID-19 impacted review times in other areas. The disruption continues, with DKMA saying finding ways to “effectively manage the backlog that is piling up” is one of its top priorities. DKMA is hiring staff, but it takes time to bring them up to speed.

DKMA Notice

Swissmedic updates guidance on authorization and labeling of COVID products

Swissmedic has updated its advice on the authorization and labeling of COVID-19 products, adding new comments on the languages ​​in which to submit patient information and the acceptability of QR codes.

Some of the updates concern Swissmedic’s guidelines on authorization procedures for COVID-19 products during the pandemic. The guidelines now state that patient information must be submitted in the official Swiss languages ​​and that, for applications in accelerated or temporary authorization procedures, applications must be made for pandemic drugs.

The regulator has also updated its Q&A on packaging and labeling requirements for medicines intended to prevent or combat COVID-19, changing answers to questions about the acceptability of EU packaging and patient information in English and adding a new section on QR codes. Swissmedic will not allow patient information to be made available only via a QR code, as some people will not be able to access the information.

Swissmedic Reviews, More

EDQM publishes batch release guidance for inactivated COVID vaccines

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a guideline on partial batch release for inactivated COVID-19 vaccines.

Valneva is working to bring an inactivated COVID-19 vaccine to market in Europe, aiming for conditional MA this quarter if its latest responses to questions from the Committee for Medicinal Products for Human Use are accepted. The EDQM guideline covers the list of tests that Official Medicines Control Laboratories (OMCLs) should perform as part of the batch release process.

The EDQM published the test list before completing the rest of the guideline to allow OMCLs and manufacturers to take the necessary steps for batch release and in doing so avoid availability delays while guaranteeing quality and safety. A comprehensive guideline including protocol templates is planned for publication at a later date to provide a codified framework for continuous batch release.

The text is the EDQM’s fourth batch release guidance for COVID-19 vaccines.

EDQM Notice

© 2022 Society of Regulatory Affairs Professionals.

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