Euro Roundup: Swissmedic posts Q&A on filing applications, documents for clinical trials

RoundupsRoundups | 05 May 2022 |  By 

The Swiss Agency for Therapeutic Products (Swissmedic) has released a question-and-answer document covering the submission of applications and documents for clinical trials. Swissmedic created the text to complement its guidance on the new submission process.
In the Q&A, Swissmedic provides short answers to 13 questions about making electronic submissions to run clinical trials in Switzerland. The agency’s responses explain that submissions cannot be made via email or, as of the end of last year, a file transfer service. Swissmedic will return emailed submissions unprocessed.
Electronic submissions can be sent by post, with Swissmedic accepting copies of the required documents on CD or DVD alongside a manually signed paper form of its confirmation of electronic submission text. The electronic submission confirmation form cannot be signed digitally, and Swissmedic will not accept applications sent on USB sticks.
Paper-based submissions are still possible, provided the applicant sends complete paper documentation and a CD or DVD with the application documents. The system is still evolving. While Swissmedic currently does not accept submissions via a portal, it is working to add that option.
Swissmedic is asking applicants to use the "eDoc" folder structure, a template for which is available on its website in a ZIP file, to send their submissions. The Q&A explains where in the template the confirmation of electronic submission, including its manually signed and scanned final page, needs to be filed.
If sponsors receive notice of a formal deficiency, they should reply by selecting the Submission Type “ANSWER to FORMAL DEFICIENCY”. Swissmedic wants sponsors to include the service number, also known as the SA number, if it is shown in the letter concerning the formal deficiency. However, in certain circumstances the sponsor will not know the number and can leave the SA number field blank.
Swissmedic Update
Turkey plots novel appeal tactic to clear logjam in WTO trade dispute with EU
Turkey is set to deploy a rarely used mechanism to appeal a World Trade Organization (WTO) ruling in its trade dispute with the European Union in the belief the panel “erred in the interpretation and application” of the rules.
The EU began proceedings 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 rule on the case delivered its final report in private late last year, and then followed up by suspending its work indefinitely in March to allow time for the completion of the appeal arbitration.
According to Reuters, “the WTO's top appeals chamber has ceased to function due to a policy of the administration of former US President Donald Trump to block new judge appointments.” Faced with the logjam, Turkey has opted for an appeal approach that has been used once in the past 27 years.
In doing so, Turkey has revealed details of the conclusions of the WTO panel. The panel found Turkey’s localization requirement is inconsistent with WTO’s General Agreement on Tariffs and Trade 1994. Turkey is appealing the conclusion.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) commented on the situation, reiterating its support for “an open and rules-based trading system which 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 enabling innovative medicines to benefit Turkish patients.” EFPIA voiced support for the conclusions of the panel.
“The conclusions reached by the Panel ensure non-discriminatory treatment of EU pharmaceutical exports to Turkey and continued access for Turkish patients to innovative and effective medicines, irrespective of the place of their manufacturing. EFPIA will study the details of the report and we take note of the decision of the parties to resort to appeal arbitration,” the trade group wrote in a statement.
WTO Filing, Reuters, EFPIA Statement
Denmark raises regulatory fees for first time since 2017 to fund IT investments
The Danish Medicines Agency (DKMA) has increased its fees for the first time since 2017, in order to help fund the  DKK 34 million ($4.8 million) a year in needs  to update its computer systems.
“We need to replace old computerized systems with new and better solutions—including IT solutions that can integrate with the systems used by the other drug regulatory authorities in Europe. We rely on these IT systems and databases to complete our statutory tasks at a standard and speed expected by society,” Lars Bo Nielsen, director-general of DKMA, said.
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 is still happening, with DKMA saying that finding ways to “deal effectively with the administrative work that has been piling up” is one of its top priorities. DKMA is taking on staff, but it takes time to get them up to speed.
DKMA Notice
Swissmedic updates advice on authorization and labeling of COVID products
Swissmedic updated its advice on the authorization and labeling of COVID-19 products, adding new comments about the languages to submit patient information in and the acceptability of QR codes.
Some of the updates affect Swissmedic’s guidance on authorization procedures for COVID-19 products during the pandemic. The guidance now states patient information must be submitted in the official Swiss languages and that, for applications in fast-track or temporary authorization procedures, requests must be made for pandemic medicinal products.
The regulator also updated its Q&A on the packaging and labeling requirements for medicinal products intended to prevent or combat COVID-19, amending responses to questions about the acceptability of EU packaging and English-language patient information and adding a new section on QR codes. Swissmedic will not allow patient information to be made solely available via a QR code as some people will be unable to access the information.
Swissmedic Notice, More
EDQM posts batch release guideline for inactivated COVID vaccines
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a partial batch release guideline for inactivated COVID-19 vaccines.
Valneva is working to bring an inactivated COVID-19 vaccine to market in Europe, targeting a conditional marketing authorization this quarter if its latest responses to the Committee for Medicinal Products for Human Use’s questions are accepted. The EDQM guideline covers the list of tests that Official Medicines Control Laboratories (OMCLs) need to run as part of the batch release process.
EDQM has released the list of tests before completing the rest of the guideline to allow OMCLs and manufacturers to take the necessary steps for batch release and, in doing so, prevent delays in availability while still ensuring quality and safety. A full guideline including model protocols is set for publication at a later date to provide a codified framework for ongoing batch release.
The text is EDQM’s fourth guideline on batch release for COVID-19 vaccines.
EDQM Notice


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