Regulatory Focus™ > News Articles > 2022 > 3 > Euro Roundup: EC cleared to negotiate international pandemic treaty

Posted 10 March 2022 | By Nick Paul Taylor 

Euro Roundup: EC cleared to negotiate international pandemic treaty

3016 The European Council has authorized the European Commission to negotiate an international agreement on the prevention, preparedness and response to pandemics. By 2024, European authorities hope to have in place an instrument that equips the world to accelerate detection of and response to pandemics.
European officials publicly floated the idea of an international treaty on pandemics late in 2020 and the Council adopted a decision to support the launch of negotiations in May 2021. An intergovernmental negotiating body is set to meet in August and report to the World Health Assembly in 2023.
The details of the agreement are the subject of the planned negotiations, but the EU has spoken in broad terms about what it wants to achieve.
“A globally coordinated approach to discovering, developing and delivering effective and safe medical solutions, such as vaccines, medicines, diagnostics and protective equipment would benefit collective health security,” the Council wrote. “The sharing of pathogens, biological samples and genomic data as well as the development of timely medical solutions (vaccines, treatments and diagnostics) are vital in order to enhance global pandemic preparedness.”
The Council also has identified a need for global supply chains and logistics systems to “be more resilient to cope with global health threats.” Officials would like the agreement to support “global coordination for effective stockpiling” and the “ability to deploy medical equipment and highly-skilled international medical teams on the ground.”
Press Release
Denmark warns crisis in Ukraine may impact drug approval review times
The Danish Medicines Agency (DKMA) has warned that the conflict in Ukraine may affect the prioritization of cases and its ability to meet the review times for many medicine application.
“The situation in Ukraine may influence our ability to meet our review times for applications for marketing authorisations, variations and renewals as well as applications for parallel import. The reason is that medicines that are going to be more needed during the current crisis will be dealt with first – especially applications deciding if a medicine can be marketed,” DKMA wrote.
DKMA’s leaders said they are doing “all we can” to ensure applications are reviewed within the agreed time limits but the situation may prevent them from always hitting their targets. Pharma companies that believe the review of their application “is decisive for the medicine to be marketed” can email DKMA to discuss their cases.
DKMA Notice
Spain, Switzerland outline rules on donating medicines to Ukraine
The Spanish and Swiss drug regulatory agencies have warned private individuals against directly donating medicines to Ukraine, urging them instead to go via recognized aid organizations to ensure distribution rules are met.
The Swiss Agency for Therapeutic Products (Swissmedic) issued its notice after getting “a lot of questions on how medicinal products can be exported to the conflict area.” Swissmedic said monetary donations to established aid agencies are the “best and fastest way” to get medicinal products to people in Ukraine. The products need to meet the safety, effectiveness and quality standards applied to all medicines.
“It is therefore vital that they come from controlled sources and are correctly stored and transported (cold chain, sterility, etc.), and that the recipient is able to handle them properly. The export of medicinal products therefore requires an export license to ensure the safety of these products,” Swissmedic wrote.
The Spanish Agency of Medicines and Medical Products (AEMPS) issued a similar notice. AEMPS pointed to World Health Organization recommendations to make the case that donations need to go through the appropriate channels.
Swissmedic Notice, AEMPS Notice (Spanish)
EDQM posts batch release guideline on recombinant protein COVID-19 vaccines
The European Directorate for the Quality of Medicines (EDQM) has published the full guideline on the batch release of recombinant spike protein COVID-19 vaccines.
EDQM initially focused on the development of full batch release guidelines for mRNA and viral vector vaccines, reflecting the fact that the frontrunner products by AstraZeneca, Johnson & Johnson, Moderna and Pfizer-BioNTech used the technologies. With Novavax’s protein-based vaccine now authorized for use in the EU, and a Sanofi-GlaxoSmithKline candidate following close behind, EDQM has put out its full Official Control Authority Batch Release guideline on recombinant protein COVID-19 vaccines.
The directorate published part of the guideline in April. EDQM updated the guideline in November but at that stage the text still only featured an introduction and a description of the samples that should be supplied to the Official Medicines Control Laboratory performing batch release and the tests the facility should perform.
In expanding the guideline, EDQM has added a section about the submission by the manufacturer of a protocol reflecting all the appropriate production steps and controls for the product. The section is identical to the equivalent part of the guideline on mRNA COVID-19 vaccines.
There are differences between the tests that need to be run, though. The differences in tests reflect the differences in the technologies used in the vaccines. For example, the recombinant protein guideline lacks the mRNA and lipid nanoparticle tests in the guideline that applies to vaccines made by Moderna and Pfizer.
EDQM Notice
France doubles mandatory stockpiles of 422 medicines
The French National Agency for Medicines and Health Products Safety (ANSM) has increased the minimum stockpile of 422 medicinal products of major therapeutic interest (MITMs) to four months.
Last year, France began requiring the suppliers of certain medicines to always have at least two months of stock, to ensure medicines of major therapeutic interest remain on the market despite supply disruptions. After reviewing the situation, ANSM has doubled the minimum stockpile for around 14% of the MITMs covered by the law.
ANSM has the power to increase the minimum stockpile if there have been regular stockouts, or risks of stockouts, over the past two years of a MITM that is deemed to be of particular importance. Recent additions to the list of products with four-month stock requirements include a seizure treatment sold by Sandoz. Products from companies including GlaxoSmithKline, Pfizer and Sanofi were added late last year.
ANSM is giving the affected companies six months to set up the stockpile. The agency next plans to review the list in 2023, when it will factor what happened in 2021 and 2022 into its decision. ANSM has also allowed the manufacturers of 98 products to carry stockpiles of less than two months. AbbVie’s Duodopa and Johnson & Johnson’s Darzalex feature on a list dominated by products of human origin.
ANSM Notice (French)
Other news:
Swissmedic has updated its information sheet on the unique identification numbers it assigns to Swiss manufacturers, authorized representatives and importers of medical devices. The agency called the update an “extensive revision” of the document, first published late in 2020, that changes its structure and name while adding “additional relevant information.” Swissmedic Notice


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