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Euro Roundup: EU launches survey for COVID-19 drug developers

Posted 17 June 2021 | By Nick Paul Taylor 

Euro Roundup: EU launches survey for COVID-19 drug developers

The EU is holding a survey to understand the needs of companies developing new and repurposed treatments for COVID-19. The follows the European Commission’s recent strategy to support the approval of up to five new COVID-19 drugs by the end of the year.
 
(RELATED: EC strategy aims for 3-5 new COVID therapeutics by year end, Regulatory Focus 6 May 2021)
 
In the survey, the EU asks for information about the COVID-19 therapies companies are developing, including the type of product, the stage of COVID-19 that it is designed to address and the stage of development it has reached. For candidates in clinical development, the EU wants additional information including the number of member states involved in the study and aspects of the enrollment criteria, such as whether children can participate.
 
The survey asks when developers expect to file for approval of their products, giving the EU access to information that will show whether the Commission’s end-of-year goal is feasible, and seeks details of the regulatory support they need. Respondents can select multiple types of support such as free scientific advice, fast-track clinical trial approvals and shortened market access procedures.
 
The survey also solicits information on COVID-19 drug developers’ manufacturing plans, such as whether they plan to outsource the work and whether they have already identified and booked capacity. Other questions address whether drug developers foresee any manufacturing bottlenecks, as well as whether they expect to have enough capacity to meet demand in the EU.
 
Respondents are also asked to provide information about the intellectual property (IP) statuses of their products. The EU is seeking to understand if companies face IP bottlenecks, such as litigation or disputes, and whether they would be willing to license their technology as part of development and production partnerships in the region. The EU has previously held a matchmaking event designed to put COVID-19 vaccine developers in contact with companies that have manufacturing capacity.
 
The survey is open until 25 June, but the EU wants to receive responses as soon as possible given the urgency of the COVID-19 situation. The Spanish Agency of Medicines and Medical Products (AEMPS) shared details of the survey this week.
 
EU Survey, AEMPS Notice (Spanish)
 
EDQM forms drug quality and safety pact with Eurasian Economic Commission
 
The European Directorate for the Quality of Medicines (EDQM) has formed a drug quality and safety agreement with the Eurasian Economic Commission (EEC), the permanent regulatory body of a bloc that includes Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia.
 
Through the memorandum of understanding, the two parties will exchange pharmacopoeial texts and materials from the Eurasian Economic Union Pharmacopoeia and the European Pharmacopoeia. The agreement also covers the exchange of regulatory and technical documentation, information on the development of pharmacopoeia and experience of the pharmacopoeial analysis of medicines.
 
There is also scope to implement other forms of cooperation on areas of mutual interest. EDQM sees a growing need for such cooperation between the EU and other countries and regional groupings.
 
“The climate in which we are living today, where the whole world is deeply affected by the COVID-19 pandemic, has made it exceedingly clear how crucial agreements such as this one are to fighting the pandemic. Only through international collaboration, co-operation and harmonization can solutions be found,” EDQM director Susanne Keitel said.
 
Press Release
 
Dutch MEB seeks feedback on plans to use pictograms on medicine labels
 
The Dutch Medicines Evaluation Board (MEB) is seeking feedback on a new policy covering the use of pictograms on the packaging of medicines.
 
Dutch officials indicated their interest in making greater use of pictograms on medicine packaging in 2018, when they held a public consultation on the topic. MEB said almost all of the 100 responses it received about adopting a pictogram on medicines that should not be used in pregnancy were positive, leading to the addition of such an icon to valproate packages later that year.
 
Now the valproate pregnancy warning, the first of its kind in the Netherlands, could be joined by more pictograms under the proposed changes to the MEB policy on the labeling of medicines for human use. The proposal includes an explanation of an approved pictogram set for use by marketing authorization holders. MEB has also added an annex featuring a list of standardized pictograms that it deems suitable for use on medicine packaging.
 
MEB Notice (Dutch)
 
Medtronic pulls advertising campaign after MHRA upholds complaint
 
Medtronic has put promotional campaigns involving the SynchroMed II pump on hold after the UK Medicines and Healthcare products Regulatory Agency (MHRA) upheld a complaint about promotion of the device.
 
The complaint centered on a LinkedIn advertisement about the use of a generic prescription-only medicine with Medtronic’s intrathecal injection device. As the ad was viewable by the public in November, a complainant said Medtronic was breaching the rules on the promotion of prescription medicines. The complaint also said linked pages were not clearly distinguished for healthcare professionals.
 
MHRA upheld the complaint. Medtronic responded by putting SynchroMed II pump promotions on hold and removing the LinkedIn campaign, including the linked webpages covered in the complaint. MHRA said Medtronic is reviewing patient webpages related to the SynchroMed II pump.
 
MHRA Notice
 
Commission releases Q&A on European Medical Device Nomenclature
 
The European Commission has published a question-and-answer document on the European Medical Device Nomenclature (EMDN). The Commission publication is a reformatted copy of the frequently asked question document released by the Medical Device Coordination Group (MDCG) last month.
 
Both documents start by defining EMDN, the nomenclature designed to support the registration of medical devices in EUDAMED and other features of the European database on medical devices. The Commission said the nomenclature also plays a key role in technical documents and other materials related to the Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR).
 
The documents set out eight principles that underpin EMDN. The principles include “regulator-led,” a term that is interpreted as meaning regulators must play a key role in managing, validating, updating and advising on the nomenclature.
 
Other sections of the documents address how companies can access EMDN. The nomenclature is freely available in PDF and Excel formats on EU websites. Making EMDN available for free is intended to support its use by stakeholders including manufacturers, patients, research organizations, practitioners, hospitals and pharmacies.
 
Commission Document, MDCG FAQ
 
Other News:
 
Belgian and Dutch authorities have advised against the release of Johnson & Johnson’s COVID-19 vaccine over worries about contamination at the Emergent Biosolutions’ plant that made the active substance. The active substance in the vaccines shipped to the EU is not thought to be affected by the cross-contamination. However, the authorities have recommended against releasing the vaccine as a precaution. The refusal to use 17 million doses will cause J&J to miss its delivery goal for the quarter. EMA Notice, Reuters
 
The Swiss Agency for Therapeutic Products (Swissmedic) has published a new form for clinical trial applications. The form applies to authorization applications and filings about changes, notifications and reports. Starting 13 September, companies will need to use the new form and a new folder structure to submit the applications. Swissmedic Notice

 

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