Euro Roundup: EU Parliament adopts position on expanded EMA mandate

The European Parliament has adopted its position on extending the European Medicines Agency’s (EMA) mandate. Parliamentarians voted overwhelmingly in favor of a text that will shape upcoming negotiations with the European Council over the final legislation.
 
As part of an effort to build a health union, the European Commission adopted a legislative proposal on EMA’s mandate in November. The Commission proposed reinforcing EMA’s mandate to enable the agency to facilitate a coordinated European Union-level response to health crises by mitigating the risk of shortages of critical medicines and medical devices, providing scientific advice on products for use in responses to crises and coordinating studies including clinical trials.
 
With the Council agreeing its position last month, the adoption of Parliament’s stance was the last step before the start of negotiations. Parliament adopted its position last week by voting in favor of 152 amendments to the text proposed by the Commission.
 
The amendments include a proposal to set up a European medicines supply database (EUMSD). The Parliament sees EUMSD as a way to enable the monitoring of the supply, demand and shortages of medicinal products in the EU.
 
If enacted, the amendment would require each EU member state to set up an electronic platform for the real-time monitoring of the supply of medicinal products. The Parliament wants the platforms to be “capable of determining the volume of supply of each medicinal product existing at any given moment, and detecting, predicting and preventing shortages of medicinal products.” Member states will have 30 months from when the regulation comes into force to set up their platforms.
 
The amendment envisions the national databases being interoperable and replicating information in the EUMSD managed by EMA. ISO standards developed for the Identification of Medicinal Products will apply to data submitted to the database.
 
Other amendments include a proposed requirement for EMA’s activities to be covered by “robust transparency measures and standards” such as the timely publication of all relevant information on approved products and clinical data, including full clinical trial protocols. The Parliament wants EMA to apply a “high degree of transparency on the membership, recommendations, opinions and decisions of the newly established Steering Groups and the Emergency Task Force.”
 
The focus on transparency is reiterated in an amendment on public information about clinical trials and marketing authorization decisions. The amendment would require the publication of European public assessment reports within seven days of marketing authorization.
 
Press Release, Adopted Text
 
EMA shares guidance on COVID-19 vaccine periodic safety update reports
 
EMA has shared guidance on the additional information manufacturers need to include in periodic safety update reports (PSUR) about COVID-19 vaccines.
 
While no additional requirements apply to many sections of the PSUR, EMA has extensive guidance on the extra information companies need to include in other parts of their reports. The section on the evaluation of risks and new information is one area in which EMA is imposing extra requirements on COVID-19 vaccine manufacturers.
 
EMA is imposing additional requirements related to new information on other potential risks that are not categorized as important. Examples of such information include evidence of a lack of efficacy. EMA is advising companies “to take into account the incubation period and the normal delay for the protection to be acquired as a result of immunization and whether the occurrence of the disease has been confirmed by laboratory tests or not.” The text features definitions of confirmed and suspected vaccine failure. 
 
Another section of the guidance addresses how EMA wants companies to disclose post-approval requests from other regulatory agencies. The section states the approach to disclosure depends on whether the conclusion of the requested evaluation constitutes a valid signal.
 
EMA also used the guidance to remind manufacturers of COVID-19 vaccines that monthly summary safety reports are not meant to replace PSURs. As such, EMA expects all relevant information to be provided in the PSURs.
 
EMA Guidance
 
MHRA updates guidance on medical device stand-alone software
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on medical device stand-alone software. MHRA has added new information on the qualification of in vitro diagnostic (IVD) software and the process for determining if a product is a medical device.
 
In the section on determining the intended purpose of a product, MHRA has added a paragraph to clarify that the decision is influenced by factors other than manufacturer’s view of the device. The guidance now states MHRA or an averagely informed consumer may view a product as a medical device based on its labelling, instructions for use, promotional material and mode of action.
 
Elsewhere, MHRA has added a section to complement a flow diagram that is designed to determine if a product is a medical device or an IVD medical device. The additional information includes details of how manufacturers can assess if software is “substantially driven” by IVD data. MHRA’s guidance explains that “assessment of how an algorithm is 'driven' is complex as variables do not necessarily scale linearly with a simple weighting factor.”
 
MHRA Guidance
 
German regulator starts selling medicinal cannabis to pharmacies
 
Germany's Federal Institute for Drugs and Medical Devices (BfArM) has begun selling medicinal cannabis to pharmacies. BfArM is sourcing cannabis grown in Germany from three companies and selling it at cost.
 
Before BfArM became involved in the supply of medicinal cannabis, pharmacies had to import their supplies. Pharmacies can continue to source medicinal cannabis from outside of Germany but now also have the option to buy from BfArM for €4.30 ($5.10) per gram.
 
Pharmacies can source 2,600 kg of cannabis a year from BfArM. The German regulator has contracts in place to source that amount for four years to meet demand created by a 2017 change in the law on medical cannabis.
 
BfArM Notice (German)
 
Denmark, Finland and Sweden form pharmacovigilance and IT collaboration
 
Regulatory agencies in Denmark, Finland and Sweden have formed a long-term alliance covering the areas of pharmacovigilance and information technology. The collaboration is intended to help the three agencies meet their obligations under EU law.
 
The Finnish Medicines Agency (Fimea) identified the 2012 regulation on pharmacovigilance and 2018 regulation on veterinary medicinal products as the drivers of the alliance. Working with the Danish Medicines Agency and Swedish Medical Products Agency, Fimea will create a joint pharmacovigilance system to replace the “aging national solutions” in use in each country.
 
Fimea envisages the collaboration optimizing the use of resources and leading to the development of a system that improves the handling of adverse event reports. Specific objectives of the collaboration include better customer service, cost savings and improvements to the quality, accuracy and speed of signal detection and case management.
 
Fimea Notice
 
Other News:
 
Italy’s Kiwa Cermet Italia S.P.A. became the 21^st notified body designated under the Medical Device Regulation. European Commission, Press Release (Italian)
 
EMA has published a question and answer document on the submission of legacy data on veterinary medicinal products into the Union Product Database. The document is aimed at national competent authorities and is based on questions asked at webinars earlier this year. EMA Q&A
 
The European Directorate for the Quality of Medicines (EDQM) has published a monograph on the anti-TNF-alpha product golimumab for consultation. EDQM Notice