Euro Roundup: Commission seeks feedback on proposed EudraVigilance changes

RoundupsRoundups | 02 September 2021 |  By 

The European Commission is seeking input on planned changes to pharmacovigilance regulations. Based on feedback from the European Medicines Agency (EMA), the Commission is proposing to add rules about EudraVigilance monitoring and contracts with pharmacovigilance service providers.
Overall, the Commission said the experience with the pharmacovigilance implementing regulation is “good.” However, talks with EMA and the Pharmacovigilance Risk Assessment Committee have identified the need for “targeted amendments” that reflect the experience gained since the adoption of the regulation in 2012.
The proposed changes affect five sections of the regulation. The Commission is planning to require that marketing authorization holders (MAHs) that subcontract pharmacovigilance activities include “a description of the process in place to ensure third parties are in compliance.” The proposal reflects frequent inspection findings related to contracts with third parties
Another planned change will require MAHs to monitor EudraVigilance “in a manner proportionate to the risk, together with other available data sources,” rather than just “to the extent that they have access to that database.” The Commission plans to delete a section on what MAHs should do when they detect a signal, reflecting its belief validation should be left to regulatory authorities.
Other changes include updates to the latest standards from the International Organization for Standardization and changes to the wording of text about the transmission of suspected adverse reactions. The text will no longer use the term “expedited reporting.”
Finally, the Commission is proposing to request that MAHs register postauthorization safety studies in the repository maintained by EMA and submit an abstract of the results within one month of the finalization of the study report. The Commission has suggested that study protocols that contain confidential information are either redacted or kept private until the study is finalized.
The Commission is accepting feedback until 15 October.
Commission Notice, Consultation Document
Sanofi withdraws valproate website after complaint triggers MHRA investigation
Sanofi has withdrawn a website on sodium valproate aimed at healthcare professionals after a member of the public complained to the UK Medicines and Healthcare products Regulatory Agency (MHRA). MHRA concluded the website was “appropriately targeted”, but Sanofi decided to pull the material.
Valproate, a treatment for epilepsy and bipolar disorder that Sanofi sells as Epilim, has been the focus of regulatory scrutiny in the EU in recent years as authorities have sought to mitigate the risk of birth defects and developmental disorders in children born to those who took the medicine while pregnant. The Coordination Group for Mutual Recognition and Decentralised Procedures - Human adopted a strengthened regulatory position to ensure patients are fully aware of the risks in 2018.
MHRA said a member of the public did not consider the patient viewpoint to be “adequately considered” in the material on Sanofi’s Valproate Knowledge Centre website. The complainant also “questioned the suitability of the format” and raised concerns that clinical data was used selectively, focusing on effectiveness rather than presenting a balanced picture of the risks faced by people of childbearing age. The complainant said the public could easily access doctors only content.
After reviewing the website, MHRA concluded it was “appropriately targeted towards an audience of healthcare professionals” but still communicated the concerns to Sanofi. MHRA asked Sanofi to ensure the website “was brought up to date with the latest information to support safe use of valproate.”
Rather than revise the website, Sanofi withdrew it entirely “as the relevant safety materials are available on alternative appropriate digital platforms,” MHRA said. MHRA took no further action but reminded Sanofi of the need to keep information up to date.
The UK regulator released details of the case alongside information about other advertising reviews it has completed in recent months. The other cases include a complaint by ALK, a manufacturer of allergy immunotherapies, against Diagenics, a distributor of allergy tests and treatments. ALK said Diagenics shared a price list for unlicensed medicines to healthcare professionals in breach of rules on promotion. MHRA upheld the complaint and Diagenics removed potentially promotional content.        
MHRA Notice, More
EMA probes possible link between inflammatory condition and COVID vaccine
EMA is collaborating with its Danish counterpart to investigate a severe inflammatory condition that affected a 17-year-old recipient of Comirnaty, the Pfizer/BioNTech COVID-19 vaccine.
Five days after receiving the second dose of the vaccine, the young man developed multisystem inflammatory syndrome in children (MIS-C). The condition is characterized by a very strong immune reaction that causes inflammation of the organs. At one point the condition of the young man was life-threatening; after treatment, he is now in good health. EMA and the Danish Medicines Agency (DKMA) want to understand what happened.
MIS-C is a known complication of COVID-19, affecting an estimated 1 in 4,000 infected children. However, the young man had not been infected with COVID-19. No causal link to the vaccine has been found but DKMA cannot rule out a rare side effect at this stage. DKMA has said patients who develop symptoms such as diarrhea and vomiting need to be referred.
Even if the vaccine is identified as the cause of MIS-C, the risks posed by the vaccine appear to be far less than the dangers of COVID-19. In Denmark alone, 300,000 12- to 19-year-olds are fully vaccinated against COVID-19. If MIS-C was as common after vaccination as it is following COVID-19 infection, far more cases would likely have been seen around the world in recipients of Comirnaty.
DKMA Notice, More
EDQM updates guidance for electronic submission of CEP applications
The European Directorate for the Quality of Medicines (EDQM) has updated its guidance on making electronic applications for Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs).
EDQM updated the guidance to reflect the current practices for submissions, which must use the electronic Common Technical Document (eCTD) format. The new guidance explains it is mandatory to include any previously assessed and approved information from the “baseline (full dossier)” when switching to eCTD from another format. EDQM is imposing the requirement, which will take effect in January 2022, to facilitate the lifecycle management of the dossier.
If files or sections of the eCTD contain a lot of information, EDQM recommends the use of additional bookmarks or “levels of granularity” to facilitate the review. EDQM sees value in using bookmarks in response to deficiency letters.
Other changes include clarifications to subjects including the submission of grouped revisions and the addition of examples of format issues that may hinder the receipt of applications. EDQM made the changes based on feedback from applicants.
EDQM Notice
Other news:
MHRA has appointed non-executive directors from the Bill & Melinda Gates Foundation, Microsoft and other organizations to its board. The four new directors took up their posts on 1 September, replacing predecessors whose terms had come to an end. Non-executive directors lack voting rights but provide additional breadth of experience to the board. MHRA Notice
The Finnish Medicines Agency (Fimea) has stopped accepting paper notices regarding veterinary medicinal product clinical trials. Fimea moved to a fully email based system on 1 September. Fimea will send acknowledgements of notification submissions that include a number for use in all correspondence related to the case. Fimea Notice (Finnish)


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