Euro Roundup: EDQM posts full guideline on mRNA vaccine batch testing

RoundupsRoundups | 08 April 2021 |  By 

The European Directorate for the Quality of Medicines (EDQM) has published its full guideline on the batch testing of mRNA vaccines against COVID-19, such as the shots from Moderna and Pfizer/BioNTech.
EDQM first released a guideline to support Official Control Authority Batch Release of mRNA vaccines against COVID-19 by Official Medicines Control Laboratory in November. The original text, which has been in force since its publication, stated laboratories should test the appearance, identity, potency and integrity of at least 30 single or multi-dose containers of each final lot of mRNA vaccines.
The final guideline reiterates the type of test laboratories should perform but reduces the number of containers that must be analyzed to 15 per final lot.
In the final guideline, EDQM explains the protocol submission process. EDQM expects manufacturers to make submissions that “reflect all appropriate production steps and controls for a particular product as outlined in the marketing authorization for that specific product.” EDQM has created a model protocol to help ensure complete and harmonized submissions.
EDQM’s model is intended to capture all appropriate production steps and controls, as required by the marketing authorizations, and the monographs that are relevant to the vaccines. The directorate is asking manufacturers to tailor its model to their marketing authorizations, adding and omitting items as needed.
“The essential point is that all relevant details demonstrating compliance with the marketing authorization and the Ph Eur monograph(s) (if available) for a particular product should be given in the protocol submitted,” the guideline states.
EDQM wants manufacturers to provide details of the test results, beyond whether they just passed or failed, and give sufficient detail to allow the re-calculation of test values. The directorate is also asking for the specifications and dates of all tests, as well as the results of qualification tests on each new in-house reference material. 
EDQM Notice

MHRA reiterates commitment to Early Access scheme amid pandemic

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has said the Early Access to Medicines Scheme (EAMS) is continuing as normal despite the disruption caused by the pandemic.
MHRA, like other regulators, has committed resources to the response to the COVID-19 crisis but this week moved to quell potential doubts about the effect of the pandemic on EAMS. The agency said the scheme “has remained fully operational” throughout the pandemic.
The UK regulator presented an early access case study involving Roche’s anti-PD-L1 checkpoint inhibitor Tecentriq in unresectable hepatocellular carcinoma (HCC). Many key steps in the EAMS process for Tecentriq happened during the pandemic.
MHRA issued a positive scientific opinion for Tecentriq through EAMS in June 2020. The European Commission granted a license to Tecentriq in November 2020. In the intervening months, 63 patients with HCC accessed Tecentriq because of the positive EAMS opinion.
“Raising awareness of EAMS, especially during the coronavirus pandemic is important to ensure patients with high unmet medical needs such as these HCC patients, do not miss out on potentially life-changing new treatments,” Gemma Boni, head of liver cancer at Roche, said.
MHRA Statement

EMA halves fees for anti-bioterror vaccines

The European Medicines Agency (EMA) has introduced a fee incentive for post-authorization filings for human vaccines cleared “under exceptional circumstances for preparedness against biological agents that might be used as weapons of bioterrorism.”
Companies that bring such vaccines to market will benefit from a 50% cut in the total applicable fee for a range of post-authorization applications. The incentives apply to the annual fee, type-IA, type-IB and type-II variations, and the renewal, extension and transfer of the marketing authorization.
EMA introduced the bioterrorism vaccine fee incentives in an explanatory note on the fees payable for different regulatory services. The latest version of the explanatory note also features a change to EMA’s position on pandemic post-authorization applications.
The agency previously applied a 100% reduction to most post-authorization activities related to the pandemic core dossier, the notable exception being the type-II pandemic variation. However, at that stage EMA said the reductions applied “at any time up to 5 years from the MAA validation date or the date of the Type II Commission Decision, whichever comes first.”
EMA removed the maximum period for the fee incentives in the latest version of the explanatory note. Now, the fee incentives apply “from the MAA validation date up to the date of the Type II Commission Decision.”
Fee Note

Finland creates new adverse events form, adapts to volume of COVID reports

The Finnish Medicines Agency (Fimea) has introduced an electronic adverse reaction reporting form. Fimea disclosed the form the day after revealing the volume of information on adverse events linked to COVID-19 vaccine had necessitated the restructuring of its website.
In a statement to introduce the new reporting form, Fimea expressed hopes that all notifications will be sent via the electronic channel. The new form uses the same authentication system Finland uses for other public administration services and is accessible by healthcare professionals and patients. All existing reporting forms remain available.
Fimea also used the statement to clarify when to report adverse reactions to COVID-19 vaccines. The agency only wants people to report unexpected and serious side effects. Adverse reactions covered by the summary of product characteristics do not need to be reported.
Separately, Fimea said it “has become necessary to clarify and develop the structure of COVID-19 related websites” because of the increasing amount of information on adverse reactions.
Fimea Notice (Finnish), More

EMA veterinary group clamps down on experts who miss multiple meetings

EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) has warned it may remove members of its safety working party who miss three consecutive meetings “without reasonable justification.”
CVMP disclosed the new policy in an update to the rules of the working party, which were revised last year but only added to EMA’s website this week. The older rules stated members need to attend regularly but lacked further information. Under the new rules, missing three meetings in a row will lead CVMP to either reconfirm the membership of the expert or nominate a new member.
The policy is necessary “given the restricted membership of the working party,” CVMP wrote. The updated document also features new rules on just how restricted membership is. Now, CVMP aims to have 10 to 12 experts that it has identified as having the required scientific expertise. The old rules allowed each member state to nominate one expert to sit on the working group.
CVMP Rules

Other news:

MHRA has issued an alert about adverse skin reactions linked to the Dexcom G6 continuous glucose monitoring system. The alert follows reports of users experiencing symptoms such as redness, swelling and blistering. MHRA said the barrier creams or patches some patients are using to reduce the reactions “could affect the way the sensor works.” MHRA Notice
The French National Agency for Medicines and Health Products Safety (ANSM) has released an alert about osteoporosis medications delivered via multidose pen. ANSM Notice (French)


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