Euro Roundup: EMA seeks feedback on framework for incorporating patient views into regulatory decisions

RoundupsRoundups | 21 October 2021 |  By 

The European Medicines Agency (EMA) has reached a draft qualification opinion on a framework for incorporating patient views into regulatory decisions. The agency “generally endorsed” the proposed research framework and is now seeking feedback on its preliminary position.
CHMP officials adopted the opinion on IMI PREFER, an Innovative Medicines Initiative-funded “framework with points to consider when selecting methods for industry, regulators and health technology assessment bodies for how to use patient preferences as input in medical product decision making.” The developers submitted the framework to EMA and EUnetHTA for review.
EUnetHTA, the European health technology assessment network, and CHMP provided parallel scientific advice earlier this year, leading to a draft opinion that voiced support for the use of patient preference studies (PPS) to inform regulatory decision-making in “certain instances” while also identifying limitations of IMI PREFER.
“The framework shall however not be considered as equivalent to an EMA guideline or reflection paper. Regulatory experience with PPS is currently limited and therefore formal EMA guidance how PPS can be applied and should be performed to successfully support marketing authorisation applications cannot be given,” the draft opinion states.
CHMP sees “manifold” potential PPS applications “ranging from supporting the choice of endpoints for clinical studies to generating information on efficacy and safety trade-offs.” As such, any PPS, regardless of adherence to a framework, must be assessed “according to its objectives and specific use case.” EMA is encouraging sponsors to seek scientific advice at the study planning stage if PPS are to play an important part in their requests for marketing authorization.
EMA is accepting feedback until 25 November.
Draft Opinion, CHMP-EUnetHTA Advice
MHRA updates pharmacovigilance guidance for post-Brexit relationship with EU
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on pharmacovigilance procedures with new sections on how its system is affected by activities in the European Union.
MHRA published the first draft of the guidance late last year, shortly before the UK completed its split from the EU. The changes made last week represent the first major update to the text and bring clarity to the role of EU pharmacovigilance activities in the UK now that Brexit has given MHRA full responsibility for drug safety.
The first major change to the text relates to signal detection. In updating the guidance, MHRA has added a request that marketing authorization holders share signal assessment reports from EMA's Pharmacovigilance Risk Assessment Committee (PRAC) with it once the recommendation is available. MHRA also added details of how to handle new information.
“A new or changed risk that requires a change to the terms of the marketing authorization should in principle be the subject of an application for variation of the terms of marketing authorisation, unless the marketing authorisation holder considers that further analysis by the licensing authority is warranted. Further analysis by the MHRA may be sought on signals in the case of validated signals that cannot be refuted nor confirmed as new or changed risks,” the guidance states.
MHRA has also made significant changes to a section on Periodic Safety Update Reports (PSURs). The new guidance states what companies should do when an EU assessment triggers amendments to the product information. MHRA expects to receive a copy of the Heads of Medicines Agencies decision or Committee for Medicinal Products for Human Use (CHMP) opinion as soon as possible so it can factor the EU’s views into its own thinking and “avoid any unnecessary divergence.”
The guidance features additional advice on Post Authorization Safety Studies and how MHRA expects companies to implement the findings of EU referrals related to the studies, PSURs, signal assessments and Post-authorization Measures.
“For Great Britain-only MAs, the expectation is that you will follow EU outcomes and make the same changes to the Great Britain-only MA that are made to the corresponding EU MA. In order to do so you will need to submit the corresponding procedure to the MHRA,” the guidance states.
MHRA aims to contact marketing authorization holders within 14 days of the publication of an EU outcome if its assessment results in UK-specific requirements. The timeline may be delayed if the marketing authorization holder fails to provide MHRA with the data it needs to assess the situation.
MHRA Guidance
Finland adopts clinical trial legislation ahead of implementation of new EU regulations
The Parliament of Finland has adopted new legislation on clinical trials to align the law with incoming EU regulations. Most of the amendments will take effect at the same time as the EU Clinical Trials Regulation early next year.
Finnish politicians passed the law to enable national regulation of a range of topics, including certain conditions for trials involving vulnerable populations, principles of fees for sponsors and compensation paid to subjects and matters related to the supervision of clinical trials. The act also equips Finnish Medicines Agency (Fimea) to meet its responsibility to prepare assessment reports.
Other aspects of the legislation propose the establishment of a new National Committee on Medical Research Ethics. The proposed committee will assess the ethics of all clinical trials in Finland and draw up part of the assessment report stipulated by the incoming EU regulation.
Most of the amendments take effect on 31 January, the same day that the EU regulation comes into force. The exceptions are provisions for the processing of personal data. Those provisions will take effect before the EU regulation.
Fimea Notice
Denmark’s DKMA describes consultation procedure for devices that contain medicines
The Danish Medicines Agency (DKMA) has released details of the consultation procedure for medical devices containing medicinal substances.
When evaluating such devices, notified bodies must consult with DKMA or another EU Competent Authority. The consultations enable the verification of the quality, safety and usefulness of the medicinal substance. Notified bodies need to take the findings into account when reaching a decision on a medical device but retain the power to choose whether to certify the product.
DKMA has described the process notified bodies need to follow to seek its opinion on medicinal substances. The Danish regulator has prepared an application form and linked to EMA guidance on the dossier requirements. DKMA will charge notified bodies DKK 70,342 ($11,000) per device.
DKMA Notice
MHRA shares guidance on canceling EU licenses converted in Brexit transition process
MHRA has shared guidance on what to submit if a converted license is canceled in mainland UK this year. The guidance applies to centrally authorized products that were converted as part of the UK’s split from the EU.
To ease the Brexit process, MHRA automatically converted licenses and gave marketing authorization holders until the end of 2021 to file data on the affected products. The updated guidance explains that failure to provide the data on time will lead MHRA to cancel the license. Companies will need to file a new application at the normal cost and undergo a full assessment to regain market access.
If companies want to cancel licenses, MHRA is asking them to submit information including a cover letter and the Summary of Product Characteristics. MHRA wants the information to enable it to have a record of all licenses that were converted to national licenses for its database.
MHRA Guidance


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you