Home Framework Euro Roundup: EMA seeks feedback on framework for integrating patient perspectives into regulatory decisions

Euro Roundup: EMA seeks feedback on framework for integrating patient perspectives into regulatory decisions


The European Medicines Agency (EMA) has come up with a draft qualification opinion on a framework for integrating patients’ views into regulatory decisions. The agency has “generally approved” the proposed research framework and is now seeking comments on its preliminary position.

CHMP officials adopted the opinion on IMI PREFER, a “framework funded by the Innovative Medicines Initiative with points to consider when selecting methods for industry, regulators and regulatory bodies. health technology assessment on how to use patient preferences in decision-making regarding medical products “. The developers have submitted the framework to the EMA and EUnetHTA for review.

EUnetHTA, the European Health Technology Assessment Network and the CHMP provided parallel scientific advice earlier this year, leading to a draft opinion which expressed support for the use of studies on health preferences. patients (PPS) to inform regulatory decision-making in “certain cases”, while identifying the limitations of IMI PREFER.

“The framework, however, should not be seen as equivalent to an EMA guideline or concept paper. Regulatory experience with PPS is currently limited and therefore formal guidance from EMA on how PPS can be applied and should be carried out to successfully support marketing authorization applications is not cannot be given ”, indicates the draft opinion.

The CHMP sees potential applications of “multiple” PPS “ranging from supporting the choice of endpoints for clinical studies to generating information on tradeoffs in efficacy and safety”. As such, any PPS, regardless of membership in a framework, should be evaluated “against its goals and specific use case”. EMA encourages sponsors to seek scientific advice at the planning stage of the study if PPS is to play a significant role in their marketing authorization applications.

EMA is accepting comments until November 25.

Draft opinion, CHMP-EUnetHTA opinion

MHRA updates pharmacovigilance guidelines for post-Brexit relations with the EU

The UK Medicines and Health Products Regulatory Agency (MHRA) has updated its guidelines on pharmacovigilance procedures with new sections on how its system is affected by activities in the European Union.

The MHRA released the first draft of the guidelines late last year, shortly before the UK completed its separation from the EU. The changes made last week represent the first major update to the text and clarify the role of EU pharmacovigilance activities in the UK, now that Brexit has given the MHRA full responsibility for drug safety .

The first major change to the text concerns the detection of signals. When updating the guide, the MHRA added a request for marketing authorization holders to share with it the signal assessment reports of the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA once the recommendation is available. MHRA also added details on how to handle the new information.

“A new or modified risk which requires a modification of the terms of the marketing authorization should in principle be the subject of a request for modification of the terms of the marketing authorization, unless the holder of the marketing authorization considers that a more in-depth 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 or confirmed as new or modified risks, ”the guide says.

The MHRA has also made significant changes to a section on Periodic Safety Reports (PSURs). The new guide shows what companies should do when an EU assessment triggers changes to product information. The MHRA expects to receive a copy of the decision of the heads of the medicines agencies or the opinion of the Committee for Medicinal Products for Human Use (CHMP) as soon as possible so that it can incorporate the views of the EU in his own thinking and “avoid unnecessary divergence”.

The guide contains additional guidance on post-authorization safety studies and how the MHRA expects companies to implement the findings of EU referrals related to studies, PSURs, signal assessments and post-authorization measures.

“For UK-only MAs, you are expected to follow the EU results and make the same changes to the UK-only MA that you have made to the MA. correspondent of the EU. To do this, you will have to submit the corresponding procedure to the MHRA, ”the guide says.

The MHRA aims to contact Marketing Authorization Holders within 14 days of the publication of an EU result if its assessment leads to specific UK requirements. The deadline may be delayed if the Marketing Authorization Holder does not provide the MHRA with the data it needs to assess the situation.

MHRA Guidelines

Finland passes clinical trials legislation ahead of new EU regulations implemented

The Finnish Parliament has adopted new legislation on clinical trials to bring the law into line with new EU regulations. Most of the changes will come into force at the same time as the EU’s clinical trials regulation early next year.

Finnish politicians passed the law to allow national regulation of a range of subjects, including certain conditions for trials involving vulnerable populations, the principles of fees for sponsors and compensation paid to subjects and matters related to the supervision of clinical trials. The law also allows the Finnish Medicines Agency (Fimea) to fulfill its responsibility of preparing assessment reports.

Other aspects of the legislation propose the creation of a new National Committee for Ethics in Medical Research. The proposed committee will assess the ethics of all clinical trials in Finland and draft part of the evaluation report foreseen by the new EU regulation.

Most of the changes come into effect on January 31, the same day the EU regulation enters into force. The exceptions are the provisions relating to the processing of personal data. These provisions will take effect before the EU regulation.

Fimea review

Danish DKMA describes consultation procedure for devices containing medicinal products

The Danish Medicines Agency (DKMA) has published details of the consultation procedure for medical devices containing medicinal substances.

When evaluating these devices, notified bodies should consult the DKMA or another competent authority in the EU. Consultations are used to verify the quality, safety and usefulness of the drug substance. Notified bodies must take the results into account when making a decision on a medical device, but retain the power to choose whether or not to certify the product.

The DKMA has described the process notified bodies must follow to obtain its opinion on medicinal substances. The Danish regulator has prepared an application form and linked to the EMA guidance on the requirements of the dossier. DKMA will charge Notified Bodies 70,342 DKK ($ 11,000) per device.

DKMA Notice

MHRA shares advice on revoking converted EU licenses as part of Brexit transition process

The MHRA has shared advice on what to submit if a converted license is canceled in the UK mainland this year. The guidance applies to centrally authorized products that have been converted as part of the UK’s separation from the EU.

To facilitate the Brexit process, the MHRA automatically converted licenses and gave marketing authorization holders until the end of 2021 to file data on affected products. The updated guidelines explain that failure to provide the data on time will lead the MHRA to revoke the license. Businesses will need to reapply at normal cost and undergo a full assessment to regain market access.

If companies wish to cancel licenses, the MHRA asks them to submit information, including a cover letter and summary of product specifications. The MHRA wants the information to allow it to have a record of all licenses that have been converted to national licenses for its database.

MHRA Guidelines

© 2021 Society of Regulatory Affairs Professionals.


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