Euro Roundup: Commission calls for input on reducing postmarket variations burden

The European Commission is seeking feedback on how to improve the postmarket variation framework. Officials are looking for a short-term solution that accelerates the authorization of variations to bridge the gap to the implementation of changes through the revision of general pharmaceutical legislation.

In 2020, the European Union named the revision of the variation framework for medicines as one of its initiatives on regulatory efficiency for the coming years, underpinned by the recognition that the variation process needed to be simplified to make the lifecycle management of medicines more efficient and adapted to digitalization.

“It should enable efficiency gains to be made under the current legal framework of post-authorization changes to a marketing authorization for medicines for human use. The initiative aims to achieve this by reducing the administrative burden for marketing authorization holders and authorities and freeing up resources currently taken up by the large number of variations,” the Commission wrote in a call for evidence from stakeholders affected by the variation process.

Officials identified a need for change after receiving “several indications from industry and the regulatory authorities that there is room for improvement in the current variation framework, in terms of efficiency, flexibility and keeping pace with scientific and technological progress.” The growth in the number of centralized marketing authorizations, from 5,385 in 2012 to 8,359 in 2022, is another factor because it means “a disproportionate amount of resources are required to handle and maintain” approvals.

The draft pharmaceutical legislation includes additional tools to facilitate post-authorization changes that are intended to address the problems, but the Commission said “it is likely to be some years before these take effect.” In the interim, officials are looking for ways to “make the postmarketing lifecycle management of medicines more efficient, by reducing the administrative burden for the pharmaceutical industry and making better use of regulatory authorities’ resources.”

“This may include a re-classification of some variations into lower categories and/or the introduction of additional flexibility, especially with regard to the level of technical information that must be provided. The initiative will clarify the changes and data to be communicated to the authorities. It also proposes to simplify the single submission or notification of variations (grouping) and work-sharing procedures,” the Commission wrote. The administration of some processes has become “increasingly complex.”

Through the changes, the Commission hopes to “enable marketing authorization holders to introduce timely manufacturing or quality improvements embracing new technologies and digitalization approaches” and ultimately “give patients timely access to high-quality, effective and safe medicines and enhance the attractiveness of the EU regulatory system for medicinal products.”

The Commission is accepting submissions until 26 September.

Communication

Commission seeks feedback on effectiveness of communications about MDR, IVDR

The European Commission is holding a consultation to understand the information needs of companies directly affected by the Medical Device Regulation and the In Vitro Diagnostic Regulation (MDR/IVDR).

To uncover communication challenges and smooth the regulatory transition, the Commission is asking affected stakeholders how they receive information about MDR and IVDR and whether the available materials meet their needs. One question asks: “Do you think the updates available in the newsletter or DG SANTE website include adequate details to help you take the appropriate measures to avoid market disruptions in the supply of medical devices?”

The commission also wants to know if the documents are “engaging/informative enough” to relay to other stakeholders via social media and websites. Additional questions cover whether the language used in communications is clear enough, and if not what the specific problem is, and to what extent the materials meet the needs of stakeholders affected by the regulations. A final set of questions request details of the respondent and the organization they work at.

The survey could provide the Commission with insights that improve communication and reduce the risk that information-sharing shortcomings will lead to problems with the ongoing switch to MDR and IVDR.

Commission Survey

MHRA outlines impact of revised pharmacovigilance compliance model on inspection findings

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has discussed how changes to its good pharmacovigilance practice (GPvP) model has affected the findings of its inspections.

MHRA introduced a revised GPvP inspection model in its 2020 to 2021 financial year. The model aimed to facilitate the selection of appropriate pharmacovigilance systems, products and non-interventional studies to inspect. MHRA discussed the impact of the new model on its inspection findings in a report on the outcomes of the assessments it performed in its 2021 to 2022 financial year.

“It is clear that risk management was an area of significance when reviewing the metrics. Three of the four inspection arms have a primary focus in the risk management area. Accordingly, a large number of findings have been reported under this topic. Findings of all gradings were spread across each of the subtopics in risk management, highlighting the importance of managing risk to patients at all points of the product lifecycle and across critical pharmacovigilance processes,” MHRA wrote in its report.

MHRA plans to continue to apply a risk-based approach to inspection scheduling under each of the four inspection arms, prioritizing visits based on the product risk profile, the complexity of pharmacovigilance systems and intelligence received from external and internal sources. The team will use a hybrid model and decide whether to perform inspections on site or remotely based on a range of factors.

MHRA Report

EU safety committee recommends tightening restrictions on topiramate exposure in pregnancy

The European Medicines Agency’s (EMA) safety committee has recommended further restricting the use of the epilepsy drug topiramate during pregnancy to reduce the risk of neurodevelopmental problems.

The Pharmacovigilance Risk Assessment Committee (PRAC) is recommending that topiramate be used in pregnancy if no other suitable treatment is available. The committee is also calling for a pregnancy prevention program that ensures patients are informed of the risks of taking topiramate during pregnancy and the need to avoid becoming pregnant while taking the medicine. PRAC’s position is informed by three recent observational studies.

EMA Notice, More

Other news:

EMA has started consultation into the use of a surrogate endpoint in chronic kidney disease (CKD) trials. The draft qualification opinion covers the use of GFR slope as a surrogate endpoint in randomized CKD studies. EMA provisionally concluded that GFR slope can serve as a surrogate endpoint for marketing authorization and label extensions in some settings, if properly specified and assessed. Draft Opinion, More

Euro Roundup: Commission calls for input on reducing postmarket variations burden

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