Euro Roundup: EMA identifies need to ‘streamline’ processes in wake of COVID-19 pandemic

A joint report into the lessons learned during the COVID-19 pandemic has identified a need for European Union regulatory agencies to “streamline and rationalize regulatory and communication processes, while maintaining ... rigorous quality standards.”

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) worked together on the report. Across the 37-page document, the agencies discuss the work the European Medicines Regulatory Network carried out during the public health emergency phase of the pandemic in an attempt to reveal ways to ensure the EU can respond rapidly to future crises and to otherwise improve its effectiveness.

One section of the report covers areas that require further improvement. In that section, EMA and HMA state that it is “imperative to have sufficient reserve resource capacity available that can be called upon in crisis situations like a pandemic.” As the agencies explain, accelerated reviews, such as those offered for COVID-19 products, can increase the workload of regulators and the Network “must ... prioritize the most promising medicines.” EMA and HMA identified streamlining and rationalization as a way to “improve efficiency.”

Another area of improvement relates to evidence generation, with the agencies identifying a “need to rapidly set up larger and more methodologically sound clinical studies to provide timely and meaningful results to inform regulatory decision making.” The need applies to both pre- and post-authorization studies.

The agencies also state that it is “crucial to improve availability of multiple sources of real-world data, such as EU healthcare data, to have more efficient tools for analysis of these data and more expertise to integrate the generated [real-world evidence] into regulatory assessments.” EMA and HMA singled out “more granular and up-to-date vaccine exposure data” as a specific requirement, noting that it is “crucial for the assessment of emerging vaccine safety signals.”

Communication with the public is another area of focus. The agencies found that “at times it was difficult for citizens to understand the rationale for different decisions by regulatory authorities and [National Immunization Technical Advisory Groups] (NITAGs) involved in vaccination policies at national level.” The rules on the use of AstraZeneca’s COVID-19 vaccine Vaxzevria, which was restricted on safety grounds in some countries, is one example of where better cooperation with NITAGs may have helped messaging.

Clear messaging is particularly important because of the “profuse amount of mis- and disinformation circulating in social media, particularly on vaccine safety.” The agencies called mis- and disinformation a “critical challenge,” adding that “efforts are needed to invest and collaborate with other public health authorities on setting up an adequate response system.”

Work is already underway to address some of the areas of improvement identified in the report. EMA has begun assessing ways to run coordinated clinical trials in public health emergencies and expects plans to create the European Health Data Space to help address some of the other issues revealed by COVID-19.

EMA Notice, Joint Report

Pharma and medtech bodies push for EHDS tweaks as Parliament adopts draft position

Pharma and medtech trade groups are keeping up the pressure on European Union officials to modify the planned European Health Data Space (EHDS) as the legislative process moves to the next step.

Last week, two committees of the European Parliament voted in favor of changes to the original plans put forward by the European Commission. The changes, which included the creation of opt-in and opt-out options, were adopted this week by Parliament. Further changes are possible if the other bodies push back on the amendments.

In the days after the committee vote, industry trade groups put out notices about their concerns. The European Federation of Pharmaceutical Industries and Associations (EFPIA) released a statement within days of the vote to warn that the opt-in and opt-out mechanism “will reduce the amount of data ultimately available within the EHDS” and “limit its ability to help advance more personalized and precise medicine.”

Days later, EFPIA, MedTech Europe and many other organizations released a joint statement calling for “legislative refinement of the EHDS.” The groups are pushing for “clear and coherent definitions,” clarification of how EHDS interacts with other legal frameworks, specifics on the scope of electronic health data categories for secondary use and steps to “avoid excessive data localization.” The joint statement only refers directly to opt-in or opt-out mechanisms once, noting how implementing those conditions will cause uncertainty if data falls into multiple categories.

The Parliament committees have identified opt-in and opt-out powers as important, in part because “consent is the legal basis for the processing of health data in some member states.”

“Processing health data for secondary use without consent of the data subject means a significant shift in data protection law as applied and would create an important precedent for further legal acts on secondary data use,” the committees wrote. “The participation of the data subjects must be ensured. Therefore, a right to a partial or entire opt-out for some or all of the purposes of secondary use should be provided.”

EFPIA Notice, Joint Statement, Draft Legislation

Commission designates five EU reference labs, advancing IVD conformity assessment strategy

The European Commission has designated five EU reference laboratories for high-risk in vitro diagnostic (IVDs) medical devices, positioning the sites to support conformity assessments starting 1 October 2024.

As part of the IVD Regulation, the EU is required to designate reference laboratories to perform certain tasks, including the verification of the performance of class D devices, assessment of compliance with common specification and batch testing. The EU put out a call for laboratories interested in performing the work last year.

Now, the EU has designated laboratories to cover four categories of class D IVDs, namely hepatitis and retroviruses, herpesviruses, bacterial agents and respiratory viruses that cause life-threatening diseases. At least two of the reference laboratories, which are from Germany, Spain and Sweden, cover each area.

There are no reference laboratories in some of the areas covered by the EU’s request for applicants. The request also covered arboviruses, haemorrhagic fever and other biosafety level 4 viruses, parasites and blood grouping.

Press Release, Implementing Regulation

EDQM publishes revised propylene glycol monograph to counter risk of contamination

The European Directorate for the Quality of Medicines and HealthCare (EDQM) has released a revised monograph on propylene glycol. Officials revised the monograph in response to the contamination of cough syrups with ethylene glycol (EG) and diethylene glycol (DEG).

Contaminated cough syrups have been linked to the deaths of children in Africa and Asia, including more than 190 fatalities in Indonesia. The European Pharmacopoeia Commission (EPC) responded by updating the monograph to add a test for EG and DEG. In response to public feedback, EPC changed the limit for EG and made other modifications to the testing process.

EPC has made the monograph available immediately on the EDQM website “given the need to act swiftly on this public health issue.” The online resource will give users advance warning of the upcoming changes and the corresponding analytical procedure. EPC will officially publish the monograph in July 2024 and bring it into force at the start of 2025.

EDQM Notice

Other News:

EMA is seeking feedback on a draft guideline about specific adverse reaction follow-up questionnaires. The guideline covers when and how to use the questionnaires as part of routine pharmacovigilance activities. Draft Guideline

Euro Roundup: EMA identifies need to ‘streamline’ processes in wake of COVID-19 pandemic

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