Regulatory Focus™ > News Articles > 2022 > 4 > Euro Roundup: Commission seeks 5-year extension MDR/IVDR delegated acts powers

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Posted 28 April 2022 | By Nick Paul Taylor 

Euro Roundup: Commission seeks 5-year extension MDR/IVDR delegated acts powers

3058 The European Commission is seeking a five-year extension of the power to adopt delegated acts related to the new medical device and in vitro diagnostic regulations (MDR/IVDR). Officials said that an extension is needed because flexibility will be required as science advances and experience of the rules increases.
 
When the two regulations entered into force in 2017, the Commission gained the power to adopt several delegated acts. The power was scheduled to last for five years, toward the end of which the Commission needed to report to the European Parliament and the Council and check whether they oppose rolling over the power for another five years. The Commission submitted its report this week.
 
The report reveals the Commission has made little use of the power so far. Across the report, the officials make statements about the original lists of products still being up to date and having seen no technical progress that would necessitate amendments. Yet, the Commission said “the rationale for the delegations of power has not changed” and as such it wants an extension.
 
“It is important to maintain the necessary flexibility in the legal framework, to supplement or adjust it to technical and scientific developments with a view to protect health and safety of patients, users and public health in general based also on more experience gained with the application of the regulations,” the Commission wrote.
 
The Commission noted some areas where changes may be made. A revised recommendation scheduled for the first half of the year could require a change in the nanomaterial definition, and the Commission is preparing a delegated act on unique device identifiers for contact lenses.
 
Commission Report
 
EFPIA sees challenges to creation of CTR-compliant lay summaries
 
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has identified challenges to compliance with the Clinical Trials Regulation (CTR) requirement for sponsors to publish lay summaries of their study results. The pharma trade group identified “insufficient understanding of requirements among trial sponsors and trial funders” after holding a workshop to talk through the regulation.
 
European Union officials established the lay summary requirement to drive the provision of reliable and accessible information aimed at a broad audience and, in doing so, increase confidence in clinical trials. In a summary of its workshop, EFPIA said that, while the concept is simple, implementation is “far less evident.” That view is based on the “intrinsic challenges of combining readability and scientific rigor” and the “complex and potentially onerous” administrative aspects of creating and sharing the reports.
 
 
EFPIA identified a “widespread lack of awareness” and “insufficient understanding” of the requirements as core challenges. The uncertainty extends to questions about the definition of “lay summary,” with the trade group seeing “frequent confusion with the tabular summary results” that need to be submitted to the Clinical Trials Information System and other materials such as grant application summaries, protocol summaries for ethics committees and press releases.
 
As EFPIA sees it, lay summaries are covered by a four-step process—planning, development, translation and dissemination—and there are challenges at each step. The trade group estimates it takes 35 to 105 hours to write a lay summary and sees outstanding questions about the length of the documents and the extent to which they can provide interpretations of the results.
 
EFPIA is concerned that the challenges could result in inadequate compliance, which would risk harming rather than increasing trust, and “make the processes so costly and time-consuming as to imperil diligent observance of the requirement.” In response, the trade group wants to establish guidance on good lay summary practices (GLSPs).
 
The GLSP session yielded recommendations such as dedicated training and workshops but represents part of a process, rather than the end point, for EFPIA. Next, the trade group wants to refine proposals made at the event and schedule a joint workshop with stakeholders such as the European Medicines Agency and DG Santé to generate a broader consensus about lay summaries.
 
EFPIA Notice, Workshop Report
 
France’s ANSM takes legal action over compliance with clinical trial regulations
 
France’s National Agency for Medicines and Health Products Safety (ANSM) is taking legal action against hospitals in Marseille after an inspection led to allegations of noncompliance with regulations on human research.
 
ANSM began looking into l’Institut hospitalo universitaire-Méditerranée Infection de Marseille (IHU), a center headed by the controversial microbiologist Didier Raoult, and l’Assistance publique – Hôpitaux de Marseille in response to whistleblower reports. The reports triggered a November 2021 inspection that led ANSM to accuse IHU of breaching the rules on research involving humans.
 
Specifically, ANSM is concerned about the collection and use of samples and the procedures for getting informed consent. According to ANSM, there was a lack of systematic respect for ethical rules, leading it to raise concerns about the protection of participants. 
 
ANSM sees the allegations as serious enough to warrant a criminal investigation. The criminal case will advance in parallel to administrative actions to suspend some research and drive the implementation of corrective and preventative actions. ANSM is also analyzing patients treated between 2016 and 2021 because its review of the 2019 data found the frequency of serious adverse events appears to be high.
 
ANSM Notice (French)
 
MHRA seeks feedback on making overactive bladder treatment available OTC
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is gathering views on whether to make a treatment for overactive bladder available without a prescription.
 
Today, women aged 18 to 65 years with longstanding overactive bladder symptoms that are inadequately controlled by training alone need a prescription to get Aquiette. The license holder, Maxwellia, wants to convert Aquiette into a pharmacy medicine. The Commission on Human Medicines found the product meets the criteria for reclassification, leading MHRA to gather feedback on over-the-counter use.
 
MHRA is asking whether people think Aquiette should be available as a pharmacy medicine and why. The agency wants to hear from women and healthcare professionals who have experience of using Aquiette.
 
The consultation closes on 13 May.
 
MHRA Notice, Consultation Document
 
Swissmedic holds consultation to prepare for changes to multiple IT platforms
 
The Swiss Agency for Therapeutic Products (Swissmedic) is running a survey ahead of the need to renew IT platforms that are reaching the end of their life cycles.
 
Swissmedic sees the collection of views on the needs and demands of its stakeholders as essential to the planning of its IT strategy, leading it to run a survey that covers use of its eSubmissions portal. The survey asks about how often the respondent uses the portal, which modules they use and whether they access it outside their company network via a VPN.
 
Having established how people use the portal, Swissmedic asks for views on the current strengths of the system and ways in which it can be improved. Swissmedic has also asked respondents to state the extent to which they agree or disagree with statements such as the “submission of authorisation and variation applications for medicinal products is simple” and “the technical support is good.”
 
Swissmedic is accepting feedback until 6 May.
 
Swissmedic Notice
 
Other News:
 
Medicines for Europe has called for governments in central and eastern Europe to improve access to medicines by ensuring predictable market policies, avoiding “extreme price pressure” and encouraging the use of off patent medicines. Press Release

 

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