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Regulatory Focus™ > News Articles > 2022 > 1 > Euro Roundup: MHRA seeks feedback on proposals for the future of UK clinical trial legislation

Euro Roundup: MHRA seeks feedback on proposals for the future of UK clinical trial legislation

Posted 20 January 2022 | By Nick Paul Taylor 

Euro Roundup: MHRA seeks feedback on proposals for the future of UK clinical trial legislation

The Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation into the future of clinical trial legislation in the UK. MHRA is seeking feedback on tens of proposals intended to streamline processes and remove unnecessary burdens to clinical trial sponsors.
 
Having left the European Union before the implementation of the Clinical Trials Regulation, the UK is free to plot its own course as it seeks to establish itself as the best place to research and develop safe and innovative medicines. With the Medicines and Medical Devices Act 2021 providing powers to update the legislation, MHRA is now seeking feedback on how to use the recently gained regulatory freedoms.
 
MHRA has grouped its proposals into 10 categories, such as patient and public involvement, clinical trial approval processes and safety reporting. The sections feature multiple proposals and questions to gauge the industry response to them.
 
One MHRA idea is to require the involvement of “people with relevant lived experience in the design, management, conduct and dissemination” of clinical trials. Currently, Research Ethics Committees expect researchers to involve patients and the public in those processes, but there is no legislative mandate. As part of a wider effort to embed patient engagement in drug development, MHRA wants the legislation to require the involvement of people with relevant lived experience.
 
Elsewhere, MHRA is seeking feedback on changes to the clinical trial approval process, including a move to a combined regulatory and ethics review and “a sponsor-driven timeline to respond to any requests for further information.” MHRA sees the combined review as a way to give sponsors “a single UK ’front door’” and plans to enable a single process for appeals. The agency also shared its thinking on the switch to a sponsor-driven timeline.
 
“We would aim to minimize, and ideally avoid, UK-specific changes in how a trial is conducted caused by non-concurrent assessment procedures from multiple regulators in different countries. To support this, we propose to provide for a generous time period (nominally 60 days but with flexible extension) for a sponsor to respond to any requests for information raised which would facilitate the harmonization of international protocols and better align requests for changes from multiple regulators,” MHRA wrote.
 
Other proposals are intended to reduce the regulatory burden on lower-risk clinical trials. MHRA plans to create a notification system for low-intervention trials that pose similar risks to standard medical care, thereby freeing them from the need for regulatory review. Similarly, MHRA is considering changing the informed consent requirements for cluster trials that randomize patients to receive approved medicines. MHRA is questioning whether people should need to provide “written consent after being given detailed information about the trial in an interview with one of the investigators” to participate in such studies.
 
The full set of proposals and questions about them runs to almost 10,000 words. MHRA is accepting feedback on the proposals until 14 March. After the eight-week consultation, MHRA will review the responses and use them to inform decisions to finalize the drafting of the secondary legislation.
 
Press Release, MHRA Consultation
 
European Commission starts consultation on MDR and aesthetic medical devices
 
The European Commission is holding a public consultation about the application of the Medical Devices Regulation (MDR) to the safety of products with an aesthetic or non-medical purpose.
 
MDR applies to products that have a similar function to medical products but are used for different aims, such as implants, dermal fillers and body sculpting equipment used in cosmetic surgery. The Commission has published the draft implementing regulation to set out its stance on risk management, clinical safety evaluation and other requirements related to the products.
 
One part of the proposal sets out requirements that apply to all products. The Commission is proposing to give manufacturers of products already on the market three years from the date of application of the regulation to confirm their conformity with those general safety and performance requirements. Specific requirements for different types of devices are set out in a series of annexes.
 
The Commission is accepting feedback until 11 February.
 
Commission Notice
 
EU Parliament body warns expansion of EMA role will create ‘significant pressure’
 
The public health committee of the European Parliament has warned the expansion of the European Medicines Agency’s (EMA) role “puts the continuity of its operations under significant pressure at an already critical time.”
 
Members of the Committee on the Environment, Public Health and Food Safety (ENVI) are concerned that authorities are imposing “significant new tasks” on EMA, after several years in which its workload has grown, without corresponding increases in its staff and resources. ENVI fears the situation will leave EMA short-staffed.
 
To improve the situation, ENVI wants the Commission to “evaluate in detail the feasibility of granting EMA additional capacity to manage shortages.” Some of the shortage powers now being granted to EMA were not in the original proposal for its expansion, which suggested giving the agency an additional 40 staff and €100 million ($114 million) over a seven-year period.
 
ENVI’s intervention comes weeks after EMA executive director Emer Cooke told Parliament: “We need help. I think we definitely need help. We do need additional human resources.”
 
ENVI Opinion
 
MDCG calls for manufacturers of COVID-19 tests to make IVDR filings soon
 
The EU Medical Device Coordination Group (MDCG) has called for manufacturers of COVID-19 tests to contact a notified body designated under the In Vitro Diagnostic Regulation (IVDR) as soon as possible.
 
Under IVDR, all SARS-CoV-2 in vitro diagnostics are subject to conformity assessment involving a notified body. The staggered rollout of IVDR has eased the pressure on the IVD industry as a whole to get its existing products certified but MDCG, which advises the Commission on medical device and IVD matters, wants manufacturers of COVID-19 tests to act soon.
 
“Manufacturers that wish to place devices on the market in accordance with [IVDR] ... are strongly encouraged to liaise with designated notified bodies as soon as possible. A good quality of the documentation prepared by the manufacturer will facilitate the assessment by the notified body,” MDCG wrote.
 
There are currently six IVDR notified bodies clustered in three countries in the EU, compared to almost 20 that are designated to certify diagnostics under the outgoing directive.
 
MDCG Notice
 
EMA highlights positive safety data on mRNA COVID-19 vaccines during pregnancy
 
EMA’s COVID-19 task force (ETF) has highlighted growing evidence that mRNA COVID-19 vaccines do not cause pregnancy complications for expectant mothers and their babies.
 
ETF reviewed several studies that enrolled around 65,000 pregnancies at different stages and found no sign of increased risk of pregnancy complications, miscarriages, preterm births or adverse effects in the unborn babies following mRNA COVID-19 vaccination. While noting some limitations in the data, ETF said the results appear consistent across the different studies.
 
The side effects in pregnant women were in line with those seen in the broader population, with injection site pain, tiredness and headache among the most common reports. The studies also found the vaccines reduce the risk of hospitalization and death, an important finding given evidence of the higher risk of severe COVID-19 in women in the second and third trimesters.
 
EMA Notice

 

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