NETHERLANDS – The European Parliament has voted in favor of plans to expand the European Medicines Agency’s (EMA) powers during health crises, including giving the regulator greater oversight of drug shortages.

The parliament approved the agreement, which was reached provisionally last year, with 655 votes in favor, 31 against, and eight abstentions.

The move is intended to better equip the EMA to monitor and mitigate shortages of critical medicinal products and medical devices used to address public health emergencies.

The regulator stated that all parties in the supply chain, including marketing authorization holders, wholesale distributors, and any other relevant healthcare stakeholders, will be more closely involved.

In order to facilitate data collection, the agency will also set up and manage the European Shortages Monitoring Platform.

Commenting on the news, rapporteur Nicolás González Casares said “the new regulation makes both the agency and all actors in the supply chain more transparent, involving them more in the process and fostering synergies between EU agencies.” The regulations will come into effect from March 1.

Meanwhile, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is conducting a consultation on the future of clinical trial legislation.

The MHRA is looking for feedback on a number of proposals aimed at streamlining processes and removing unnecessary burdens from clinical trial sponsors.

Because the UK left the European Union before the Clinical Trials Regulation was implemented, it is free to chart 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 giving the MHRA the authority to update the legislation, the MHRA is now seeking feedback on how to use the newly gained regulatory freedoms.

Farther afield, The European Commission is holding a public consultation on the application of the Medical Devices Regulation (MDR) to the safety of non-medical or cosmetic products.

MDR applies to products that function similarly to medical products but are used for different purposes, such as implants, dermal fillers, and body sculpting equipment used in cosmetic surgery.

The Commission has published a draft implementing regulation outlining its position on risk management, clinical safety evaluation, and other product-related requirements.

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.

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