Improving efficiency

The draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024

Life Sciences analysis: Alison Dennis, partner, and Alice Matthews, associate, at Taylor Wessing discuss the draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (the draft PMS Regulations), which were laid in Parliament on 21 October 2024.

Life Sciences weekly highlights—21 November 2024

This week's edition of Life Sciences weekly highlights includes analysis by Taylor Wessing of the new UK post-market surveillance statutory instrument to amend the Medical Devices Regulation 2002 as the first major piece of UK medical devices legislation post-Brexit and Law360 analysis of the General Court’s ruling that Boehringer Ingelheim cannot keep its three-dimensional trade mark over a lung disease inhaler because its shape is functional rather than decorative. Also included, is news that the MHRA has launched a consultation on proposed changes to the medical device regulation focusing on UKCA marking, international reliance, in vitro diagnostic devices, and assimilated EU law; news that the MHRA is consulting on ICH E6(R3) Good Clinical Practice Guideline; the MHRA is relaunching a revised Innovative Licensing and Access Pathway (ILAP) in March 2025; the EMA issued guidance for marketing authorisation holders regarding the submission of variations for 2024; NICE offered guidance to pharmaceutical companies considering the International Recognition Procedure (IRP) for UK market entry; MedTech Europe and industry bodies have called for EU regulatory oversight of Third-Party Litigation Funding; and an HMA/EMA report focuses on the use of social media data to generate real-world evidence in support of regulatory submissions, among other stories.

MHRA announces relaunch of Innovative Licensing and Access Pathway for 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a statement of policy intent regarding the relaunch of the Innovative Licensing and Access Pathway (ILAP) in March 2025. This announcement follows the success of the original ILAP, launched in 2021, which has awarded 166 Innovation Passports to date.

NICE reveals scientific advice service reduces appraisal timelines

National Institute for Health and Care Excellence (NICE) has announced that its scientific advice service can significantly reduce appraisal timelines for new technologies. A study examining guidance published between June 2020 and May 2023 found that products receiving scientific advice from NICE Advice progressed from marketing authorisation to guidance publication in a median of 312 days, compared to 400 days for those without such advice. The research, which included 230 guidance documents, reinforces the value of early engagement with NICE Advice's service in streamlining the evaluation process and potentially expediting patient access to innovative treatments.