Advanced therapeutics

Advanced therapy medicinal products

The development of medicine, biomicrobiology and biotechnology has led to the emergence of a category of medicinal product that use gene therapy, somatic cell therapy and engineered tissues for preventing, treating or even curing human diseases. The novelty, complexity and diversity of such products has demanded new regulatory tools to allow an appropriate balancing of the risks and the benefits for the patients. EU and UK legislation regulates this category of products as ‘advanced therapy medicinal products (ATMPs)’ in order to ensure the highest level of protection of public health and to take into account their specific challenges, in particular with regard to clinical trials, manufacturing and pharmacovigilance.

There are three categories of ATMPs that are based on genes, cells (including stem cells), and tissues, respectively. ATMPs are a type of what is known as regenerative medicine (which refers to methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function and includes cell therapies, tissue engineering, gene therapy and biomedical engineering as well as more traditional treatments

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

TAKE A FREE TRIAL

Latest Life Sciences News

Council and Parliament agree crisis-related compulsory patent licensing framework

The Council and the European Parliament have reached a provisional agreement on the regulation governing compulsory licensing for crisis management purposes. The agreement, aimed at ensuring the availability of critical products within the internal market during emergencies, establishes a framework under which intellectual property rights may be exercised without the authorisation of the rights holders. The measures are designated as a last resort, with priority given to voluntary agreements between patent holders and potential users, and apply only once a crisis or emergency mode is officially activated at the EU level. Notably, the regulation excludes sectors such as gas, chips, and defence products and does not mandate the disclosure of trade secrets. The measures have been formulated in the context of addressing the fragmented national approaches previously in place, and they are designed to safeguard a high level of intellectual property protection while enhancing European crisis preparedness. The next step involves formal endorsement and adoption of the agreement by both the Council and the Parliament.

UK adopts WHO Pandemic Agreement at Geneva assembly

The Department of Health and Social Care, Foreign, Commonwealth & Development Office, UK Health Security Agency, the Rt Hon Baroness Chapman of Darlington and Ashley Dalton MP have announced that, on 20 May 2025, 124 Member States including the UK, adopted the Pandemic Agreement at the World Health Assembly in Geneva. The agreement aims to strengthen global co-operation in the prevention, detection and response to future pandemic threats, while maintaining national sovereignty. It establishes faster mechanisms for pathogen and pathogen data sharing, supporting the UK’s ability to accelerate the development of vaccines, treatments and diagnostic tools.

New Clinical Trials Regulations will bring UK closer to EU regime

Life Sciences analysis: Rory Trust, director and Fraser Campbell, trainee solicitor at Burges Salmon LLP, consider the new UK Clinical Trials Regulations which are coming into force in 2026. They also make a comparison between the UK and EU clinical trial regime, among other things.

Life Sciences weekly highlights—22 May 2025

This week's edition of Life Sciences weekly highlights includes analysis of the new UK Clinical Trials Regulation which is a major overhaul of the UK regulatory framework and news that the MHRA celebrated the steps it has taken for clinical trial reform in the UK in an International Clinical Trials Day press release and further announced the launch of a six-week consultation on the use of real-world data (RWD) for external control arms of clinical trials following its two related guidance documents on the use of RWD and real-world evidence for regulatory decisions. Also included, is news that the UK Patents Court has handed down a judgment in relation to the rare blood disease biosimilar patent dispute between Samsung Bioepis and Alexion Pharmaceuticals, the EMA updated guidance on the implementation of Policy 0070 for the publication of clinical data, the EMA also updated FAQ guidance and several documents concerning the European Shortages Monitoring Platform, the EFPIA has criticised the proposal requiring pharmaceutical companies to launch and continuously supply products in all Member States and NICE published a modular update to its health technology evaluations manual for assessing health inequalities, among other stories.