Advanced therapeutics

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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

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Latest Life Sciences News

Life Sciences weekly highlights—3 July 2025

This week's edition of Life Sciences weekly highlights includes analysis from partners of Hogan Lovells on the key takeaways from new MDCG 2025-6 guidance on the interplay between the Medical Device Regulation/In Vitro Diagnostic Medical Device Regulation and the EU AI Act. Also included, is news that the MHRA opened applications for an expanded AI Airlock programme following last year’s pilot and published the much-anticipated guidance to support implementation of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, which come into force on 28 April 2026; the European Commission adopted new rules allowing all medical devices used by professionals to include electronic instructions for use; the DHSC announced the development of an AI system to monitor NHS patient safety in real time; and the European Notified Bodies industry group (TEAM-NB) released an updated version of its position paper on software classification under the IVDR, among other stories.

DHSC and NHS England announce new 'innovator passport' system for healthcare technology

The Department of Health and Social Care (DHSC) and NHS England have announced plans to introduce an 'innovator passport' system over the next two years. The digital system, delivered through the MedTech Compass platform, will enable healthcare technology assessed by one NHS organisation to be implemented across other NHS bodies without requiring repeated compliance assessments. The initiative forms part of the government's 10 Year Health Plan and aims to streamline technology adoption processes across the NHS. The system will operate as a centralised platform for NHS organisations to access information about assessed healthcare technologies and their supporting evidence.

MHRA opens consultation on ICH guideline for pregnant individuals in clinical trials

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on the International Council for Harmonisation (ICH) E21 guideline regarding the inclusion of pregnant and breast-feeding individuals in clinical trials. The draft guideline establishes principles for including these groups in clinical trials and drug development plans, covering scientific, regulatory and ethical considerations. The guideline aims to address the current lack of data on medicine use during pregnancy and breast-feeding by enabling appropriate inclusion in trials where medically suitable. Stakeholders can submit responses on 5 September 2025.

DHSC announces legislation for NHS single patient record system

The Department of Health and Social Care (DHSC) has announced plans for new legislation requiring healthcare providers to contribute to a single patient record system, classified as Critical National Infrastructure. The legislation will mandate all health and care providers to make patient information available in the unified system and give patients default access to their records. The system, due to launch in 2028, will be built to security standards equivalent to vital national infrastructure systems. Healthcare professionals will have secure access to patient records, with patients maintaining control over additional access permissions and receiving audit trails of record access.

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