The regulation of advanced therapy medicinal products
Produced in partnership with Geneviève Michaux, Partner, King & Spalding
The regulation of advanced therapy medicinal products

The following Life Sciences guidance note Produced in partnership with Geneviève Michaux, Partner, King & Spalding provides comprehensive and up to date legal information covering:

  • The regulation of advanced therapy medicinal products
  • What is an advanced therapy medicinal product?
  • Borderline and classification issues
  • How are ATMPs regulated?
  • The ATMP Regulation
  • Other legislation relevant to ATMPS
  • Exceptions to prior marketing authorisation for ATMPs
  • Application of the ATMP rules—from collection of cells or tissues to administration of an ATMP

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see Practice Note: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

The development of medicine, biomicrobiology and biotechnology has led to the emergence of a relatively new category of medicinal products 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. European legislature 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.