ATMP Regulation and Quality and Safety Regulations

From 30 December 2008, a new regulatory framework applied to Advanced Therapy Medicinal Products (ATMPs)

What are ATMPs?

ATMPs are ‘innovative, regenerative therapies which combine aspects of medicine, cell biology, science and engineering for the purpose of regenerating, repairing or replacing damaged tissues or cells’.
An ATMP is defined as either:

(a) a gene therapy ‘medicinal product’
(b) a somatic cell therapy ‘medicinal product’
(c) a tissue engineered product – a product that:

• contains or consists of cells or tissues that have either been subject to ‘substantial manipulation’ or that are not intended to be used for the same essential function(s) in the recipient as in the donor

and

• is presented as having properties for treating or preventing disease in human beings
  

What is a medicinal product?

According to the Medicines Directive a ‘medicinal product’ is any substance or combination of substances presented for treating or preventing diseases in human beings, or which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings.

The Regulation provides a framework clarifying when products containing cells or tissues will be regulated as medicinal products (and as ATMPs in particular). If a product falls within the scope of the Regulation then market authorisation is required to place the ATMP on the market. Market authorisation is granted by the European Medicines Agency (EMEA) - unless the product is exempted.

Download definitions of the terms used to define products in ATMP regulation

ATMP and the Quality and Safety regulations

The HTA and the Medicines and Healthcare products Regulatory Agency (MHRA) have prepared an ATMP Regulation and Quality and Safety Regulations joint statement.

In order to help licenced establishments that may be developing ATMPs, the HTA has also developed a series of FAQs on the ATMP Regulation.