Issue date: 19 March 2008
Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products (ATMPs) entered into force on 30 December 2007 and will apply from 30 December 2008.
The Regulation contains transitional provisions:
- ATMPs, other than tissue engineered products, which were legally on the Community market in accordance with national or Community legislation on 30 December 2008 will have until 30 December 2011 to comply with the Regulation.
- Tissue engineered products which were legally on the Community market in accordance with national or Community legislation on 30 December 2008 will have until 30 December 2012 to comply with the Regulation. In the interim applicants should proceed as previously by contacting the MHRA for classification of a product as a Medicinal Product (MP) or Investigational Medicinal Product (IMP). If a product containing human tissues or cells is not considered an MP or IMP by the MHRA, it will be regulated entirely by the HTA under the Human Tissue (Quality & Safety for Human Application) Regulations 2007 (the ‘Quality & Safety Regulations’) with regard to procurement, testing, processing, storage, distribution and import / export of the product. Products classified as MPs or IMPs are regulated under the Quality & Safety Regulations only as far as procurement and testing of human tissues and cells are concerned.
The MHRA, as the Competent Authority for medicinal products and medical devices, discharges the UK's national responsibilities for ATMPs (e.g. for manufacturing, distribution, clinical trials and pharmacovigilance). The HTA is the UK’s Competent Authority under the Quality & Safety Regulations and licenses the procurement, testing, processing, storage, distribution and import/export of tissues and cells for human application. Manufactured products that are classified as medicinal products by the MHRA or European Medicines Agency (EMEA) will be regulated under the Quality & Safety Regulations only for the donation, procurement and testing of tissues and cells. The subsequent stages, including manufacture, storage and distribution, will be regulated by the MHRA. Unless exempt, ATMPs will require a marketing authorisation granted by the European Commission (the ‘centralised procedure’) with the EMEA co-ordinating the application and assessment procedures, and postauthorisation supervision.
Treatments involving human tissues or cells that are not medicinal products will continue to be regulated by the HTA under the Quality & Safety Regulations for all licensable activities. This also applies to ethically (but not MHRA) approved clinical trials involving the use as grafts of human tissues and cells in patients. In cases where the regulatory status of a manufactured product derived from human tissues or cells is unclear, the MHRA should be asked to determine if the product is a medicinal product. The decision of whether a given treatment falls within the scope of the European definition of medicinal product (MP) and ATMP, as opposed to a tissue or cell graft (which would then fall under HTA remit), will eventually be determined by the EMEA working in conjunction with the MHRA (where the manufacture occurs in the UK). A Committee for Advanced Therapies (CAT) based at the EMEA will advise whether a product falls within the definition of an ATMP.