There is a rapidly expanding field of new technologies, therapies and medicines are emerging; this includes regenerative medicine, more personalised treatments, as well as the development of nanomedicines.
An Advanced therapy medicinal products (ATMPs) is a medicinal product as defined in Directive 2001/83/EC as amended (the Directive). Specifically, an ATMP is a medicinal product which is either:
a gene therapy medicinal product
a somatic cell therapy medicinal product
a tissue engineered product.
Under the ATMP Regulation, the centralised authorisation procedure will apply to ATMPs which are intended to be placed on the market in the Community.
A new committee, the committee for advanced therapies (CAT) has been established at the European Medicines Agency (EMA).
The CAT is responsible for preparing a draft opinion on the quality safety and efficacy of each ATMP for which a marketing authorisation application is submitted. The CAT’s opinion will be submitted to the EMA’s Committee for Medicinal Products for Human Use (CHMP) for final approval. In the UK, the MHRA is the supervisory authority for UK manufacturers or importers of centrally authorised ATMPs, as well as the competent authority for ATMPs.
Combination Advanced therapy medicinal products (ATMPs).A combination ATMP is defined as an ATMP that fulfils the following conditions:
it must incorporate, as an integral part of the product, one or more medical devices
its cellular tissue or tissue part must contain viable cells or tissues
its cellular or tissue part containing non-viable cells or tissues must be liable to act upon the human body with action that can be considered as primary to that of the devices referred to.
Combined ATMPs will be evaluated by the EMA. The application for a marketing authorisation for a combined ATMP which contains a medical device should include evidence that the device meets the essential requirements laid down in the medical devices legislation and where available the results of an assessment by a notified body in accordance with the medical devices legislation.