Advanced therapy medicinal products: regulation and licensing in UK

How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.

An advanced therapy medicinal product (ATMP) is a medicinal product which is either:

The definition of ATMP is in the Human Medicines Regulations 2012 and includes combination ATMPs.

In the UK, the MHRA is the competent authority:

2. Getting a classification opinion or advice about ATMPs

If you are not sure if your product is an ATMP or which type of ATMP it is, refer to this flowchart (PDF, 32.1KB, 5 pages). If you are still uncertain, contact the MHRA Innovation Office by either:

The MHRA will classify your product as an ATMP where appropriate.

3. Regulatory queries on regenerative medicines (one-stop shop)

All regulatory enquiries about regenerative medicines should be made through the MHRA Innovation Office.

The Innovation Office is the single point of contact for all the regulators involved in regenerative medicines:

To contact the innovation office, either:

You can get scientific advice from MHRA at any stage of ATMP development. There is usually a fee for this service. See Current MHRA fees.

British Pharmacopoeia support for ATMP developers

The British Pharmacopoeia (BP) supports innovation in advanced therapies through the provision of public quality standards and non-mandatory guidance to support the development, manufacture and control of advanced therapy medicinal products (ATMPs). Further information, including free to download ATMP-related guidance, can be found on the British Pharmacopoeia website.