Advanced Therapy Medicinal Products (ATMPs) are medicines based on genes, tissues or cells for human use. ATMPs offer an innovative perspective for the treatment of disease and injury.
These medicinal products may fall under one of the three following types:
- Gene Therapy medicinal products – Contain genes which result in a therapeutic, prophylactic or diagnostic effect by inserting ‘recombinant’ genes into the body, usually for the treatment of various diseases.
- Somatic-cell Therapy medicinal products – Contain cells/ tissues which have been engineered to alter their biological characteristics/ cells/ tissues in order to be used for a different functions in the body and may be used to cure, diagnose or prevent disease.
- Tissue-engineered products- Contain modified cells/ tissues in order to be used to repair, regenerate or replace human tissue.
Additionally, some ATMPs may be referred to as combined ATMPs, these contain one or more medical devices as an integral part of the medicine, for example, cells embedded in a biodegradable matrix/ scaffold.
Additionally, Stem Cells are categorised as ATMPs following substantial manipulation or use for a different essential function, these may be classified under somatic-cell therapy products or tissue-engineered products, depending on how the medicines react to the body.
Healthcare providers should explain the benefits and risks of any cell-based therapies recommended to patients, as well as ensuring confirmation from the relevant regulatory authorities that their use has been approved.
Following Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA), Regulator for Great Britain, advised that Marketing Authorisation Applications for Advanced Therapy Medicinal Products (ATMPs) will be regulated nationally according to the same principles that were previously applied. Marketing authorisation applications for ATMPs will thus be assessed in accordance with the general provisions in place for the licensing of medicines, taking into account the specific requirements for this group of medicines. Data, traceability, exemptions from licensing, packaging and post-authorisation requirements will remain unchanged from the current EU requirements and will be transposed into UK law. If uncertain about your product’s classification fill out the ATMP advice form, or refer to the Reflection Paper on the classification of advanced therapy medicinal products (EMA/CAT/600280/2010 rev.1), using the links below.
In Northern Ireland, ATMPs will continue to be regulated according to the EMA’s Centrally Authorised Procedure.
ATMP advice form:
https://info.mhra.gov.uk/forms/atmp_form.aspx
Reflection paper on classification of advanced therapy medicinal products (EMA/CAT/600280/2010 rev.1):
For detailed definitions of the different groups of advanced therapy medicinal products, refer to
https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32007R1394
http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1410944582971&uri=CELEX:02001L0083-20121116