Summary of Session 3 of the TERMIS-EU Pre-Accelerator Programme 2016/2017 on the regulation on advanced therapeutic medicinal products (ATMPs).
The talks of this session were given by Dr Julian Hitchcock from Denoon Legal, and Dr Christopher Bravery from Consulting on Advanced Biologics.
The legal framework for market approval in Europe is
provided by EU directives and regulations. There are two fundamental pieces of
regulation for ATMPs:
The European Tissue and Cells Directive (EUTCD) [Directive
2004/23/EC and implementing directives] and the Advance Therapy Medicinal
Product (ATMP) Regulations (1394/2007 and 668/2009).
European Medicines Agency
and its Committee for Advanced Therapies (CAT) are the two most relevant
A product may be an ATMP scientifically, but legally it may
not be so. ATMP classification can be sought from CAT.
Market authorisation can
be sought nationally, through mutual recognition in a number of states, or
centralised in the EU through the European Medicines Agency.
For more information on the topic please read out medium.com blog post: https://medium.com/termisbpc/termis-pap-session-3-…
You can also watch the recording of the webinar through: http://termisbpc.org/pap/session-3/