Developers of advanced therapy medicinal products (ATMPs) must be aware of the legislation governing different stages of the medicine development process, including good manufacturing practice (GMP) and good clinical practice (GCP) requirements. The European Medicines Agency (EMA) offers a range of advisory services and incentives to support the development of ATMPs.
EMA provides formal support to developers through:
- Scientific advice and protocol assistance;
- Orphan designation;
- the micro, small and medium-sized enterprise (SME) office;
- Classification of advanced therapy medicinal products (ATMPs);
- Certification of quality and non-clinical data for SMEs.
The legislation provides for scientific and financial incentives to encourage research and development in the area of advanced therapies. Developers of ATMPs can obtain reductions in the fees payable to EMA of:
- 65% fee reduction for a request for scientific advice for ATMPs (90% for SMEs);
- 90% fee reduction for the certification procedure.
The Innovation Task Force provides a forum for informal dialogue between EMA and developers of ATMPs in the early stages of the medicine development process. Registered SMEs may approach the SME office to request a briefing meeting to discuss their planned regulatory strategy.
Information on how to apply for SME incentives are detailed under SME office.
GMP and GCP requirements
- GMP requirements
Developers of ATMPs need to be aware of the legislation that is applicable to different stages of the process. Utilisation of substances of human origin such as blood, tissues and cells in the manufacture of an ATMP requires compliance with relevant legislation (Directive 2002/98/EC and associated implementing directives and Directive 2004/23/EC and associated implementing directives) in relation to procurement, donation and testing.
Subsequent manufacture of ATMPs must be performed in compliance with Directive 2001/83/EC and in line with the GMP guidelines.
These guidelines are divided into three parts with an additional 22 annexes that give specific guidance on manufacture of certain products and utilisation of certain technologies. While all three parts of the guidelines are applicable to ATMPs, one annex specifically deals with ATMP manufacturing: Annex 2 - Manufacture of biological active substances and medicinal products for human use.
Specific attention should also be given to Annex 13 - Manufacture of investigational medicinal products and Annex 16 - Certification by a qualified person and batch release.
- GCP requirements
Detailed guidance on specific GCP requirements for ATMPs is available from the European Commission:
These draft guidelines supplement Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for GCP as regards investigational medicinal products for human use.
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