14/15 December 2021
Relating to the increasing importance of advanced therapy medicinal products (ATMP) the European Commission and the EMA published a joint document in 2007 with a proposal for a community regulatory framework on ATMP. With the additional comments of DG enterprise and the industry they issued an implementation plan for the ATMP regulation (Regulation (EC) No 1394/2007) with a date for application on 30 December 2008.
In this time, the most ATMPs were in a phase of development and questions about scientific advice, registration and following marketing authorisation were more of interest than GMP issues. But with the increasing number of ATMPs and their development into phases with more GMP relevance, a more detailed guidance on Good Manufacturing Practice for Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation 1394/2007 became essential. Therefore, a first consultation on the development of such a GMP for ATMP guideline was started in July 2015.
End of 2015 the submitted comments to the "Targeted stakeholder consultation on the development of Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation 1394/2007" were summarized and published together with the responses on the European Commission's website. The majority of the 48 contributions received supported the approach in the consultation document. Important was that a significant number of responses also objected to the principle that the Guideline would not apply to the hospital exemption and/or requested clarification of the scope of the Guidelines and links with general GMP rules. It was shown that for special GMP requirements, e.g. risk based approaches or necessary cleanroom classes, additional regulatory clarification and guidance is needed.
Out of the experiences and collected comments, a Draft Guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products was developed and is now open for a stakeholder consultation until 26 September 2016. The commission published the following objective of the consultation:
"Article 5 of Regulation 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC requires the Commission to draw up guidelines on good manufacturing practice specific to advanced therapy medicinal products.
A consultation on this topic was launched in 2015. On the basis of the comments received during the consultation, as well as input from consultation with the European Medicines Agency and competent authorities in the Member States, the Commission services have developed draft Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. With this consultation, the Directorate General for Health and Food Safety wants to give an additional opportunity for concerned stakeholders to express their views on the GMP requirements that should apply to ATMPs.
The comments received will be taken into account by the European Commission to finalise the Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products."
Further details can be found at the European Commission's website on Advanced therapies - Major developments as well as the Consultation Document on Good Manufacturing Practice for Advanced Therapy Medicinal Products.