Today, from Revio, we would like to inform you that the European Medicines Agency has published the Revision 2 of the “Procedural advice on the provision of scientific recommendation on classification of advanced therapy medicinal products (ATMPs) in accordance with article 17 of regulation (EC) no 1394/2007”
You can look it up here.
Classification of ATMPs
Classification of ATMPs is a procedure to allow applicants to clarify, in case of doubt, whether a given product based on genes, cells or tissues meets the scientific criteria which define ATMPs. In other words, the main goal is to address, as early as possible, questions of borderline with other areas such as cosmetics or medical devices, which may arise as science develops.
Specifically, the updated document describes the procedure and gives guidance for the steps that the applicants and Agency for the ATMP classification should follow, such as:
Roles and responsibilities of parties involved
- Committee for Advanced Therapies
- EMA secretariat and coordinator
- Other Scientific Committees and Working Parties that can be consulted by the CAT in case specific scientific issues need to be addressed in order to conclude on the classification of the product. In general, the consultation takes place during the procedure and will not lead to clock stop.
Applicant must submit two documents according to the templates published on the ATMP classification webpage:
- Administrative information
- Classification request form and briefing information:
- Information on the product (active substance, finished product, mechanism of action, proposed use)
- Information on the development of the product relevant for the classification (manufacturing, quality aspects, non-clinical and clinical development)
- Applicant’s position on the classification of their product considering legal definitions in force
- Request for ATMP classification should be sent to EMA, at the latest 15 days before the start of the procedure. In relation to start dates, you can find them on ATMP classification webpage.
This EMA procedural advice on ATMP classification (revision 2) includes CAT´s overview of timelines and steps for adoption of scientific recommendation.
The Agency shall publish summaries of the recommendations delivered, after deletion of confidential information. Therefore, this public summary will have the following information:
- Product description
- Conclusion of the scientific recommendation
- Outcome of classification
This is some of the information you need to know if you are interested in the ATMPs Classification procedure by the EMA. If you want to know more, you can check out the official guideline here.
We hope you find this useful and of interest. If you would like to discuss any of these updates with the team at REVIO, please get in touch here.