EMA Publish Guidance on Minimum Quality and Non-Clinical Data for Certification of ATMPs
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This guideline describes the minimum quality and non-clinical set of data that Small and Medium-sized Enterprises (SMEs)1 developing Advanced Therapy Medicinal Products (ATMPs) should submit for scientific evaluation when seeking EMA certification of quality, or quality and non-clinical data under Article 18 of Regulation (EC) No 1394/2007.
The certification procedure, as described in Regulation (EC) No 1394/2007 and in the implementing Regulation (EC) No 668/20093, is an incentive for SMEs to develop ATMPs. It provides for a scientific evaluation and subsequent certification of quality and, where available, non-clinical data submitted within the scope of the procedure.
From a legal perspective, SME applicants can submit applications for certification of ATMPs at any stage of development. To allow for a meaningful certification, a minimum level of product development will be required prior to the submission of an application. It is not possible to certify a product at a conceptual stage (e.g. certification of platform technologies, novel assays, intermediates such as cell banks only (as defined in ICH 5D4)) without knowing the intended clinical use of the ATMP and initial manufacturing and testing data. Therefore, the dossier should include a clear description of the active substance II/ finished medicinal productIII that is being developed, as well as description of the
intended clinical use / indication and the proposed route of administration.
In the course of the ATMP development the applicant will complete progressively the entire set of quality (Module 3) and the non-clinical (Module 4) data. This data should be available by the time of the submission of the Marketing Authorisation Application (MAA). The data submitted for the certification will be a subset of Module 3 and/or 4 and should be presented in line with Annex I to Directive 2001/83/EC5, i.e. in the format of the Common Technical Document (EU-CTD)6. In this regard a risk analysis and eventual clinical experience, although not part of the certification procedure, should be provided in as in module 2 to be supportive and valuable to define the stage of product development and the intended use of the product.
The certification system aims at giving SMEs an incentive to develop ATMPs and, although it is independent from any application from marketing authorisation, it could facilitate the evaluation of any future application for clinical trial and marketing authorisation based on the same data.
In the foreseeable future, it is expected that with growing experience of the Committee on Advanced Therapies (CAT), there may be a need to update this procedural guidance.
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