Tag Archives: Certification procedure

EMA Publish Guidance on Minimum Quality and Non-Clinical Data for Certification of ATMPs

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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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publish Procedural Advice on Certification of Quality and Non-Clinial Data for ATMP

EMA Publish Procedural Advice on Certification of Quality and Non-Clinial Data for ATMP

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Article 18 of Regulation (EC) No 1394/20071 provides that Small and Medium-sized Enterprises (SMEs) developing an Advanced Therapy Medicinal Product (ATMP) may submit to the European Medicines Agency (EMA) all relevant quality and, where available, non-clinical data required in accordance with modules 3 and 4 of Annex I to Directive 2001/83/EC2 (as amended) on the Community code relating to medicinal products for human use, for scientific evaluation and certification.  Provisions for the evaluation and certification of such data are laid down by the Commission in Regulation (EC) No 668/20093.
This document gives guidance and describes the procedures, timelines and practical steps to be followed by the applicants and the EMA for the submission, evaluation of a certification application and if applicable the issuing of the certificate.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”