EMA, The European Drug Regulatory, Publish Draft Procedural Advice on the Consultation of Notified Bodies in Accordance with Article 9 of Regulation (EC) No.1394/2007
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Advanced Therapy Medicinal Products (ATMPs) are medicinal products for human use, including gene therapy, somatic cell therapy and tissue engineered products. ATMPs may incorporate, as an integral part of the product, one or more medical devices, in which case they are referred to as “Combined ATMPs” as defined in Article 2 of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products .
ATMPs offer new treatment opportunities for diseases and injuries of the human body. The regulatory framework established by the new legislation on ATMPs is designed to ensure the free movement of these medicines within the European Union (EU), to facilitate their access to the EU market, and to foster the competitiveness of European pharmaceutical companies in the field, while guaranteeing the highest level of health protection for patients.
All ATMPs are evaluated via the centralised procedure as defined in Article 8 of Regulation (EC) No 1394/2007, thus ensuring that they benefit from a single evaluation and authorisation procedure applicable across the EU. This makes it easier for companies to market their products and for patients in the different Member States to gain access to these products.
The Committee for Advanced Therapies (CAT) prepares a draft opinion on the quality, safety and efficacy of each ATMP subject to marketing authorisation application (MAA). This opinion is then sent to the Committee for Medicinal Products for Human Use (CHMP), the committee responsible for human medicines at the European Medicines Agency (EMA). Based on the CAT opinion, the CHMP adopts a recommendation on the granting, variation, suspension or revocation of a marketing authorisation. The recommendation is then sent to the European Commission for a decision binding in all Member States. Such evaluation is done in line with the “Procedural Advice on The Evaluation of Advanced Therapy Medicinal Product in accordance with Article 8 of Regulation (EC) No 1394/2007” (EMEA/630043/2008) published in EMA website:
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/02/WC500070340.pdf
Regulation (EC) No 1394/2007 states that ATMPs may incorporate medical devices or active implantable medical devices. In order to ensure an appropriate level of quality and safety, those devices should meet the essential requirements laid down in Annex I to Directive 93/42/EEC and Directive 90/385/EEC, respectively.
As defined in Article 9(3) of Regulation (EC) No 1394/2007, where available, results of the assessment of the medical device by a notified body (NB) for medical devices shall be included in a Marketing Authorisation Application (MAA) for a combined ATMP, and in such circumstances shall be recognised by the EMA. Further consultation of a Notified Body might be found necessary in order to ask any questions relating to the results of the previous assessment of medical device (s) (MDD(s)).
If results of a NB assessment are not available at the time of the submission of the MAA, the EMA/CAT may seek an opinion on the conformity of the device part with the essential requirements of the relevant Medical Device Directives from a suitable designated NB.
It should also be noted that any interaction between the EMA/CAT and the NB(s) will be done in conjunction with the Applicant for marketing authorisation of the combined ATMP.
For More Information on ATMPs and CAT Regultions Click Here
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