Transcription of Regulatory considerations for human medicines development ...
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Regulatory considerations for human medicines development ...
An agency of the European Union Legal basis & types of approvals Regulatory considerations for human medicines development : Legal basis for marketing authorisation applications & conditional marketing authorisations and authorisations under exceptional circumstances SME info day on 26 October 2018 Presented by Stefanie Prilla, Regulatory Affairs Office Scientific and Regulatory Management Department 1 EU Marketing Authorisations Legal basis and dossier requirements Dossier requirements Detailed pharmaceutical, non-clinical and clinical data required (CTD format). Specified in Annex I of Directive 2001/83/EC. Further clarified in scientific guidelines. Need to properly and sufficiently demonstrate quality, safety and efficacy & establish a positive B/R balance. Product development and data generation needs to be compatible with the legal basis of the application.
conditional marketing authorisations and authorisations under exceptional circumstances ... Letter of consent confirming permanent access to the data. Both medicines must have ... Comprehensive data expected to be obtained post -approval within defined timeframe. 20 MA under exceptional circumstances Criteria (at least one):
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