Transcription of Q12 - ICH
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Q12 - ICH
INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE TECHNICAL AND regulatory CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT Q12 Draft version Endorsed on 16 November 2017 Currently under public consultation At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures. Q12 Document History Code History Date Q12 Endorsement by the Members of the ICH Assembly under Step 2 and release for public consultation (document dated 31 October 2017). 16 November 2017 Legal notice: This document is protected by copyright and may, with the exception of the ICH logo, be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the document is acknowledged at all times.
Regulatory authorities are encouraged to utilise a system that incorporates risk-based regulatory processefor (a) requesting approval from the regulatory authority, (b) s notifying the regulatory authority, or (c) simply recording CMC changes, with associated information requirements and, where applicable, timeframes for decision.
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