Transcription of Final Concept Paper Q12: Technical and Regulatory ...
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Final Concept Paper Q12: Technical and Regulatory ...
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Secretariat, Chemin Louis-Dunant 15, Box 195, 1211 Geneva 20, Switzerland Telephone: +41 (22) 338 32 06, Telefax: +41 (22) 338 32 30 Final Concept Paper Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management dated 28 July 2014 Endorsed by the ICH Steering Committee on 9 September 2014 Type of Harmonisation Action Proposed The proposed guideline will apply to pharmaceutical products, including currently marketed chemical, biotechnological and biological products.
FINAL Q12 Concept Paper Endorsed: 9 September 2014 -3- product lifecycle management. To date, the main emphasis has been on the implementation of
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