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. However, each Regulatory authority will decide whether generic medicines can be included in the scope of this guideline. This guideline is intended to work with ICH Q8 to Q11 Guidelines and will provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle .
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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