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ICH Bracketing and matrixinp designs for stabil testing of drug substances and drug produ cx T Step 2 November 2000 This draft guidance when fmlized will represent the Food and Drug Admin. O Box 195 1211 Geneva 20 Switzerland Telephone 41 22 338 32 06 Telefax 41 22 338 32 30 adminichorg httpwwwichorg Final Concept Paper Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management dated 28 July 2014 Endors Date E2F and release for public consultation. Current version E2F ICH regulatory bodies. ICH Harmonised Tripartite Guideline of the ICH Process on 16 August 2010, this guideline is recommended fo ICH HARMONISED TRIPARTITE GUIDELINE STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS E7 Current Step 4 version dated 24 June 1993 This Guideline has been developed by the ulatory parties, REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE - 1 - Final Concept P aper M7 : Assessment and C ont rol of DNA R eactive ( M utagenic) I mpurities in P harmaceuticals to Limit P ARMONISED RIPARTITE UIDELINE IMPURITIES IN NEW DRUG PRODUCTS Q3B(R2) Current Step 4 version dated 2 June 2006 This Guideline has been developed by tation by the regulatory parties, in accordance w ARMONISED RIPARTITE UIDELINE UALITY ANAGEMENT Q9 Current Step 4 version dated 9 November 2005 This Guideline has been developed by tation by the regulatory parties, in accordance with the al draft Q11 History Q11 Approval by the Steering Committee under and release for public consultation. 19 May 2011 History Q11 Approval by the Steering Committee under and recommendation for adoption to the i REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH H ARMONISED T RIPARTITE G UIDELINE P HOTOSAFETY E VALUATION OF P HARMACEUTICALS S10 Current Step 4 version dated 13 November 2 Q3C(R5) Document History First Codification History Date New Codification Parent Guideline: Impurities: Guideline for Residual Solvents Q3C Approval by the Steering Committee under and release for p Q4B Annex 8(R1) Document History Date Q4B Annex 8 Approval by the Steering Committee under and release for public consultation. 13 November 2008 Q4B Annex 8 Approval by the Steering Committee unde ICH HARMONISED TRIPARTITE GUIDELINE DOSE-RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION E4 Current Step 4 version dated 10 March 1994 This Guideline has been developed by the ulatory parties, REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH H ARMONISED T RIPARTITE G UIDELINE E VALUATION A ND R ECOMMENDATION O F P HARMACOPOEIAL T EXTS F OR U SE I N T HE ICH R E RIPARTITE HOICE OF ONTROL ROUP AND ELATED SSUES IN LINICAL RIALS E10 Step 4 dated 20 July 2000 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to RIPARTITE HE NTERVAL ROLONGATION AND ROARRHYTHMIC E14 Step 4 dated 12 May 2005 This Guideline has been developed by tation by the regulatory parties, in accordance with the al draft is recommended