PDF-INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FO

Q4B Annex 8R1 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. Our delibera tions are an important international effort to harmonise the operational policies procedures and practices of our institutions with those of partner country systems to improve the effectiveness of development assistance and thereby cont 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 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 Joint World Bank-LIS . Workshop . on database creation and survey harmonization.  . Thursday, June 6, 2013. LIS: an overview. LIS: Cross-National Data Center . • parent . organization . • located in Luxembourg. 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 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 Palvi. Shah and Becki Aquilina. 1. Overview. ONS Quality Goals and Harmonisation. The Harmonisation Vision and Strategy. Harmonisation Planning and Process. Benefits of Harmonisation. Issues and Considerations. March 2013. Claudio PARI . AGENDA. 1 . INTRODUCTION. 2 . PRINCIPLES FOR REGULATORY CONVERGENCE. 3. INTERNATIONAL STANDARD (ISO). . 4. . ICCR AND AUTHORITY/INDUSTRY GUIDELINES. Introduction. . WG NaN Activities in Harmonisation in Numbering. 5. th. WG NaN meeting. Stockholm, 21-22 November 2012. Jan Vannieuwenhuyse, Jukka Rakkolainen. NaN(2012)031rev1. See document NaN(2012)030rev1. 112. 116. Chairman of the Malta Medicines Authority. Medicines Authority. 203,Level 3,. Rue D’Argens,. Gzira,GZR 136. 8. Tel: ( 356) 2343 9000. Fax: ( 356) 2343 9161. Email: . anthony.serracino-inglott. @gov.mt.