PPT-Importance of international harmonisation

Alexander Kühn CEPT Legal and Procedural Implementation International Specifications amp Agreements Technical Regulatory Aspects Economic and Competion Aspects Baseline for spectrum regulation Harmonisation. 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 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 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 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 ICH Bracketing and matrixinp: designs for stabil& testing of drug substances and drug prod-u& cx *$-T* Step 2 November 2000 This draft guidance, when fmlized, will represent the Food and Drug Admin RIPARTITE HE NTERVAL ROLONGATION AND ROARRHYTHMIC E14 Step 4 dated 12 May 2005 This Guideline has been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 March 2013. Claudio PARI . AGENDA. 1 . INTRODUCTION. 2 . PRINCIPLES FOR REGULATORY CONVERGENCE. 3. INTERNATIONAL STANDARD (ISO). . 4. . ICCR AND AUTHORITY/INDUSTRY GUIDELINES. Introduction. . Q_2014. Vlasta Zucha. Richard Heuberger. Directorate. . Social. . Statistics. Vienna. 3 . June . 2014. Motivations. . for. . harmonisation. Microcensus Housing Survey. , Household Budget Survey, . Standards . Workshop on ASEAN Common Food Control Requirements. 14-15 July . 2014, . Jakarta, Indonesia. 7/8/2014. 1. Standards in the SPS . Agreement. Article . 3: Harmonization. To . harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members . 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.