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Unique harmonization initiative for regulators and pharmaceutical industry ; Founded in 1990 Reformed as a non profit legal entity under Swiss Law on October 23, 2015 An international nonprofit association that brings regulatory authorities and pharmaceutical industry together to HARMONIZE scientific and technical aspects of drug registration. Global platform for harmonizationICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)
A process where regulatory authorities align technical requirements for the development and marketing of pharmaceutical productsREGULATORY HARMONIZATION
REGULATORY HARMONIZATION BENEFITS AND REASONSBENEFITS - Ensuring favorable marketing conditions to support early access to medicinal products - Promoting competition and efficiency - Reducing unnecessary duplication of clinical testing REASONS - Rising costs of healthcare - Escalation of the cost of R&D - Need to meet the public expectation
Initiation of ICH1980s = European Commission, Europe Discussions between Europe, Japan, US
Initiation of ICH: PLANS FOR ACTION BEGANWHO conference of Drug Regulatory Authorities (ICDRA), Paris (1989)
Initiation of ICH: Joint regulatory-industry initiative on international harmonizationInternational Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
birth of ICH took placeApril 1990, Brussels (European Federation of Pharmaceutical Industries and Associations (EFPIA)
ICH Founding Member CountriesEurope, Japan, US
Basis for approving and authorizing new medicinal productsSAFETY, QUALITY, EFFICACY
ICH Logo explanationI, C, H = speaks for benefits of harmonisation for better global health ABSTRACT HUMAN FORM Blue Color = Health Care Purple = Complementary to Blue
ICH SloganHarmonisation for Better Health
to achieve greater harmonisation worldwide to ensure that safe, effective and high quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards.MISSION
PURPOSE OF ICH1 REDUCTION OF UNNECESSARY ANIMAL TESTING without compromising safety and effectiveness accomplished through technical guidelines implemented by the regulatory authorities 2 Prevention of unnecessary duplication of clinical trials and post-market clinical evaluations 3 Development and manufacturing of new medicines 4 Registration and supervision of new medicines 5 Post-authorisation safety reporting and pharmacovigilance Accomplished through Technical Guidelines that are implemented by the regulatory authorities
ICH MEMBERS AND OBSERVERS1 Founding / Standing Member 2 Member 3 Observer 4 Standing Observer
ICH SUCCESSES1 GCP (Good Clinical Practice) 2 CTD / eCTD (Common Technical Document) 3 MedDRA (Medical Dictionary for Regulatory Activities)
Clinical Trials conducted in one ICH region can be used in other ICH regions by setting common standards on science and ethicsGCP (Good Clinical Practice)
Brings together all Quality, Safety, and Efficacy information in a common, harmonised format, accepted by regulators in all ICH regions. It has revolutionised regulatory review processes for regulators and industryCTD / eCTD (Common Technical Document)
Highly specific, standardized medical terminology developed by ICH to facilitate sharing of regulatory information It is used for registration, documentation and safety monitoring of medical products both before and after marketing authorisationMedDRA (Medical Dictionary for Regulatory Activities)