ICH Official web site : ICH The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines
ICH Official web site : ICH The ICH Harmonised Guideline was finalised under Step 4 in February 2002 This document is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the main stability Guideline
ICH Official web site : ICH It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI)
ICH Official web site : ICH The ICH Harmonised Guideline was finalised under Step 4 in November 1996 This document gives guidance on the format and content of safety updates, which need to be provided at intervals to regulatory authorities after products have been marketed
ICH Official web site : ICH In order to facilitate the implementation of the CTD General (M4) Guideline, the ICH Experts have developed a series of Q As The document which reached Step 4 of the ICH Process in June 2004, intends to clarify the key issues regarding the CTD
ICH Official web site : ICH In November 2018, the Assembly endorsed the establishment of the E14 S7B Implementation Working Group (IWG) for the development of Q As for the ICH E14 and ICH S7B Guidelines
ICH Official web site : ICH You can explore in the below table the index of all ICH Guidelines, finalised or under development, on the topics of Quality, Safety, Efficacy and Multidisciplinary
ICH HARMONISED GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3) The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities
STABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures
ICH Official web site : ICH In May 2005, an M5 consensus draft Guideline containing ICH business requirements for medicinal product identifiers, along with lists of controlled vocabularies for Routes of Administration and Units of Measurements, was published for public consultation at Step 2 of the ICH process