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Christopher Konovalov
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International Conference on Harmonisation: The History, Structure, Function and Benefits of a Unique Harmonisation Project



International Conference on Harmonisation: What Is It and Why Is It Important?




If you are involved in any aspect of pharmaceutical development or regulation, you have probably heard of or used the International Conference on Harmonisation (ICH) guidelines. But what exactly is ICH and why is it important? In this article, we will explain what ICH is, how it works, what it does, and how you can access its guidelines for free.




International Conference On Harmonisation Pdf Free



The History of ICH




The Need to Harmonise




The idea of harmonising regulatory requirements for pharmaceutical products was driven by several factors in the late 20th century. First, there were several tragedies that exposed the need for an independent evaluation of medicinal products before they are allowed on the market. One such tragedy was thalidomide, a drug that caused severe birth defects in thousands of babies in Europe in the 1960s. Second, there were challenges posed by rising costs of health care, escalating costs of research and development (R&D), and increasing globalisation of the pharmaceutical industry. These challenges made it difficult for industry to duplicate many time-consuming and expensive tests in order to market new products in different regions. Third, there was a public expectation that safe and effective new treatments should be made available to patients in need as soon as possible.


The Initiation of ICH




Harmonisation of regulatory requirements was pioneered by the European Commission (EC) in the 1980s, as it moved towards the development of a single market for pharmaceuticals. The success achieved in Europe demonstrated that harmonisation was feasible. At the same time, there were discussions between Europe, Japan and the US on possibilities for harmonisation. It was at the World Health Organization (WHO) Conference of Drug Regulatory Authorities (ICDRA) in Paris in 1989 that specific plans for action began to materialise. Soon afterwards, the regulatory authorities approached the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) to discuss a joint regulatory-industry initiative on international harmonisation, and ICH was conceived. The birth of ICH took place at a meeting in April 1990, hosted by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in Brussels. Representatives of the regulatory agencies and industry associations of Europe, Japan and the US met to plan an International Conference but also discussed the wider implications and terms of reference of ICH.


The Structure and Function of ICH




The ICH Assembly




The ICH Assembly is the governing body of ICH, which was established as an international association under Swiss law in 2015. The ICH Assembly consists of representatives from the six ICH regions (Europe, Japan, US, Canada, Switzerland and South Korea) and 16 ICH observers (including WHO, China, Brazil, India, etc.). The ICH Assembly meets twice a year to oversee the strategic direction, policies and procedures of ICH.


The ICH MedDRA Management Board




The ICH MedDRA Management Board is the custodian of the Medical Dictionary for Regulatory Activities (MedDRA), which is a standardised terminology for reporting adverse events and other medical information related to medicinal products. The ICH MedDRA Management Board consists of representatives from the six ICH regions and four non-ICH regions (Australia, China, Russia and Taiwan). The ICH MedDRA Management Board meets twice a year to oversee the development, maintenance and promotion of MedDRA.


The ICH Management Committee




The ICH Management Committee is the executive body of ICH, which is responsible for managing the day-to-day operations of ICH. The ICH Management Committee consists of representatives from the six ICH regions and four standing working groups (Quality, Safety, Efficacy and Multidisciplinary). The ICH Management Committee meets four times a year to coordinate the work of the working groups, monitor the progress of guideline development and implementation, and address any issues arising from the operation of ICH.


The ICH Secretariat




The ICH Secretariat is the administrative arm of ICH, which provides support to all other bodies and activities of ICH. The ICH Secretariat consists of a small team of staff based in Geneva, Switzerland. The ICH Secretariat organises the meetings of the Assembly, the Management Committee and the working groups, maintains the official website and documents of ICH, facilitates communication among stakeholders, and manages the finances and legal affairs of ICH.


The ICH Working Groups




The ICH Working Groups are the technical experts who develop and maintain the ICH guidelines. The ICH Working Groups consist of representatives from regulators and industry associations from the six ICH regions and observers from non-ICH regions. The ICH Working Groups are divided into four categories: Quality, Safety, Efficacy and Multidisciplinary. Each category has several topics that cover different aspects of pharmaceutical development and regulation. The ICH Working Groups meet regularly to draft, revise and update the guidelines according to the needs and feedback from stakeholders.


The ICH Guidelines




The Categories of ICH Guidelines




The ICH guidelines are divided into four categories: Quality, Safety, Efficacy and Multidisciplinary. The Quality guidelines cover the chemical and pharmaceutical quality assurance aspects of medicinal products, such as stability testing, impurities control, analytical validation, etc. The Safety guidelines cover the non-clinical safety evaluation aspects of medicinal products, such as toxicology testing, carcinogenicity assessment, pharmacokinetics, etc. The Efficacy guidelines cover the clinical efficacy and safety aspects of medicinal products, such as clinical trial design, statistical analysis, dose-response studies, etc. The Multidisciplinary guidelines cover topics that cross-cut several categories, such as pharmacovigilance, electronic data exchange, genomic biomarkers, etc.


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