Organisations and their Roles
The Quality by Design (QbD) approach agreed and now adopted by the EMA, FDA and the Japanese MWHL in the form of the five quality related guidelines, ICH Q8 to Q12, extends this philosophy to all parts of the product life cycle from product development, transfer through to manufacturing, manufacturing and finally product end. ICH Q8 Pharmaceutical Development describes the suggested contents of a regulatory submission based on the QbD format. ICH Q9 details a systematic approach to quality risk management, whilst ICH Q10 describes a new quality management system based on the complete product life cycle and referred to as the Pharmaceutical Quality System. ICH Q11 provides a Guideline to the “Development and Manufacture of Drug Substances”, including the type and extent of information to be submitted in regulatory dossiers, whilst Q12 provides a framework to facilitate the management of the entire “Pharmaceutical Product Lifecycle.
1. REGULATORY BODIES IN THE EUROPEAN UNION, JAPAN AND THE USA In the USA, the regulatory function is performed by the Food and Drug Administration (FDA) with technical and scientific support being provided through two centers - the Center for Drug Evaluation and Research (CDER) in respect of medicines and the Center for Devices and Radiologic Health (CDRH) in respect of medical devices e.g. inhalers. A similar function to the FDA is provided by the Ministry of Health, Welfare and Labor (MHWL) in Japan and the European Medicines Agency (EMA) , with support in the form of the Committee for Medicinal Products for Human Use (CHMP) , representing the various states making up the European Union (EU). Other prominent bodies include the Central Drugs Standard Control Organisation (CDSCO) of India, the China Food and Drug Administration (CFDA) , Health Canada and Swissmedic .
2. INTERNATIONAL REGULATION AND HARMONISATION The International Centre for Harmonisation (ICH) mentioned on Page 8 is a unique organisation consisting of representatives from the regulatory authorities in the European Union (EMA), Japan (MHLW) and the USA (FDA), and experts from the pharmaceutical industry in the three regions, in a single forum. The purpose of the ICH is to promote greater harmonisation in the ways in which the individual regulatory bodies regulate new drugs such that the medicine reaches the patient economically and with the minimum delay whilst maintaining the standards of safety, quality and efficacy necessary to safeguard public health. Current goals include finalisation of ICH Q13 (Continuous Manufacturing of Drugs) and ICH Q14 (Analytical Procedure Development.
Note : A similar organisation, the Global Harmonisation Task Force (GHTF) , exists for medical devices.
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