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In 2012, at the margins of the 65th World Health Assembly conference in May the Minister of Health of Brazil proposed an agenda to create a new coalition of Heads of Agency "to address current and emerging human medicine regulatory and safety challenges globally, strategically and in an ongoing, transparent, authoritative and institutional manner."
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). [1] [2] After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada [3] and Switzerland. [1]
Medicines in India are regulated by Central Drugs Standard Control Organization (CDSCO) Under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services(India).CDSCO regulates pharmaceutical products through Drugs Controller General of India (DCGI) at chair. [citation needed] Drugs are classified under five headings.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the ...
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]