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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.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; ... Pharmaceutical legislation: medicinal ...
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."
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.
The International Conference on Harmonisation sets out guidelines for registration of pharmaceuticals in multiple countries. It defines Good Clinical Practice (GCP), which is an agreed quality standard that governments can transpose into regulations for clinical trials involving human subjects.
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 ...