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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.
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 ...
ICH E6 includes details of only a minimum list of contents and no other regulation or guideline provides a comprehensive list of TMF content. As a result of the inconsistencies that were developing across the sector, an industry group comprising 7 members from the GCP-RMA (Good Clinical Practice Records Managers Association) decided to develop ...
If inventor granted patent of introduction, the invention will be valid for a period of 15 years. Further five years patent may be valid if invention is properly worked in Ethiopia. [8] Ethiopia's first intellectual property law was enacted in 2006, which included provisions for patents, trademarks, copyrights, and industrial designs.
Section 5: Other Test Guidelines; Guidelines are numbered with three digit numbers, the section number being the first number. Sometimes guidelines are suffixed with a letter. Guidelines are under constant review, with guidelines being periodically updated, new guidelines being adopted, and guidelines being withdrawn.
The Ministry of Health (MoH) (Amharic: ጤና ሚኒስቴር) is the Ethiopian government department responsible for public health concerns. Its head office is on Sudan Street in Addis Ababa. [2] Mekdes Daba has been the head of the ministry since February 2024. The organization is a cabinet level organization which has authority over the ...
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