Registration of pharmaceutical products

An official product assessment and registration system for pharmaceuticals exists in each of the 10 countries. Their functions are determined by legal provisions. Systems for registration of pharmaceutical products came into operation at quite different times in the 10 countries — as early as 1942 in Tunisia and as late as 1993 in Uganda. Some of the systems have evolved in response to dmg-related crises such as the thalidomide disaster, public pressure to expand the scope of dmg assessment and the pressure from industry and consumers to expedite the registration process. 

The professional practice of medicine and pharmacy and the public hospital system are controlled by the respective States and Territories. Other areas of healthcare, including registration of pharmaceutical products and licensing of manufacturers, are the responsibility of the Federal government. 

Qatar Ministry of Health. 7 May 1984. Requirements for Registration of Pharmaceutical Products. Drug Control Unit. Section 1. 

Directives for the Submission of Applications for the Registration of Pharmaceutical Products, subject to the Pharmacists Regulations (Medicinal... 

Table 1. Applications for registration of pharmaceutical products for humcm and veterinary use in 1993-1996.

Application for registration of pharmaceutical products for human use must contain the following documentation in duplicate, completed in Polish or English ... 

The IKS is responsible for the comprehensive assessment, eveduation cmd registration of pharmaceutical products cis well as for manufacturing controls. 

Combination products—draft advice from 1994 is valid for the first registration of pharmaceutical products containing already registered active substances and are not generics as such. Under point 6.2 of the registration guidelines. Article 6.2 concerning clinical trials, combinations products should ... 

Registration of Pharmaceutical Products Based on Medicinal Plants... 

International Conference on Harmonisation (ICH) The ICH was formed to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. The ICH is sponsored by the European Commission, the European Federation of Pharmaceutical Industry Associations, the Japanese Ministry of Health and Welfare, the Japanese Pharmaceutical Manufacturers Association, the U.S. Food and Drug Administration, and the Pharmaceutical Research and Manufacturers of America. The objective of the ICH is to harmonize the technical requirements for the registration of pharmaceutical products in the European Union, Japan, and the United States. 

National Institute of FHealth Sciences, Japan Guidance notes on registration of pharmaceutical products in Japan Web site http //www.nihs.go.jp/... 

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