Requirements for Chemical and Pharmaceutical Data in Support of Clinical Trial Applications in the United Kingdom,Canada,the USA,the Nordic Countries,and Australia
Restricted accessResearch articleFirst published online April, 1990
Requirements for Chemical and Pharmaceutical Data in Support of Clinical Trial Applications in the United Kingdom,Canada,the USA,the Nordic Countries,and Australia
The rules governing medicinal products in the European Community — Volume II: Notice to applicants for marketing authorizations for medicinal products for human use in the Member States of the European Community (Doc. III/118/87 — EN final, January 1989); Volume III: Guidelines on the quality, safety and efficacy of medicinal products for human use (Doc. III/3305/89-EN).
2.
The DoH guidelines. In: The Guidance notes on applications for clinical trials certificates and clinical trial exemptions. Medicines Act 1968, Clinical Trial Exemption Scheme MAL 62. United Kingdom: Department of Health and Social Security; 1968.
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The Canadian guidelines. In: Chemistry and manufacturing guidelines preclinical new drug submissions. Canada: Bureau of Human Prescription Drugs, Health Protection Branch, Health and Welfare Canada; January 1984.
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Investigational New Drug Application.Code of Federal Regulation, Title 21, Part 312. Rockville, MD: Food and Drug Administration.
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Clinical trial of drugs, Nordic guidelines adopted by the Nordic Council on Medicines as a Basis for National Regulations. Guidelines Nordic Countries. Sweden: Nordic Council on Medicines.
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Guidelines for preparation and presentation of applications for investigational drugs and drug products under the clinical trials exemption scheme.CTX Guidelines Australia. Australia: Commonwealth Department of Community Services and Health, Canberra.
