Drug regulation national policy

Review of the effect of external factors on costs and returns on pharmaceutical R D, including new drug regulation, tax policy, product liability law, direct R D subsidies by the National Institutes of Health (NIH) and other government research bodies, and reimbursement policies (both private and public) for prescription drugs. 

R D is needed to bring all of these products to the market. National regulatory policies determine some of the required R D, but some R D would be undertaken even if there were no new drug regulation. 

Establishing and implementing an appropriate policy on an individual s suitability for duty, addressing adequate physical and mental fitness and aspects such as the illicit use of drugs or tobacco and alcohol abuse, in consonance with national regulations. This policy should be addressed to all employees, contractors and visitors, as applicable ... 

Two acts are pertinent to any discussion regarding the regulation of food contact materials in the US. These are the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA) and the National Environmental Policy Act (NEPA) of 1969. A brief discussion of the authority granted the Pood and Drug Administration (PDA) under each follows. 

Active promotion within a country should take place only with respect to drugs legally available in the country. Promotion should be in keeping with national health policies and in compliance with national regulations, as well as with voluntary standards where they exist. 

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