Drug incidents such as thalidomide in the 1960s led to the revision of national drug legislation, and the strengthening of drug regulation in developed countries and some developing countries. These countries began to make stringent demands for substantial evidence of safety and efficacy. They also started to impose controls on advertising and promotion and on labelling, and required firms to adhere to good manufacturing practice (GMP). Thus in the United States, the 1962 Kefurver-Harries amendments of the Food, Drug and Cosmetic Act required firms to provide evidence of efficacy for new drugs based on adequate and controlled trials. For new drugs, results of animal tests and research protocols for human tests now had to be provided before any test on human subjects could be initiated.8
Similarly, in the United Kingdom, the Medicines Act came into force in 1971 and required the Licensing Authority to take account of the safety, efficacy and quality of medicinal products when granting licences. The Act also gave the Authority legislative power to monitor for adverse reactions, control promotion and advertising, and inspect pharmaceutical manufacturing facilities.2,9
Attempts were also made in many other countries to regulate drug production and sales by introducing new laws and regulatory mechanisms.