1. Medicines regulation - ensuring effective medicines with acceptable risk

Creating regulations for medicines started as a reactive process following some serious medicines-related disasters that took place during the 20^th century. In the 1930s in the USA, more than 100 children were poisoned by antibiotic syrup. The product contained the toxic substance diethylene glycol instead of sugar. In the late 1950s and early 1960s, thousands of children in Europe were born with malformations due to the use by pregnant women of a medicine containing thalidomide that was promoted for anxiety, trouble sleeping, "tension", and morning sickness. Both incidents caused massive changes in regulatory legislation.

As a result, the whole regulatory system was reshaped in the UK where a Committee on the Safety of Drugs (CSD) was started in 1963 followed by a voluntary adverse drug reaction reporting system (Yellow Card Scheme) in 1964. In the United States the Drug Amendments Act of 1962 required the FDA to approve all new drug applications (NDA) and, for the first time, demanded that a new drug should be proven to be effective and safe. In Europe the EEC Directive 65/65/EEC on the approximation of provisions laid down by law, defining regulation and administrative action relating to medicinal products was also induced by the thalidomide disaster. In subsequent years harmonisation of regulatory activities in the European Community (EC) was further developed.