Читать книгу Clinical Pharmacology and Therapeutics - Группа авторов - Страница 116

The process of drug development, approval, manufacturing and marketing is regulated by international agreement and/or by regulatory authorities such as the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and the Japanese Pharmaceutical and Medical Devices Agency. Drug regulation in the UK and elsewhere arose following the use of thalidomide in the late 1950s and early 1960s. In 1961, it became clear that thalidomide use in early pregnancy as a treatment for morning sickness resulted in the congenital defect phocomelia, where the long bones of the foetus fail to develop properly. In the UK, this resulted in the formation of the Committee on Safety of Drugs (CSD) in 1963 and the passing of the Medicines Act in 1968, providing a system of licencing to regulate the manufacture, sale, supply and importation of medicinal products into the UK. Other European countries implemented similar systems and as early as 1965 there was a European directive to try and harmonise the processes within Europe. Currently, the EMA is responsible for the evaluation and supervision of medicines within the European Union and the UK Medicines and Healthcare products Regulatory Agency (MHRA) contributes to this work, while in the USA, the FDA fulfils a similar role to the EMA. New drugs can be reviewed and licenced across all members states simultaneously, i.e. in partnership, or the drug can get a licence from one member state first, and undergo a shortened ‘mutual recognition’ review and approval in the other member states. Developing a drug is a long and expensive process with many stages to go through before approval.