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Drugs: Licensing

Health written question – answered on 2nd July 2012.

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Photo of Jim Cunningham Jim Cunningham Labour, Coventry South

To ask the Secretary of State for Health

(1) if he will make an assessment of whether the lessons of the thalidomide tragedy have been learned in the process of licensing new drugs;

(2) what steps he has taken to ensure that scientific reports and research published in medical journals is taken into consideration when deciding to grant licences to new drugs; and whether he is satisfied that senior officials in his Department have ownership of the process at each stage.

Photo of Simon Burns Simon Burns The Minister of State, Department of Health

The lessons learned from the thalidomide tragedy underpin the regulation of medicines used throughout the European Union.

Following the thalidomide tragedy, the United Kingdom Medicines Act received Royal Assent in 1968. This established in legislation the need for new medicines to be licensed by a competent authority before being placed onto the market in the UK. These requirements have become established in the European directives that now regulate medicines across the EU. The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK competent authority for licensing of new medicines.

The requirements for licensing of new medicines include detailed tests to be conducted in animals, including specific evaluation of embryo-fetal development, in addition to studies to evaluate the safety and efficacy of the product in human clinical trials.

The dossier supporting an application for a new drug is required to include the results of preclinical tests and clinical trials conducted by the applicant in the development of its product. This will include the full study reports and appendices in contrast to the summarised information typically included in published literature. The marketing authorisation application is required in legislation to include all information relevant to the evaluation of the medicinal product, whether favourable or unfavourable to the product and including completed trials concerning therapeutic indications that are not the subject of the application.

In the UK, the Commission on Safety of Drugs was established in 1963 in order to prevent a repeat of the thalidomide tragedy. This body has since been superseded by the Commission on Human Medicines which is independent of MHRA and has statutory responsibilities for advising Ministers on the safety of medicines.

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