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Conducting clinical trials of medicines requires prior authorisation by the competent authority (Medicines and Healthcare products Regulatory Authority (MHRA)) and a positive opinion from an ethics committee.
Research Ethics Committees (REC) safeguard the rights, safety, dignity and well-being of research participants. They review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical.
In the case of clinical trials of investigational medicinal products involving children, the United Kingdom Ethics Committee Authority, in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004, requires that, where the REC does not have a member with professional expertise in paediatric care, it should “obtain advice on the clinical, ethical and psychosocial problems in the field of paediatric care which may arise in relation to that trial”.
Prior to authorisation by the MHRA, the applicant will have to show that the medicinal product has been manufactured to an acceptable quality and has been adequately tested to demonstrate how it works and what effect and benefit it is likely to have in the intended patient population. The results of tests undertaken in the laboratory, and animals as appropriate, will be provided to support the proposal that the drug can be tested in humans.
While historically medicines were often only developed for adults and not adequately researched in children, since the Paediatric Regulation (EC) No 1901/2006 on Medicinal Products came to force in 2007, it has been a regulatory requirement that paediatric research is an integral part of medicine development. Clinical trials of medicines for children conform to the same rigorous standards as that for adults and are only initiated after sufficient evidence is available to ensure the anticipated safety profile of any drug is acceptable. The MHRA endorses the aims of the Paediatric Regulation, and strongly supports activities to increase the availability of safe and effective medications for children through robust scientific and ethical studies.