Before a medicine can be sold in the UK, a number of licences are essential.
The product itself must have a licence called a 'marketing authorisation' (formerly called a ‘product licence’). In addition, the companies that are involved in all stages of the manufacture and distribution of the product need to have licences (manufacturer's and wholesale dealer's licences). New products which are still in development also need a licence before they can be tested on human subjects (clinical trial authorisations).
Applications for manufacturer's and wholesale dealer's licences require an inspection by our Medicines Inspectorate to ensure the premises and procedures are up to the necessary quality standards.
Applications for clinical trial authorisations and marketing authorisations are assessed by medical, pharmaceutical and scientific staff at the MHRA, working in multidisciplinary functional teams. Applications for marketing authorisations come mainly from the pharmaceutical industry but anyone with the necessary supporting data may apply.
The task of evaluating the beneficial effects against the possible harmful effects of any medicine is complex. Evaluation takes into account the nature of the active ingredients, the dosage form (for example, tablet or liquid), the nature of the disease or condition to be treated, the effective dose that needs to be given, the type of patient (for example, age, sex) and the duration of treatment. A high risk to benefit ratio may be acceptable in the treatment of terminally ill patients where the quality of life might be enhanced, whereas a very low risk to benefit ratio is expected in the treatment of patients with self-limiting diseases, for the purpose of prophylaxis (for example, vaccines) and for those requiring life-long treatment for their illnesses.
In arriving at a decision whether or not to grant a licence, the assessors frequently takes independent expert advice on matters relating to safety, quality and efficacy from medicines advisory bodies. These advisory bodies were appointed under Section 4 (S4) of the Medicines Act and include the Commission on Human Medicines. These bodies consist of independent experts who are appointed by Ministers. They do not include members of staff of the MHRA. Secretariat support to the advisory bodies is provided by the MHRA.