Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the adequacy of the criteria used by the Medicines and Healthcare products Regulatory Agency in granting licences for medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) together with the Commission on Human Medicines (CHM) and its expert advisory groups (EAGs) operates procedures to support the development, evaluation and granting of licences of medicinal products. In the United Kingdom, all medicinal products for human use are subject to a system of licensing laid down by the UK Human Medicines Regulations (HMRs). Medicines licensing procedures protect public health by ensuring that harmful products do not get licensed and that products are licensed with appropriate indications, dosage, precautions and warnings. For a marketing authorisation to be granted, medicinal products have to meet pre-defined and stringent criteria on efficacy, safety and quality. A marketing authorisation can only be granted when the benefit-risk in relation to quality, safety and efficacy is found to be positive.

The MHRA has a number of licensing pathways available, with the aim of ensuring the products can be made available for patients in the UK in the shortest time possible and to support and protect public health. Common for all these procedures, is the focus on the quality, safety and efficacy of the product. The review is conducted by a multidisciplinary team of assessors, to ensure a thorough and broad assessment of the product. Independent advice from the CHM and its EAGs is sought for any complex issues or those that may pose a risk to patients or public health by the identification of Major Objections. Pharmaceutical companies are required to provide a risk management plan outlining known safety concerns, pharmacovigilance activities and risk minimisation measures. In addition, for novel products, additional safety monitoring is put in place for the early stages of the lifecycle.