38832 - Medicines and Healthcare Products Regulatory Agency (Answered)

Andrew Gwynne
To ask the Secretary of State for Health, what compliance procedures the Medicines and Healthcare Products Regulatory Agency has to ensure that its pharmacovigilance functions do not conflict with the relationships it builds with private companies when seeking business from such companies.

George Freeman

The requirements for the pharmacovigilance functions of the Medicines and Healthcare products Regulatory Agency (MHRA) are set out in European legislation through Directive 2010/84/EU and Regulation (EU) No 1235/2010 and in the Human Medicines Regulations 2012. MHRA is required to carry out independent audits of these pharmacovigilance functions and report to the European Commission every two years. This is in addition to routine reporting to the Commission on Human Medicines.

The requirements on private companies in the pharmaceutical industry that hold Marketing Authorisations for medicinal products are also set out in the same legislation and the MHRA carry out inspections to ensure these companies are compliant with the requirements. The MHRA has contact with pharmaceutical companies in its day to day business as necessary to fulfil the requirements of its pharmacovigilance functions.