While the MHRA has been incorporating elements of risk management into its inspection programme for a considerable time, the Agency’s commitment to the Hampton principles and the Government agenda for Better Regulation (external link) has focused efforts in this area.
The work of the MHRA’s Good Practice Inspectorates covers all aspects of good practices associated with the inspection of clinical, pre-clinical and quality control laboratories, clinical trials, manufacturers, wholesalers and pharmacovigilance systems.
As part of the Government’s Better Regulation initiative, the Department of Health (DH) can deliver its primary goal, to improve the health and well-being of people across England by developing effective, proportionate and efficient regulation. To help achieve this the DH has developed a simplification plan, which sets out how it proposes to deliver its key priorities through better regulation and is a living document which will be regularly updated with changes. More information on the Department of Health’s simplification plan can be found on the Department of Health website (external link).
On 1 April 2009, the MHRA introduced a formal risk-based inspection programme following public consultation MLX 345 and a pilot study involving industry in the last quarter of 2008. The ongoing development of this formal Risk-Based Inspection Programme will enable inspectorate resources to be concentrated in those areas that maximise protection of public health while reducing the overall administrative and economic burden to stakeholders.
The Agency welcomes feedback on the implementation and development of the Risk-Based Inspection Programme from interested parties.
For specific information on the Risk-Based Inspection Programme for a particular good practice please select from the links below:
Good Pharmacovigilance Practice
