The Medicines & Healthcare products Regulatory Agency (MHRA) has announced a new supervisory scheme as part of its process for monitoring Good Manufacturing Practices and Good Distribution Practices in Inspection Action Group (IAG) cases. 

When companies are referred to the IAG (typically due to critical deficiencies being identified by an inspector), this can result in frequent on-site inspections by the MHRA to assess what steps have been taken to rectify any identified concerns. The aim of the new pilot scheme is to improve efficiency in the compliance process and specifically to reduce the frequency of these on-site inspections, which the MHRA sees as a strain on its resources. This will also benefit companies by releasing resources from the disruption of coordinating MHRA supervision, allowing them to focus on the actual delivery of targets.

Beginning in April 2022, this new pilot scheme for IAG cases will see eligible consultants appointed and act as ‘Compliance Monitors’ (CM) who will be able to assist companies in meeting targets listed in their Compliance Protocol (CP) agreed with the MHRA. 

When a case is referred to the IAG the MHRA will determine whether this meets the CM process criteria. If it does, the option of CM supervision will be offered to the company and they will be able to select a CM from the MHRA register. The MHRA will ensure that the CM is appropriate for the case in question, and if confirmed the CM will be engaged by the company. The fees of the CM will be paid by the company. 

The CP will be agreed between the company, CM and the MHRA. The CM will then work with the company and regularly report to the MHRA on progress against its CP activities. It is then intended that once a company has completed its CP, the MHRA will conduct an inspection to assess whether removal from IAG is appropriate.

It must however be borne in mind that the introduction of CMs is not intended to replace the involvement of the MHRA who retain the ability to commence inspections before completion of the CP. The MHRA may also take the view that the case is not suitable for the CM process.

The MHRA has a history of taking a risk based approach to inspections, and this move is a further example of that. Should this scheme be successful, we anticipate that this will be rolled out for other areas of inspection. 

We await further details from the MHRA on how people can apply for the role of CM.