Guidance

Compliance Monitor (CM) Overview and Application Process

Updated 15 June 2022

Compliance Protocol (CP)

The remediation plan will be agreed in the form of a Compliance Protocol (CP). The CP will be approved by the MHRA, the Company, and the CM. The CP will include the agreed activities, due dates, CM resource to be applied, and frequency of periodic updates to the IAG.

Use of Compliance Monitors (CMs) to supervise implementation of Compliance Protocol (CP)

Companies that enter the pilot scheme will use consultant(s) selected from the MHRA CM register to monitor the implementation of an agreed Compliance Protocol (CP). The CM will work with the company to ensure delivery of the agreed CP and approve periodic updates confirming the implementation of the corrective actions are on-track. Additional detail will only be reported in the periodic updates by exception e.g. when delays are encountered, or significant issues are identified. The CM reserves the right not to approve the update if they do not believe that the information being presented reflects the current position. The company will be responsible for CM costs incurred during the process.

Eligibility and suitability of CMs

The ability to act as a CM will be based on the principles of eligibility and suitability.

Eligibility:

The assessment of eligibility to be named on the MHRA CM register, will be based on a combination of experience and training. To apply to be named on the MHRA register of CMs, the applicant will require:

• At least 5 years’ experience performing independent audits of GMP/GDP companies
• Provision of a suitable CV that sets out the person’s work history, any relevant qualifications, training, and clear evidence of the relevant experience
• Not having been personally the subject of MHRA regulatory action and/or significant adverse findings in the previous 3 years
• Reside in the United Kingdom

Applicants that meet the above criteria will be invited to attend MHRA training on expectations of the CM role, the use of the CP, and the requirements for periodic reporting. A fee of £300 will be charged for those undertaking the training.

Re-training will be required every 3 years, if no cases have been undertaken by the CM in that period.

Suitability

A company offered the option of using CM oversight, will be provided with the MHRA register of eligible CMs (during the pilot scheme, the register will not be publicly available). The company will review the register, discuss the case with potential CMs of their choosing, and then propose the CM they wish to use.
The MHRA will assess the suitability of the proposed CM. To be assessed as suitable, the proposed CM will require:

• Relevant and sufficient experience in the operations being carried out and the area of non-compliance identified.
• Sufficient time available to carry out the expectations of the role (the expected resource will also be identified in the CP).
• To confirm there are no conflicts of interest exist associate with their taking this role e.g. financial interest in the company.

Completion of Compliance Protocol (CP)

When the CM confirms that the CP requirements have been completed, MHRA will perform an inspection. If acceptable compliance is confirmed, closure of the referral will be recommended to the IAG. The MHRA will maintain the right to carry out inspection(s) prior to the completion of the CP if considered necessary.

Application for CM position

Please note that applications for the CM position have been suspended, as sufficient successful applications have been received for the pilot phase of the project.

Any change to this position will be communicated on this webpage.

Pilot scheme assessment

Once sufficient evidence is available from the pilot, the MHRA will assess the outcomes and determine whether it should be adopted as one of the routine IAG oversight approaches.