Authorities test Hybrid Inspections

Recommendation

7/8 May 2024

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The ICMRA (International Coalition of Medicines Regulatory Authorities) is a voluntary association of medicines regulatory authorities around the world for overarching strategic coordination and advocacy, particularly in regulatory matters. The EMA is also a member.

One objective is to improve coordination between regulatory authorities in the review of CMC submissions, e.g. through submissions of information in the same format (e.g. according to the harmonised standards of ICH M4Q, M8, etc.) and the same standards for sponsor submissions. Now there are two pilot projects in this regard; one on a possible cooperative assessment in the CMC area and one on the implementation of hybrid inspections*.

The two pilots are being conducted under the auspices of ICMRA to assess the feasibility and potential for further collaboration and convergence between regulators on specific data expectations and assessment approaches in the evaluation of production facilities for Pre-Approval and Pre-License Applications (PAI and PLI, respectively) and Post-Approval Change Application (PAC) reviews.

What are the hybrid inspections about?

These are primarily intended to serve as a basis for the assessment of drug applicants in the context of the CMC assessment of pre-market or PAC.

This proposed pilot programme uses a combination of an on-site inspection and a remote inspection (via a virtual platform). This involves several interested regulatory authorities. The inclusion of an installation in the pilot programme is based on the mutual interest of the supervisory authorities, the voluntary participation of the manufacturer and the fact that the site is technically capable of supporting the distant assessment.
Upon completion of the pilot programme with the assessment of 3-5 establishments, a working group will submit a report to the ICMRA Executive Committee summarising the results of the pilot programme with recommendations for implementation, including protocols and reports to be used for conducting hybrid inspections.

Sponsors may apply for this. The institution should make sure that it has a suitable IT infrastructure, that a required interpretation service is available and that it can coordinate with at least two inspectorates in different time zones.

For more information please see the ICMRA website at Pharmaceutical Quality – Regulatory Collaboration Pilots: Call for Industry Applications.

* Collaborative hybrid inspection: the assessment of a facility carried out by more than one national regulatory authority (NRA), using a combination of on-site inspection (by one NRA) and remote inspection (by at least one NRA), linked simultaneously to ongoing activities at the facility via virtual technology.