WHO norms for good review practices to regulatory authorities for pharma & biologicals

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World Health Organisation (WHO) has issued the draft guidance on  Good review Practices (GRevP) for  regulatory authorities(RAs). The comments on these guidelines are expected from all regulatory authorities globally and India too before April end.

The guidelines are for pharmaceutical and biological drugs and high-risk medical devices used  in humans. However, the concepts of these norms could also be applied to other types of medical products, as well as to applications for investigational testing. The objective is to provide high level guidance on GRevP principles and processes, for use across a range of RA requirements. But it is not intended to provide detailed instruction on how to conduct a scientific review,  stated WHO.

The guideline  is envisioned as one building block in a set of tools and is sufficiently expandable to  accommodate additional annexes or ancillary documents in the future. The RAs are increasingly seeking ways to improve their performance and ensure the quality of their  regulatory systems, stated WHO.

GRevPs are an integral part of overall good regulatory practices and focus on the medical product review. Review is a highly complex, multidisciplinary assessment of the medical product applications in meeting scientific and evidentiary standards. It forms the scientific foundation for regulatory decisions.

The extent to which an RA can achieve the review goals of timeliness, predictability, consistency, transparency, clarity, efficiency and high quality can have significant impact on public health , it noted.

Implementation of GRevPs help to achieve these review goals by ensuring those involved in  the review process have the critical thinking skills and tools needed to optimise scientifically sound, evidence-based decisions. It also facilitates progress towards regulatory convergence through the  development of common platforms for exchanging review reports and the enhancement of mutual trust. Several RAs have introduced ways of monitoring and improving their review process  through structured  approaches or moving towards step-wise implementation of GRevPs.

The WHO is now of the view that  RAs should consider review models  and best practices within the context of available resources and legal requirements The GRevP principles  can be adapted to meet the continuous improvement needs of a  diverse range of RAs.

GRevPs are documented best practices for any aspect related to the process, format, content and management of a medical product review. The aim  of GRevPs is to promote the timeliness,  predictability, consistency, transparency, clarity, efficiency and high quality of the content and the  management of reviews. This is done through the development of review tools like  standard operating procedures (SOPs), templates and reviewer learning activities.

To promote continuous improvement, all aspects of GRevPs should be evaluated and updated on an ongoing basis. Further, the document applies to the review of safety, efficacy  and quality data in medical product applications filed with RAs for marketing authorisation.

Regulatory decision-making or recommendations from reviewers should be based on the best current science. In decisions to grant market authorization should be   based  on sound scientific evidence.

Documentation of scientific rationale for decision-making, taking into account regulatory requirements needs to ensure the integrity of the review process. The RA may also have mechanisms for communication with the public on the approval of the product or on  action taken in relation to the application. The guidelines also call for publication of information on the approval of products to increase transparency of regulatory actions, said WHO.

Source: PharmaBiz

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