Snapshot

The Expert Review Panel (ERP) pathway has been developed by the of WHO.

This pathway can be used where The Expert Review Panel is a group of independent experts that reviews the potential risks and benefits associated with the use of finished pharmaceuticals, in vitro diagnostic or medical devices and makes recommendations to procurers on their use. The World Health Organization (WHO) is in charge of selection of the experts and hosts the panel. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is ERP is a service to procurement or funding agencies. ERP does not interact directly with applicants/manufacturers. This is in contrast to the way in which a regulatory function such as WHO prequalification or a stringent regulatory authority operates (SRA). Instead, communication with applicants is handled by the procurer, including receipt of dossiers, communication of the ERP review outcome, and receipt of any responses from the applicant. ERP clients are expected to have a clearly defined quality assurance (QA) policy that indicates under which conditions ERP-reviewed products, in the absence of stringently approved products, are to be procured (In other words, ERP can only ever be one element in the QA policy of a procurement agency). The policy should state that ERP-reviewed products are to be procured only on a time-limited basis, during which time the products are expected to progress in a stringent regulatory pipeline, such as WHO prequalification, or stringent regulatory review, with concomitant improvements in quality. ERP reviews are primarily performed on the basis of dossier information compiled by the manufacturer using the interagency product questionnaire, which is widely used among the UN and other international procurement agencies. In addition, ERP reviewers have access to the relevant product dossiers submitted for WHO prequalification. The review of each ERP dossier involves two assessors, the second assessment is a quality assurance review. Before providing the review outcome to the procurer, all ERP reports are reviewed by a dedicated assessor to ensure consistency in assessment and consistency in the application of risk categorization criteria. ERP reviews available information and identifies deficiencies in each product dossier. The impact of each deficiency on the quality, safety and efficacy of the product is assessed in the context of the intended use of the product, duration of use, as well as product specific attributes such as formulation, specification, stability, bioequivalence and release profile. The product is then allocated to one of four risk categories based on the extent and perceived impact of observed deficiencies. Depending on the number of submissions, ERP may review products in pre-planned sessions, or ad-hoc, as requested by the procurer. ERP can review a few dossiers within days. But for a larger number of dossiers, ERP typically reports its findings within six weeks from the date it received the dossiers from the procurement agency. .