WHO consults on collaborative registration procedures guideline

The World Health Organization (WHO) has released a draft version of its updated guideline on practices for national regulatory authorities’ (NRAs) implementation of collaborative registration procedures (CRP) to facilitate the marketing authorization of new medical products within their jurisdictions for products that have either been WHO-prequalified or approved by a stringent regulatory authority.

The goal of the program is to expand access to new treatments in low- and middle-income countries.

The document would update a previous version issued in 2019 by WHO’s Expert Committee on Specifications for Pharmaceutical Preparations (ESCPP) under Annex 6. The revision was triggered by the expansion of the CRP to include prequalified IVDs and to accommodate NRA feedback, said WHO. The feedback suggested that NRAs would benefit from updated guidance featuring more diagrams, flow charts, and “reduced narration.”

WHO states that “it is critical to have clear NRA procedures to support acceleration of the availability of medical products, without compromising their quality, safety and efficacy/performance, as well as providing an opportunity to harmonize dossier requirements and submission expectations.”

The guidance notes that NRAs should define and establish clear registration pathways for products with prior approval from reference SRAs; WHO-prequalified products; and products reviewed through joint reviews or work-sharing initiatives.

In the guidance WHO encourages NRAs to align their regulatory requirements for medical product registrations with international best practices.

“Submissions and documentary evidence should be consistent and they should comply with applicable national legal and regulatory requirements. Collaborative registrations, or reliance approaches, do not substitute compliance with applicable national requirements; however, NRAs are encouraged to update, where applicable, any legal or regulatory requirements in line with international best practices and harmonized requirements,” said WHO. “In case of post – authorization changes the data package should be the same as what has been submitted to PQT [Prequalification Team].”

Inspections and audits to assess compliance with Good Manufacturing Practices (GMPs)/ISO 13485 should use the WHO prequalification team reference or reference NRA inspection report to facilitate the decision.

WHO advises NRAs to leverage a desk-review instead of conducting an on-site inspection to ensure acceptable level of GMPs and QMS compliance was already confirmed by WHO or SRAs.

The guidance also does not recommend preregistration laboratory testing or performance evaluation of submitted samples but does recommend post-registration risk-based testing.

Dossiers should be submitted in the appropriate format, as required by the respective NRAs. For IVDs, the preferred dossier submission should follow the International Medical Devices Regulatory Forum (IMDRF) Table of Contents (TOC) for IVDs. For countries that have not updated their regulation requirements to adhere to the IMDRF ToC, Global Harmonization Task Force (GHTF) Summary Technical Documentation (STED) may be acceptable.

The NRA should communicate its decision within 30 working days to applicant and WHO. The reasons for refusal should be concurrently shared with the applicant and WHO within 90 working days of regulatory review time.

The guidance also includes a process flowchart showing how to register WHO prequalified or SRA approved products under a CRP. It also includes a table showing the different areas of the assessment conducted by the WHO prequalifying team or the SRA. The reviews focused on active pharmaceutical ingredients (APIs), biologicals substances, finished products and IVDs.

The deadline for submitting comments is 13 September.

WHO

WHO consults on collaborative registration procedures guideline

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