1. Accelerate the national drug registration process to enable registration of any ARV listed by WHO EOI in around 40 participating countries within 1 year by ensuring that:


FOR PRODUCTS WITH PQ APPROVAL:

  • Company submits for registration in countries requesting use of the CRP (based on PQ approval) and process completed within around 4-5 months (country decisions within 3 months, plus submission processing time)


FOR PRODUCTS THAT HAVE NOT YET RECEIVED PQ APPROVAL:

  • Company submits with USFDA for full approval or tentative approval and process completed
    within 6 months;

  • USFDA approval or tentative approval review shared with WHO for Collaborative Registration Procedure-lite (CRP-lite), a pilot program at first allowing FDA to share up to 5 minimally redacted reviews.

  • Company submits for registration in countries requesting use of the CRP (based on WHO PQ, FDA (CRP-lite) or other SRA review) and process completed in around 4-5 months (country decisions within 3 months, plus submission processing time)

9. For ARVs identified as priority products by PADO and included in WHO EOI, strive to ensure alignment with USFDA on study requirements and approach to dossier review.

10. Increase support for harmonization, convergence, and work-sharing through regional regulatory networks and reactivate the Paediatric Regulatory Network by Q2 2019.

11. Initiate implementation of the agreement with USFDA to facilitate the CRP-lite pilot program of products with USFDA full approval or tentative approval by Q1 2019.

12. Encourage wider use of Collaborative Registration Procedures, in particular by the 21 AIDS Free WG priority countries.

11. USFDA/WHO agreement on CRPlite established and 2 products are being piloted

12. Priority countries actively encouraged to join CRP list

10. WHO Paediatric regulatory network being re-established (Consultation in Dec 2019 will relaunch the group)

9. Efforts to facilitate alignment between the three regulatory bodies (USFDA, EMA, WHO-PQ) continue. A meeting among PQ, EMA, and FDA to align and triangulate is planned for November, and discussions occur regularly on alignment of specific dossiers.

Pharmaceutical companies, SRAs, WHO Prequalification Programme (PQ) and NRAs commit to:

1. Accelerate the national drug registration process to enable registration of any ARV listed by WHO EOI in around 40 participating countries within 1 year by ensuring that:


FOR PRODUCTS WITH PQ APPROVAL:

  • Company submits for registration in countries requesting use of the CRP (based on PQ approval) and process completed within around 4-5 months (country decisions within 3 months, plus submission processing time)

 

FOR PRODUCTS THAT HAVE NOT YET RECEIVED PQ APPROVAL:

  • Company submits with USFDA for full approval or tentative approval and process completed within 6 months;

  • USFDA approval or tentative approval review shared with WHO for Collaborative Registration

  • Procedure-lite (CRP-lite), a pilot program at first allowing FDA to share up to 5 minimally redacted reviews.

  • Company submits for registration in countries requesting use of the CRP (based on WHO PQ, FDA (CRP-lite) or other SRA review) and process completed in around 4-5 months (country decisions within 3 months, plus submission processing time)

13. Share their methodological approaches to acceptability studies (including palatability and ease of administration) and contribute to a repository held by GAP-f partners to guide future investigation of acceptability for paediatric products.

14. Consider the use of the CRP for national registration of pediatric ARV products on PADO, Optimal formulary and Limited use lists.

15. Ensure all drug registration dossiers meet minimum requirements at the time of filing and that responses to specific queries are complete and provided in a timely manner

20. Manufacture new PADO priority pediatric ARV products “at risk” such that the new product is available for supply at time of approval/tentative approval/prequalification, including validation of manufacturing process during regulatory review.

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