Action 12. Reestablish the Paediatric Regulatory network to accelerate national registration and facilitate in-country registration of specific products under the Collaborative procedure established by WHO.

Action 12

The Paediatric Regulatory Network was reactivated in December 2019 and will be used as a platform to facilitate information sharing for registration of paediatric medical products. 

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.

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.

10. The Paediatric Regulatory Network was reactivated in December 2019 and will be used as a platform to facilitate information sharing for registration of paediatric medical products.

 

11. The pilot for collaborative registration procedure for diagnostics was finalised successfully and the proposed first draft of the Collaborative procedure between the World Health Organization (WHO) and National Regulatory Authorities in the assessment and accelerated national registration of WHO-prequalified In Vitro Diagnostics (IVDs) is out for public consultation until 15 July 2020 (https://www.who.int/biologicals/Collaborative_Procedure_for_IVDs_for_PC.pdf?ua=1).

 

CRPlite: the lessons learned from the pilot are being evaluated.

 

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

12. Priority countries actively encouraged to join CRP list

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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17. Develop and implement a sustainable and affordable collaborative registration procedure for diagnostics in 2019 and support national regulatory bodies to make use of it to streamline their national regulatory procedures.

18. Subject to support from donors (see 16 above), reinforce the capacity of its Prequalification of In Vitro Diagnostics programme, so that additional staffing can help to optimise process efficiencies and support transparent and predictable timelines for the review of HIV diagnostic products (in particular EID and VL products, and in alignment with WHO guidance).

19. In order to facilitate reduction of national evaluation studies (see points 9 and 12 above), provide relevant additional information within the public reports of products achieving prequalification status for increased data sharing to countries.

Commitment 17

 

June 2020

The CRP-IVD pilot was implemented in 2019 in 5 countries. The procedure is being further extended in 2020 whereby WHO will be working with 7 countries to support the facilitated registration of HIV self-tests. The CRP-IVDs guidelines are published for public consultation.

Previous

The pilot is ongoing, all 5 pilot countries have signed the CRP agreement with WHO and the manufacturer is filing the submissions in each country. By end of 2019 we will be able to draw conclusions on the experience with the pilot.

 

 

Commitment 18

June 2020

To date no additional resources were made available to PQT/IVD, although discussions following transformation and RPQ relocation study included needed resources and phased prioritization of recruitments. PQDx timelines are transparent; - published a guidance on timelines on their website. 

Previous

Regulators and end-users of IVDs in three sub-regions have been trained:
•    Sub-regional work shop for Anglophone Africa in Arusha (2016)
•    Sub-regional workshop for Francophone Africa in Dakar (2017)
•    Sub-regional workshop for Russophone countries in Minsk (2018)
•    National workshop in Ukraine (2018).

A replacement for a staff who left in 2019 is coming on board in November 2020. Beyond this, any additional resources are subject to approval by DG.

Commitment 19:

 

June 2020

PQ Public reports have been amended and include extensive additional information to assist countries in leveraging PQ assessment outcomes. In Q3 2020 PQT will also split the current Public Report into two reports; the WHOPAR will capture the dossier assessment and performance evaluation outcomes and the WHOPIR will outline the site inspection findings.

Previous

The PQ public report was adjusted to provide more data on performance evaluations. At the next GDWG meeting this will be discussed again and input from GDWG will be sought.