2. Release an official communication to reflect that the review of Paediatric Investigation Plans (PIP)s, while maintaining that each PIP is evaluated on a scientifically justified case-by-case basis, will continue to ensure that the following points are always considered:
Paediatric formulation development must be integrated from the beginning in the planning and implementation of the overall paediatric drug development starting at least by the time of completion of phase 1 studies in adults taking into account paediatric dose finding and clinical studies;
Adolescents should be included in initial pivotal efficacy and safety trials in adults, or adolescent trials should be conducted in parallel with adults unless otherwise scientifically justified;
When scientifically appropriate studies of drugs across the paediatric spectrum of ages/weights (at least down to the age of 4 weeks) should be conducted in parallel rather than in series (unless a particular product has a specific safety or drug disposition factor that warrants a different approach).
Drug development studies in children should be based on weight rather than age and should align with the WHO weight bands.
3. Work on measures to improve the handling of PIP applications including to facilitate the modification process as agreed in the EMA-EC action plan published in October 2018.
4. Continue to discuss with USFDA prior to and during the review of PSPs and PIPs in order to align on content as much as possible, specifically also for ARV products identified as priority products by PADO.
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.