36. Continue to apply priority review of all HIV therapies in alignment to the national strategy of accelerated access.

37. Conduct priority review for priority HIV paediatric medicines (as defined in the PADO List), for example for paediatric DTG formulations.

-

54. Expand use of the Collaborative Registration Procedure based on PQ or SRA approval to expedite national review of paediatric TB drugs and formulations.

55. Use the Paediatric Regulatory Network for advocacy of use of the Collaborative Registration Procedure and to explore models of regulatory reliance to promote equitable access to paediatric TB formulations. 

56. Expedite and simplify the review of priority paediatric formulations including by:

  • Making better use of sub-regional collaborative regulatory approval processes and the WHO Collaborative Registration Procedure for accelerated registration;

  • Increasing reliance on evaluations and opinions of SRAs and the WHO PQ programme.

 

57. End requirements for local clinical trials when sufficient PK and safety data exists, even when no equivalent innovator product exists.

 

58. Minimize/remove country-specific packaging and labelling requirements for paediatric formulations.

 

60. Continue to apply priority review of all TB drugs in alignment with the national strategy

61. Conduct priority review for priority TB paediatric medicines (as defined in the TB PADO List).

62. Use reliance approaches and collaborative regulatory review processes, including WHO Prequalification and “Zazibona,” a sub-regional collaborative platform that allows joint review to expedite the review of TB drugs.

-