2020 HIV TREATMENT

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.

Updates

Commitment 36

June 2022

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

 

March 2022

  • SAHPRA continues to prioritise the review of all HIV and TB therapies (including paediatric formulations) in line with the national strategy of accelerated access. 

Commitment 37

 

June 2022

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

  • SAHPRA continues to prioritise the review of the HIV paediatric formulations- eg dolutegravir 5 mg and 10 mg dispersible tablets. SAHPRA has registered dolutegravir 5mg and 10mg dispersible tablets through the prioritised review process. SAHPRA has also registered the 4-in-1 granules formulation containing abacavir, lamivudine, lopinavir and ritonavir through the same process. SAHPRA is the first NRA to review and register this formulation.

March 2022

  • SAHPRA continues to prioritise the review of the HIV paediatric medicines- eg paediatric dolutegravir formulations. The aim is to finalise the review of these applications before or end of April 2022. 

2020 TB TREATMENT

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.

Updates

June 2022

  • 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.

 

60 & 61: SAHPRA continues to prioritise the review of all HIV and TB therapies (including paediatric formulations) in line with the national strategy of accelerated access. With regards to TB therapies, SAHPRA has prioritised and registered isoniazid/rifapentine combination, several isoniazid/rifampicin combinations. With regards to HIV therapies, SAHPRA has prioritised reviews and registered several ARV fixed dose combinations including tenofovir/emtricitabine, abacavir/lamivudine, tenofovir/lamivudine/efavirenz, tenofovir/lamivudine/dolutegravir

54,55,56 & 62: SAHPRA continues to apply the reliance pathway (WHO CRP based on PQ or SRA approval or SADC Zazibona CRP) to expedite reviews of TB and HIV medicines including the paediatric formulations.

 

March 2022

  • Action 60 & 61: SAHPRA continues to prioritise the review of all HIV and TB therapies (including paediatric formulations) in line with the national strategy of accelerated access. 

  • Action 54,55,56 & 62: SAHPRA continues to apply the reliance pathway (WHO CRP based on PQ or SRA approval or SADC Zazibona CRP) to expedite reviews of TB and HIV medicines including the paediatric formulations.