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Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening.
Mashingia, Jane; Ngum, Nancy; Ndomondo-Sigonda, Margareth; Kermad, Adem; Bujar, Magda; Salek, Sam; Walker, Stuart.
Afiliación
  • Mashingia J; East African Community Secretariat, Arusha, Tanzania.
  • Ngum N; School of Life and Medical Sciences, University of Hertfordshire, United Kingdom; African Union Development Agency- New Partnership for Africa's Development (AUDA-NEPAD), Johannesburg, South Africa.
  • Ndomondo-Sigonda M; African Union Development Agency- New Partnership for Africa's Development (AUDA-NEPAD), Johannesburg, South Africa.
  • Kermad A; Centre for Innovation in Regulatory Science, London, United Kingdom.
  • Bujar M; Centre for Innovation in Regulatory Science, London, United Kingdom.
  • Salek S; School of Life and Medical Sciences, University of Hertfordshire, United Kingdom; Institute for Medicines Development, United Kingdom. Electronic address: sssalek52@gmail.com.
  • Walker S; School of Life and Medical Sciences, University of Hertfordshire, United Kingdom; Centre for Innovation in Regulatory Science, London, United Kingdom.
Regul Toxicol Pharmacol ; 140: 105383, 2023 May.
Article en En | MEDLINE | ID: mdl-36933643
BACKGROUND: Seven national medicines regulatory authorities in the East African Community (EAC) have embraced regulatory reliance, harmonization and work sharing through the EAC Medicines Regulatory Harmonization programme. Measuring the performance of regulatory systems provides key baseline information to build on regulatory system-strengthening strategies. Therefore, the aim of the study was to evaluate the regulatory performance of the EAC joint scientific assessment of applications approved between 2018 and 2021. METHODS: Utilising a data metrics tool, information was collected reflecting timelines for various milestones including submission to screening, scientific assessment and communication of regional recommendations for biologicals and pharmaceuticals that received a positive regional recommendation for product registration from 2018 to 2021. RESULTS: Several challenges as well as possible solutions were identified, including median overall approval times exceeding the EAC 465-day target and median times to issue marketing authorisation following EAC joint assessment recommendation that far exceeded the 116-day target. Recommendations included establishment of an integrated information management system and automation of the capture of regulatory timelines through the EAC metric tool. CONCLUSIONS: Despite initiative progress, work is required to improve the EAC joint regulatory procedure to achieve regulatory systems-strengthening and ensure patients' timely access to safe, efficacious and quality medicines.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Medicina Estatal / Aprobación de Drogas / Regulación Gubernamental / Agencias Gubernamentales País/Región como asunto: Africa Idioma: En Revista: Regul Toxicol Pharmacol Año: 2023 Tipo del documento: Article País de afiliación: Tanzania Pais de publicación: Países Bajos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Medicina Estatal / Aprobación de Drogas / Regulación Gubernamental / Agencias Gubernamentales País/Región como asunto: Africa Idioma: En Revista: Regul Toxicol Pharmacol Año: 2023 Tipo del documento: Article País de afiliación: Tanzania Pais de publicación: Países Bajos