Pharmaceutical Industry Blog

Last Updated: August 17, 2026 TL;DR: Zimbabwe's medicines are regulated by the Medicines Control Authority of Zimbabwe (MCAZ) under the Medicines and Allied Substances Control Act, which reviews human pharmaceutical dossiers in CTD format and reached WHO Global Benchmarking Tool Maturity Level 3 in June 2024 — only the sixth African regulator to do so. MCAZ is not yet a full PIC/S member, having applied for pre-accession in October 2023, so a genuine Certificate of Pharmaceut

Last Updated: August 17, 2026 TL;DR: Cambodia's pharmaceuticals are regulated by the Department of Drugs, Food, Medical Devices and Cosmetics (DDF) under the Ministry of Health, which reviews human medicine dossiers in ASEAN Common Technical Dossier (ACTD) format through CamPORS, the country's paperless online registration portal launched in August 2019. Cambodia is not a PIC/S member, so DDF's review leans on WHO-format evidence — a genuine Certificate of Pharmaceutical Prod

Last Updated: August 17, 2026 TL;DR: Ecuador's medicines are regulated by the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA), which formally adopted the ICH Common Technical Document format for human pharmaceutical registration under a new Normativa Técnica Sanitaria Sustitutiva published in Registro Oficial No. 731 on 28 January 2025, alongside a parallel biologics regulation in Registro Oficial No. 726. Ecuador is not a PIC/S member, so WHO-format do

Last Updated: August 17, 2026 TL;DR: Guatemala regulates medicines through the Ministerio de Salud Pública y Asistencia Social (MSPAS), specifically its Departamento de Regulación y Control de Productos Farmacéuticos y Afines (DRCPFA), under Decreto Gubernativo No. 712-99 and the Reglamento Técnico Centroamericano (RTCA), the harmonized dossier framework Guatemala shares with El Salvador, Honduras, Nicaragua and Costa Rica. Guatemala is not a PIC/S member, so approval leans o

Last Updated: August 17, 2026 TL;DR: Senegal's pharmaceutical market is regulated by the Agence sénégalaise de Réglementation Pharmaceutique (ARP), created in 2022 (Decree No. 2022-824) and formalized under Law No. 2023-06, which absorbed the former Direction de la Pharmacie et du Médicament (DPM). In December 2024, ARP became the first Francophone African regulator to reach WHO Maturity Level 3, though Senegal, like the rest of West Africa, is not a PIC/S member. As a WAEMU/

Last Updated: August 17, 2026 TL;DR: Somalia's pharmaceutical oversight is administered by the National Medicines Regulatory Authority (NMRA), operating under the Federal Ministry of Health & Human Services as an Interim NMRA since 2023, built on the 1989 pharmacy law and the 2014 National Medicines Policy, with a roadmap benchmarked against WHO's Global Benchmarking Tool. Somalia has not yet achieved a formal WHO maturity rating and sits outside PIC/S, so import approval in