Pharmaceutical Industry Blog

Last Updated: August 17, 2026 TL;DR: Benin's pharmaceutical sector is regulated by the Agence béninoise du Médicament et des autres produits de Santé (ABMed), established under Décret n°2023-422 of July 2023 and governed by Loi n°2021-03, which reviews human medicine dossiers in CTD (Common Technical Document) format as mandated by UEMOA Regulation N°04/2020/CM/UEMOA and files them in French. Benin is not a PIC/S member and has not yet published a WHO Global Benchmarking Tool

Last Updated: August 17, 2026 TL;DR: Guinea's pharmaceutical sector is regulated by the Direction Nationale de la Pharmacie et du Médicament (DNPM) under the Ministry of Health and Public Hygiene, operating under Guinea's first comprehensive pharmaceutical law in 24 years, Loi L/2018/024/AN of June 2018, which requires every medicine to hold a ministerial Autorisation de Mise sur le Marché (AMM) before it can be sold or distributed. Guinea is not a PIC/S member and has not ye

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