Pharmaceutical Industry Blog

Last Updated: August 23, 2026 TL;DR: Tunisia regulates medicines through ANMPS (Agence Nationale des Médicaments et des Produits de Santé), the more autonomous authority created in 2023 to take over the historic role of the Direction de la Pharmacie et du Médicament (DPM), with registration running on the CTD format and moving toward mandatory eCTD submission from 2026. Despite a genuine domestic manufacturing base led by companies such as UNIMED and SIPHAT, Tunisia still imp

Last Updated: August 23, 2026 TL;DR: Farbe Firma Pvt Ltd, a WHO-GMP certified sterile injectable manufacturer in Gujarat, India, is positioned to serve Bolivia's pharmaceutical market as demand grows for quality-assured injectables. Bolivia's national regulator, AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud), created under the Ministerio de Salud y Deportes by Supreme Decree No. 2905 in 2016, issues the Registro Sanitario required for any medicine sold in the

Last Updated: August 17, 2026 TL;DR: Burundi's pharmaceutical sector is regulated by the Autorité Burundaise de Régulation des Médicaments à usage humain et des Aliments (ABREMA), created under Decree No. 100/039 of February 2021 and supervised by the Ministry of Public Health, which reviews EAC-harmonized Common Technical Document dossiers submitted in French and issues an Autorisation de Mise sur le Marché (AMM) under Ministerial Ordinance N°630/991 of August 2023. Burundi'

Last Updated: August 17, 2026 TL;DR: Rwanda's pharmaceutical sector is regulated by the Rwanda Food and Drugs Authority (Rwanda FDA), established under Law N°003/2018 and supervised by the Ministry of Health, which reviews Common Technical Document (CTD) format dossiers and issues Marketing Authorization before any product can be sold. Rwanda FDA reached WHO Global Benchmarking Tool Maturity Level 3 in December 2024 — one of only a handful of African regulators to do so — and

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