Pharmaceutical Industry Blog

Last Updated: September 4, 2026 TL;DR: Equatorial Guinea answers the question we always ask first — does the country keep a list of regulators it will rely on, and is India on it — with no list at all, because its gate is a certificate test rather than an agency test. Ley del Medicamento 3/2003 requires every imported lot to be lodged with the Ministry of Health and Social Welfare with its invoices and a quality certificate under the WHO certification scheme, or failing that

Last Updated: September 4, 2026 TL;DR: Guinea-Bissau answers the question we always ask first — does the country keep a list of regulators it will rely on, and is India on it — with no published list and a national procedure we could not read. The law that binds it is not national at all: it is the West African Economic and Monetary Union's Règlement 04/2020/CM/UEMOA, which replaced the 2010 regulation and prescribes a five-module CTD dossier, a five-year marketing authorisat

Last Updated: September 4, 2026 TL;DR: Lesotho answers the question we always ask first — does the country keep a list of regulators it will rely on, and is India on it — with no list at all, and with a regulator that is still being built. The Lesotho Medicines and Medical Devices Control Authority Act of 2023 was brought into operation on 1 March 2026, replacing the 2008 framework, and the new authority is reported to be awaiting its regulations; no medicines register, guide

Last Updated: September 4, 2026 TL;DR: Botswana answers the question we always ask first — does the country keep a list of regulators it will rely on, and is India on it — with a reliance pathway that visibly exists and a list we could not read. The Botswana Medicines Regulatory Authority, BoMRA, created under the Medicines and Related Substances Act of 2013, opened a reliance-based expedited registration window for veterinary products in May 2026 and says it is building a Bo

Last Updated: September 3, 2026 TL;DR: Gabon answers the question we always ask first — does the country keep a list of regulators it will rely on, and is India on it — with no list at all. The new Agence Nationale du Médicament et des Autres Produits de Santé, created by ordinance in October 2023 and given its statutes in January 2025, publishes a single dossier checklist for the Autorisation de Mise sur le Marché Gabonais and no reliance or abridged pathway; its guidelines

Last Updated: September 3, 2026 TL;DR: The Gambia answers the question we always ask first — does the country keep a list of regulators it will rely on, and is India on it — with three lists at three layers, and India appears on none of them by name. The Medicines Control Agency's 2023 reliance policy names the EMA, the EU and EEA authorities, the MHRA, the US FDA, PMDA, Swissmedic, Health Canada, the TGA, WHO prequalification, AVAREF, ECOWAS and PIC/S, plus any authority the