Pharmaceutical Industry Blog

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

Last Updated: September 2, 2026 TL;DR: Jamaica answers the question we always ask first — is there a list of regulators the country relies on, and is India on it — in a way no market in this series has quite matched: the regulation has no list, the procurement agency has one, and the regional reliance mechanism has another. The Food and Drugs Regulations of 1975 contain no reliance or abridged pathway at all; a new drug needs a certificate from the competent authority of the

Last Updated: September 2, 2026 TL;DR: Armenia is the first market in this series where the question we always ask first — does the country keep a list of regulators it will rely on, and is India on it — has to be answered twice, once nationally and once for the Eurasian Economic Union. Nationally, the simplified 31-day route under the Law on Medicines is keyed to products registered by a member country of the ICH or PIC/S, or prequalified by the WHO. India's CDSCO is an ICH