Pharmaceutical Industry Blog

Last Updated: August 29, 2026 TL;DR: Uruguay is a small, rich, heavily insured market with an unusually specific barrier for Indian manufacturers, and it is not the one most suppliers talk about. Decreto 18/020, as amended in November 2023, requires importers to prove GMP compliance for every manufacturing site through a certificate issued by a regulator that is an ICH MEMBER or a PAHO/WHO Regional Reference Authority — and India's CDSCO is an ICH Observer, not a Member, and

Last Updated: August 29, 2026 TL;DR: Mongolia has a genuine fast-track registration route, and an Indian manufacturer cannot use it. Under the last published version of the registration procedure, the accelerated pathway is reserved for products manufactured in, and approved by, a named list of thirteen “stringent regulatory authorities” built on ICH membership — and India's CDSCO is not among them. What is open is the ordinary route, which asks for registration in the countr

Last Updated: August 28, 2026 TL;DR: Eritrea is one of the least documented medicines markets in the world, and the honest starting point is to say so. There is essentially one paragraph of public description of how medicines are registered there – an undated summary on the African Medicines Regulatory Harmonisation country page – and it tells you two useful things: a first submission to the National Medicines and Food Administration is treated as a new application, and a man

Last Updated: August 28, 2026 TL;DR: Georgia is famous for a seven-working-day medicines registration, and for an Indian manufacturer that headline is the wrong one to read. The Law on Medicines and Pharmaceutical Activities creates two separate routes: a recognition regime, which unilaterally accepts approvals from a fixed list of foreign regulators and skips the scientific assessment entirely, and a national regime, which is a full technical review. The recognised list is s

Last Updated: August 27, 2026 TL;DR: Panama rewrote its medicines law in 2024 and a lot of the advice in circulation is now out of date. Ley 419 de 2024 replaced Ley 1 de 2001 and, unusually, regulates medicines and the public procurement of medicines in a single statute; Decreto Ejecutivo No. 27 de 10 de mayo de 2024 implements it. Registration sits with the Direccion Nacional de Farmacia y Drogas, is filed as a fully digital file, must be lodged by a Panamanian lawyer with

Last Updated: August 27, 2026 TL;DR: Mauritania imports essentially all of its medicines, and the route in is narrower and more specific than most exporters expect. A marketing authorisation, the Autorisation de Mise sur le Marche, is granted by the Minister of Health under Loi n° 2004/036 and is valid for five years; the same law carves out a separate, fee-exempt registration procedure for essential medicines selected through public tender, which is the door most volume actu