Pharmaceutical Industry Blog

Last Updated: September 1, 2026 TL;DR: Moldova gives the clearest answer this series has produced to the question we always ask first, and the answer is unfavourable but precise, which is worth more than a vague encouragement. Legea nr. 153 of 19 June 2025 defines in its own first article the countries it treats as having the same level of requirements for proving quality, safety and efficacy: the European Economic Area states, the United States, the United Kingdom, Switzerla

Last Updated: September 1, 2026 TL;DR: Namibia does not fit either pattern this series has been finding. It is not a market with a closed reference-country list that excludes India, and it is not a market with no list at all. The gazetted regulation creates the recognition hook in deliberately open language — registration granted by “other medicines regulatory authorities recognised by the Council” — and names nobody. The Council's actual list of recognised authorities lives

Last Updated: August 31, 2026 TL;DR: Qatar is the first market in several we have written up where the answer to the standing question is genuinely favourable. We read the Pharmacy and Drug Control Department’s eCTD submission guidance in full and searched it for reference-country language: there is no reference-country list, no list of recognised regulators whose GMP certificates are accepted, and no eligibility gate keyed to ICH membership. The clauses requiring a GMP certi

Last Updated: August 31, 2026 TL;DR: Puerto Rico is not a sovereign regulatory jurisdiction, and almost everything written about supplying it gets that half-right in a way that costs money. There is no Puerto Rican marketing authorisation to win: medicines are approved by the US FDA under the Federal Food, Drug, and Cosmetic Act, whose definition of “State” includes the Commonwealth, so the entry ticket is an ANDA or 505(b)(2) plus an FDA-inspected plant. But it is equally wr

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