Pharmaceutical Industry Blog

Last Updated: September 6, 2026 TL;DR: Cyprus is an EU member state, and that makes it a different animal from every market this series has covered. The question is not whether India is on a reference list — there is no such list to be on. It is who holds the marketing authorisation and who certifies the site. The EU's published mutual recognition partners for GMP are Australia, Canada, Israel, Japan, New Zealand, Switzerland and the United States; India is not among them. Ar

Last Updated: September 6, 2026 TL;DR: Timor-Leste answers the question we ask of every market — does it name the regulators it will lean on, and is India's CDSCO among them — with a named list on which CDSCO does not appear. The list is a route switch, not a bar: question E1 of the DNFM's registration form names ten agencies plus WHO prequalification, yes sends the file to Route A and no sends it to Route B, and both branches end in a registration number. Two harder facts fr

Last Updated: September 5, 2026 TL;DR: Trinidad and Tobago 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 layered lists, India on none of them, and Indian factories nonetheless the largest source of the medicines it registers and buys. The Food and Drugs Regulations of 1964 name Canada, the United States, the United Kingdom and Australia plus a ministerial-discretion clause; the Chemistry,

Last Updated: September 5, 2026 TL;DR: Bahrain 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 clear yes and a clear no. The National Health Regulatory Authority's Medicine Licensing Guideline of 20 October 2025 names six fast-track reference authorities (the Gulf Health Council's central registration, SFDA, US FDA, EMA, Swissmedic and MHRA), a second list on its application form, a third list

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