Pharmaceutical Industry Blog

Last Updated: September 13, 2026 TL;DR: Cabo Verde's medicines regulator is ERIS, created by Decreto-Lei n.º 03/2019 de 10 de janeiro, which extinguished ARFA — so any guidance naming ARFA is stale. ERIS publishes two reference-entity lists and India's CDSCO is on neither by name. Its only possible entry runs through WHO's maturity-level list, where WHO's scope for CDSCO reads Vaccines (producing). The full dossier route is open, and the recognition rules set WHO GMP equivale

Last Updated: September 13, 2026 TL;DR: Suriname has no standalone medicines agency. Marketing authorisation is granted by the Registratiecommissie der geneesmiddelen, which the Ministry of Health calls a working organ of the Ministry of Health, under an Ordinance of 8 May 1896 that is still operative as amended. Its fast track names eleven countries and four further categories, and India is not among them. The full dossier route stays open — on paper, in Dutch or English, fi

Last Updated: September 12, 2026 TL;DR: Solomon Islands has no medicines register. The Pharmacy and Poisons Act has been in force since 1941 and licenses sellers and premises, not products, so there is no dossier to file. Section 43 makes the British Pharmacopoeia the standard of quality for every medicine sold. What actually binds a consignment is the importer's own licence, the Ministry's tender, and the donor rules attached to malaria and tuberculosis money. Key Takeaways

Last Updated: September 12, 2026 TL;DR: Bhutan rewrote its medicines rulebook seven months ago. The Bhutan Medicines Rules and Regulation 2025 came into force on 21 February 2026 and superseded the 2019 edition, and the regulator has not been the Drug Regulatory Authority since 2022 — it is the Bhutan Food and Drug Authority. Bhutan names the Indian Pharmacopoeia as an accepted standard and trades with India duty-free. What it does not do is give Indian regulatory approval an

Last Updated: September 11, 2026 TL;DR: Guyana names the regulators it leans on — the United States, Canada, the United Kingdom and Australia — and India is not among them. But it leans harder than any other CARICOM state on the Caribbean Regulatory System, which accepts a WHO-prequalified finished product as an eligibility route. Guyana has registered 164 CRS-recommended products since October 2017, against Haiti's five. The door is open; it is simply not the door marked CDS

Last Updated: September 11, 2026 TL;DR: The Comorian rulebook is eight days old. On 3 September 2026 ANAMEV published, for the first time in one place, eleven CTD dossier checklists, the marketing-authorisation form and five governing decisions. A decision is due within 90 days — but the clock starts when fees are paid, and the fee schedule is published nowhere. The commercial route is narrower still: the national list of licensed wholesalers has exactly one entry. Key Takeaw