Pharmaceutical Industry Blog

Last Updated: August 23, 2026 TL;DR: The United Arab Emirates regulates medicines through the newly created Emirates Drug Establishment (EDE), a federal authority established under Federal Decree-Law No. 38 of 2024 that took over nearly all pharmaceutical registration, import/export permitting, GMP/GDP/GCP certification and pricing functions from the Ministry of Health and Prevention (MOHAP) effective 29 December 2025. Registration through EDE runs on an ICH CTD/eCTD dossier

Last Updated: August 23, 2026 TL;DR: Azerbaijan regulates medicines through the Analytical Expertise Center (AEC), an institution of the Ministry of Health established in 2007 and reorganized as a Public Legal Entity under Order No. 93 of 14 October 2019, which reviews import and marketing applications under a national dossier format (CTD-format submissions are generally reported to be accepted upon prior agreement with AEC). Azerbaijan is not a member of the Eurasian Economi

Last Updated: August 23, 2026 TL;DR: Papua New Guinea regulates medicines through the Pharmaceutical Services Standards Branch (PSSB) of the National Department of Health, which administers the Medicines and Cosmetics Act 1999 and reviews products through a marketing authorization system launched with WHO support in August 2019; a Draft Medicines Bill was under review as of August 2025, following a 2024 WHO Global Benchmarking assessment that made Papua New Guinea the first P

Last Updated: August 23, 2026 TL;DR: Tajikistan regulates medicines through the Ministry of Health and Social Protection of the Population (MOHSPP), which handles state registration, while the State Supervision Service for Health Care and Social Protection of the Population — under MOHSPP — conducts expert evaluation of registration dossiers under Law No. 39 "On Pharmaceuticals and Pharmaceutical Activities," in force since 6 August 2001. Tajikistan is a CIS member but not pa

Last Updated: August 23, 2026 TL;DR: Honduras regulates medicines through the Agencia de Regulación Sanitaria (ARSA), created by Executive Decree PCM-032-2017 in April 2017 as a deconcentrated arm of the Secretaría de Salud and later elevated to full legal standing under Decree 7-2021, which registers pharmaceutical products for human use under the Reglamento Técnico Centroamericano (RTCA) 11.03.59 — the Central American region's harmonized sanitary-registration framework — r

Last Updated: August 23, 2026 TL;DR: Cuba's medicines are regulated by CECMED (Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos), founded April 21, 1989 under the Ministry of Public Health (MINSAP); CECMED issues the Registro Sanitario required before any medicine can be sold domestically, has held WHO Collaborating Centre status for Health Technology since 2014, and is one of only eight PAHO/WHO-designated National Regulatory Authorities of Regi