Pharmaceutical Industry Blog

Last Updated: August 23, 2026 TL;DR: Israel is one of the most demanding regulated markets an Indian sterile-injectable manufacturer can approach, and it is worth being direct about why. Medicines are registered by the Ministry of Health's Pharmaceutical Division under the Pharmacists Ordinance (New Version) 1981 and the Pharmacists Regulations (Preparations) 1986, with quality certification issued by the Institute for Standardization and Control of Pharmaceuticals (ISCP) in

Last Updated: August 23, 2026 TL;DR: Togo regulates medicines through the Direction de la Pharmacie, du Médicament et des Laboratoires (DPML), a directorate of the Ministry of Health rather than an autonomous agency, operating under the 2009 Public Health Code (Loi n° 2009-007 of 15 May 2009). That is changing: a decree creating an autonomous Agence togolaise de régulation pharmaceutique was still under final review at a Kpalimé expert workshop in late July 2026, so DPML rema

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