Pharmaceutical Industry Blog

Last Updated: August 23, 2026 TL;DR: Sierra Leone's medicines regulator is the Pharmacy Board of Sierra Leone (PBSL), re-established under the Pharmacy and Drugs Act 2001, ISO 9001:2015 certified since 2019 and operating a complete guideline suite from PBSL-GL-001 to PBSL-GL-040 published in 2025. A foreign manufacturer must appoint a locally incorporated agent licensed by PBSL to import, file a Common Technical Document dossier aligned to WHO prequalification and ICH format

Last Updated: August 23, 2026 TL;DR: Belarus registers medicines through RUE «Centre for Examinations and Tests in Health Service» (CETH) under the Ministry of Health, while GMP and EAEU-GMP inspections and the Certificate of a Pharmaceutical Product are handled by Gosfarmnadzor, the State Pharmaceutical Supervision institution that hosts the Ministry's Pharmaceutical Inspectorate. Since 1 January 2021 new products are registered under Eurasian Economic Union rules using the

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