Pharmaceutical Industry Blog

Last Updated: August 23, 2026 TL;DR: El Salvador is a price-capped, heavily import-dependent market that has just rebuilt its regulator. The Dirección Nacional de Medicamentos, created by the Ley de Medicamentos (Decreto Legislativo No. 1008 of 22 February 2012), was transformed into the Superintendencia de Regulación Sanitaria (SRS) with effect from 7 August 2024. Registration runs under the Central American regulation RTCA 11.03.59:18, adopted by Resolución No. 446-2021 (CO

Last Updated: August 23, 2026 TL;DR: The Republic of the Congo regulates medicines through the Direction de la Pharmacie et du Médicament (DPM), which sits inside the Ministère de la Santé et de la Population and was placed in its current form by Décret n° 2018-286 of 2 July 2018. Market entry runs on an Autorisation de Mise sur le Marché, filed in French, and every consignment then moves through a locally licensed grossiste répartiteur holding a per-shipment import authorisa

Last Updated: August 23, 2026 TL;DR: Paraguay is the market where the second GMP certificate decides everything. Its regulator, the Dirección Nacional de Vigilancia Sanitaria (DINAVISA), is not a department of the health ministry but an autarkic public-law entity constituted by Ley N° 6788 of 23 August 2021 and expanded by Ley N° 7361 of 2024. Under Ley N° 3283/2007 as amended by Ley N° 7256/2024, DINAVISA publishes an annual reference-country list — Resolución DINAVISA N° 18

Last Updated: August 23, 2026 TL;DR: Nicaragua does not write its own medicine registration rules — it applies the Central American regional standard, and that single fact changes the economics of entering the market. Registration runs under RTCA 11.03.59:18, adopted by Resolución No. 446-2021 (COMIECO-XCIV) of 28 April 2021, administered by the Autoridad Nacional de Regulación Sanitaria (ANRS) inside the Ministry of Health, which PAHO placed at maturity level two on the WHO

Last Updated: August 23, 2026 TL;DR: Medicines in the Kyrgyz Republic are regulated by the Department of Medicines and Medical Devices under the Ministry of Health (ДЛСиМИ), constituted by Government Resolution No. 227 of 30 April 2020 — not the older Department of Drug Provision and Medical Equipment name still repeated by most consultancies. The governing statute is Law No. 13 of 12 January 2024 on the Circulation of Medicines, amended through 3 November 2025, with the regi

Last Updated: August 23, 2026 TL;DR: Medicines in Libya are regulated from inside the Ministry of Health rather than by a standalone agency: WHO EMRO identifies the Pharmacy Administration and its Registration Department as the country's drug regulatory authority, alongside the Food and Drug Control Centre (مركز الرقابة على الأغذية والأدوية) as the control and inspection body. Registration before marketing has been a legal requirement since Health Law No. 106 of 1973, but the