Pharmaceutical Industry Blog

Last Updated: August 23, 2026 TL;DR: Lebanon imports roughly 70% of its medicines and registers every one of them at the Ministry of Public Health, where a Drug Registration Technical Committee reviews files built in CTD structure and a named Lebanese agent must appear in Module 1. Price is set as part of the marketing authorisation against a basket of seven European and seven Middle Eastern reference countries plus the country of origin, and imported generics are capped at u

Last Updated: August 23, 2026 TL;DR: Singapore is one of the most demanding pharmaceutical markets in Asia and one of the most rewarding to get right. The Health Sciences Authority (HSA) regulates therapeutic products under the Health Products Act 2007 and the Health Products (Therapeutic Products) Regulations 2016, was designated a WHO-Listed Authority for its medicines regulatory system on 26 October 2023, and had already attained WHO Maturity Level 4 in January 2022. For a

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