Pharmaceutical Industry Blog

Last Updated: August 17, 2026 TL;DR: Ecuador's medicines are regulated by the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA), which formally adopted the ICH Common Technical Document format for human pharmaceutical registration under a new Normativa Técnica Sanitaria Sustitutiva published in Registro Oficial No. 731 on 28 January 2025, alongside a parallel biologics regulation in Registro Oficial No. 726. Ecuador is not a PIC/S member, so WHO-format do

Last Updated: August 17, 2026 TL;DR: Guatemala regulates medicines through the Ministerio de Salud Pública y Asistencia Social (MSPAS), specifically its Departamento de Regulación y Control de Productos Farmacéuticos y Afines (DRCPFA), under Decreto Gubernativo No. 712-99 and the Reglamento Técnico Centroamericano (RTCA), the harmonized dossier framework Guatemala shares with El Salvador, Honduras, Nicaragua and Costa Rica. Guatemala is not a PIC/S member, so approval leans o

Last Updated: August 17, 2026 TL;DR: Senegal's pharmaceutical market is regulated by the Agence sénégalaise de Réglementation Pharmaceutique (ARP), created in 2022 (Decree No. 2022-824) and formalized under Law No. 2023-06, which absorbed the former Direction de la Pharmacie et du Médicament (DPM). In December 2024, ARP became the first Francophone African regulator to reach WHO Maturity Level 3, though Senegal, like the rest of West Africa, is not a PIC/S member. As a WAEMU/

Last Updated: August 17, 2026 TL;DR: Somalia's pharmaceutical oversight is administered by the National Medicines Regulatory Authority (NMRA), operating under the Federal Ministry of Health & Human Services as an Interim NMRA since 2023, built on the 1989 pharmacy law and the 2014 National Medicines Policy, with a roadmap benchmarked against WHO's Global Benchmarking Tool. Somalia has not yet achieved a formal WHO maturity rating and sits outside PIC/S, so import approval in

Last Updated: July 29, 2026 TL;DR: Chile registers medicines through the Instituto de Salud Pública (ISP) under Decreto Supremo N°3 of 2010, using a five-module CTD dossier formally adopted in 2020, with a standard legal-evaluation timeline of roughly five to six months that can shorten to about three months for products already approved by a recognised high-surveillance authority. Chile is not currently a member, applicant or pre-applicant of the PIC/S GMP cooperation scheme

Last Updated: July 29, 2026 TL;DR: Kazakhstan registers medicines through the Eurasian Economic Union's unified procedure, mandatory for new dossiers since January 2021, using an EAEU Common Technical Document format reviewed by a reference-state authority together with one or more recognition states, typically inside a ceiling of roughly 300 calendar days. In April 2026 the World Health Organization designated Kazakhstan a Maturity Level 3 regulatory authority, the first in