Pharmaceutical Industry Blog

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

Last Updated: July 28, 2026 TL;DR: Chad imports more than 90% of the medicines it consumes and has no meaningful domestic sterile injectable manufacturing capacity. Registration is administered by the Direction Generale de la Pharmacie, du Medicament et des Laboratoires (DGPML) under the Ministry of Public Health, applying Loi n024/PR/2000 relative a la Pharmacie. As a CEMAC member state alongside Cameroon, Central African Republic, Congo, Gabon and Equatorial Guinea, Chad ha

Last Updated: July 28, 2026 TL;DR: Zambia imports an estimated 80-90% of the medicines it consumes, and India already supplies more than 46% of those pharmaceutical imports by value - yet sterile injectable manufacturing capacity inside the country remains minimal. The regulator is the Zambia Medicines Regulatory Authority (ZAMRA), established under the Medicines and Allied Substances Act No. 3 of 2013, which reviews marketing-authorisation dossiers in CTD format and aligns i

Last Updated: July 27, 2026 TL;DR: Malawi imports more than 90% of the medicines it consumes and has no domestic sterile injectable capacity at all. The regulator is the Pharmacy and Medicines Regulatory Authority (PMRA), created by Act No. 9 of 2019, which replaced the Pharmacy, Medicines and Poisons Board on 1 October 2019. PMRA leans heavily on reliance: full assessment runs 360 days, while the WHO Collaborative Registration Procedure, the stringent-authority reliance rout

Last Updated: July 27, 2026 TL;DR: Sri Lanka is a market of roughly 23.2 million people where the state sector delivers about 95% of inpatient care through 1,209 government health institutions and 90,392 beds, and where India already supplies half of everything on the register. As at 23 July 2026, 3,291 of 6,577 valid NMRA registrations were Indian-made, including 700 of 1,255 injectable registrations. The regulator is the National Medicines Regulatory Authority (NMRA), const