DIGEMID: Inspection and international sanitary control of medications in the Peruvian market

The General Directorate of Medicines, Supplies, and Drugs (DIGEMID) by order of the MINSA (The Ministry of Health), carried out an international inspection of laboratories that commercialize medications in the Peruvian market and that count with their respective regulatory certificate.
The procedure of the authorities of The General Directorate of Medicines, Supplies and Drugs obeys their new strategy for the control and compliance of the Good Manufacturing Practices (GMP), by foreign pharmaceutical laboratories that commercialize drugs in Peru.
93 pharmaceutical laboratories in countries of Asia, Europe, and America have been inspected from November 2025 to date.
Regulatory control and of GMP for medications in Peru
24 specialized inspectors of The General Directorate of Medicines, Supplies and Drugs visited laboratories in Argentina, Colombia e IndiaTheir mission was to verify the origin conditions of the drugs that supply the country. The new strategy contemplates initiating the regulatory control of medications in their exact place of manufacture and identifying possible sanitary risks. The objective is to avoid that pharmaceutical products that fail to comply with the GMP reach the population.
Granting of certificates and alignment with international policies
One of the purposes is to align with international policies and contribute to the closure of gaps identified by The Global Benchmarking Tool (GBT), the tool of World Health Organization (WHO) that measures the strength and performance of national regulatory systems for medical products.
From November 2025, a total of 93 pharmaceutical laboratories have been evaluated, evidencing the technical rigor and independence of the evaluations. The certification is granted in function of the effective compliance of the requirements. The results obtained from the evaluation are the following:
- • 36 laboratories obtained the GMP certification.
- • 7 laboratories reached a partial certification.
- • 32 laboratories did not receive the certification due to technical non-compliance.
- • 18 laboratories desisted from the process.
If you liked this note, save the information and share it with a colleague who it may serve. OMC Abogados & Consultores finds itself at your complete disposal if you need advisory regarding regulatory matters or procedures before DIGEMID, , just enter the link: https://omcabogados.com.pe/en/legal-consultation-trademark-patent-in-peru-and-latin-america/

