Life Sciences Newsletter – May 2025

MEDICINES AND BIOLOGICAL PRODUCTS

Accelerated Procedure for the Sanitary Registration of Medicines and Biological Products

Law 32319 was published. This law establishes measures to facilitate access to medicines and biological products registered in countries with high health surveillance for the treatment of rare and orphan diseases, cancer, and other diseases.

Several points to keep in mind:

• An accelerated procedure is established for granting sanitary registration for certain medicines and biological products previously authorized in high health surveillance countries (PAVS).
• Through this procedure, obtaining sanitary registrations would have a maximum period of 45 calendar days, counted from the day following the registration request.
• The procedure is classified as positive administrative silence.
• Article 9 of Law 29698 is repealed.
• DIGEMID established the characteristics of this procedure through Directorial Resolution 76-2025-DIGEMID-DG-MINSA (Institutional Directive for the processing of registration and re-registration in the health registry submitted within the framework of Law 32319) and Communication 007-2025.

DIGEMID

DIGEMID – GMP Certification in Argentina, China, India, and Mexico

Ministerial Resolutions 338, 337, 333, 321, 320, 319, and 318-2025/MINSA authorized travel for DIGEMID officials to conduct inspections of laboratories in Argentina, China, India, and Mexico for the purpose of granting GMP certification.

NEW LAW

New Wine Law

Law 32320, the Wine Framework Law, was published, establishing that DIGESA will control the health and safety of wine production.

In line with food safety principles, the law stipulates that both the production and bottling of wine must be carried out under the direct responsibility of qualified and certified professionals, thus guaranteeing safe and technically supported processes.

It also establishes that the import of wine products must comply with the international standards defined in the Codex Alimentarius standard CAC/GL 38-2001.

Finally, the law creates the National Viticulture Council (CONAVIT), attached to the Ministry of Production, to carry out promotion, dissemination, and provide technical assistance related to Peruvian wine.