Newsletter

Life Sciences Newsletter - July 2025

August 4, 2025

CLINICAL TRIALS AND CANNABIS

Update of procedures in the TUPA

Supreme Decree 010-2025-SA approved the new Single Text of Administrative Procedures (TUPA) of the National Institute of Health (INS).

The INS TUPA contains the requirements, deadlines, and fees related to all clinical trial and cannabis licensing procedures carried out by the INS.

The following procedures have been included:

  • License for Scientific Research on Cannabis Derivatives for Clinical Trials without Cultivation
  • Clinical Trial Authorization
  • Modifications to Clinical Trial Authorization
  • Amendments to the Research Protocol
  • Registration of Research Centers
  • Accreditation of Institutional Research Ethics Committees

DIGEMID

GMP Certification in Argentina, China, India, and Paraguay

Through Ministerial Resolutions 452, 453, 457, 467, 468, 469 -2025/MINSA, DIGEMID officials were authorized to travel to Argentina, China, India, and Paraguay to inspect laboratories for the purpose of granting GMP certification (Good Manufacturing Practices).

DRAFT REGULATION

Use of modeling substances

Ministerial Resolution 486-2025-MINSA published the draft Regulation of Law 31014, which regulates the use of modeling substances in body treatments for aesthetic purposes and defines such procedures as medical acts.

The draft Regulation defines modeling substances as "those injectable fillers or biopolymers, polymers, and related resorbable, biodegradable, or permanent substances used in body treatments for aesthetic purposes, included in the list approved by the Ministry of Health, at the proposal of the General Directorate of Medicines, Supplies, and Drugs (DIGEMID)."

The Ministry of Health will receive comments and recommendations on the draft until Tuesday, August 20, 2025, via email at webmaster@minsa.gob.pe.