Life Sciences Newsletter - November 2025

DIGESA and DIGEMID

The Ministry of Health (MINSA), through Ministerial Resolution No. 855-2025/MINSA, appointed José Adalberto Latorre Gálvez as Director General of DIGESA, and Lida Esther Hildebrandt Pinedo as Director General of DIGEMID, through Ministerial Resolution No. 857-2025/MINSA.

Quality Control of the First and Subsequent Batches

Ministerial Resolution No. 793-2025/MINSA, ordered the publication of the draft regulations governing the submission of quality control results for the first and subsequent batches of pharmaceutical products. The draft regulations aim to standardize the technical and procedural requirements that holders of sanitary registrations must meet to demonstrate the quality of batches entering the market.

The draft stipulates that the first batch of a pharmaceutical product must have a quality control report issued by the National Center for Quality Control (CNCC) of the INS or by an official laboratory. For subsequent batches, certificates issued by the manufacturer's own laboratories or by third-party laboratories certified in Good Laboratory Practices (GLP) will be required, and this information must be submitted through the DIGEMID online platform.

The draft includes, as an annex, a detailed list of the critical tests required for each pharmaceutical form, allowing for the standardization of minimum quality control parameters. It also provides for exceptions in cases where the technology to perform certain tests is not available in the country.

The Ministry of Health (MINSA) will accept suggestions, comments, or recommendations on the draft until February 15, 2026.

Creation of the Working Group to Develop the National RHD Plan

Through Ministerial Resolution No. 794-2025/MINSA, a temporary Multisectoral Working Group wascreated, tasked with developing the proposal for the National Plan for the Prevention, Diagnosis, Comprehensive Care, Treatment, Rehabilitation, Research, and Monitoring of Rare or Orphan Diseases (PLANERH). This initiative seeks to provide the country with a strategic instrument that coordinates comprehensive actions for the care of these low-prevalence, high-impact health conditions.

The working group will be comprised of representatives from the health sector, academic institutions, and other sectors involved in the clinical, scientific, and social approach to rare diseases. Its work includes identifying gaps, evaluating existing capacities, formulating measures to improve access to diagnosis and treatment, and proposing monitoring and research mechanisms.

Multicriteria Evaluation Methodology for High-Cost Technologies

The National Institute of Health (INS) approved Executive Presidency Resolution No. 188-2025-INS/PE, which amended Health Directive No. 001-INS/CETS-2025.Vs.01, “Methodology for Multicriteria Evaluation to Generate Recommendations for the Use of High-Cost Health Technologies for Rare or Orphan Diseases.”

The INS modified the methodology for evaluating health technologies for rare diseases, refining criteria regarding clinical evidence, safety, and cost-effectiveness.

Against HPV in Patients with HIV, Tuberculosis, and Immunosuppression

Law No. 32501, published on November 14, 2025, establishes the obligation to prioritize HPV vaccination in people with HIV, tuberculosis, and other immunosuppressive conditions, reinforcing their free and timely access.

Modification of the Andean Technical Regulation on Labeling

Resolution No. 2540 modified Resolution No. 2310, which contains the Andean Technical Regulation for the Labeling of Cosmetic Products. The regulation relaxes certain formal labeling requirements for cosmetics without affecting the health and safety standards required for these products in the Andean subregion.

Among the most relevant changes is the elimination of the requirement to translate certain commonly used generic terms. The use of stickers to adapt labeling information, including cosmetic claims, is also expressly authorized, provided that current health requirements are met. Finally, the resolution specifies that modifications to the labeling related to non-health information, which do not generate a health impact, do not need to be reported to the competent authority.

Modification to RENHICE to Enable Health Research with Anonymized Clinical Data

Supreme Decree No. 020-2025-SA amended Supreme Decree No. 009-2017-SA, the Regulations of Law No. 30024, which created the National Registry of Electronic Medical Records (RENHICE).

This amendment stipulates that academic institutions and other actors conducting scientific research may access properly anonymized clinical data contained in RENHICE. To do so, researchers are required to have a protocol approved by an Ethics Committee accredited by the National Institute of Health (INS), register said protocol, and request the information from the Ministry of Health, which will be responsible for managing the anonymization of the data and ensuring secure access through the National Open Data Platform.

GMP Certification Abroad

Ministerial Resolutions No. 763, 781, 791, 792, 802, 803, 804, 837, 838, 841, and 846-2025/MINSA authorized travel by DIGEMID officials to conduct laboratory inspections in Brazil, India, Mexico, Paraguay, Poland, Singapore, and Turkey for the purpose of issuing Good Manufacturing Practices (GMP) certifications.