Life Sciences Newsletter - August 2025
Themes
INTERCHANGEABILITY – SECOND LIST OF MEDICINES SUBJECT TO THERAPEUTIC EQUIVALENCE
Through Ministerial Resolution 517-2025-MINSA, the Ministry of Health (MINSA) approved the second list of drugs subject to the requirement to submit therapeutic equivalence studies to demonstrate their interchangeability, as well as the list of reference products to be used as comparators in those studies. The list includes 41 active ingredients and their respective comparators.
This list was approved under the Regulation governing the interchangeability of medicines, approved by Supreme Decree No. 024-2018-SA. This regulation establishes that DIGEMID will determine the gradual implementation of therapeutic equivalence studies (in vivo and in vitro) and will define the reference products to be used as comparators in conducting such studies.
INDUSTRIAL USE OF HEMP - DRAFT REGULATION
Ministerial Resolution 0319-2025-MIDAGRI published the draft Regulation of Law 32195, Law on the agricultural development of hemp for industrial use.
This draft regulation sets out the requirements and procedures for obtaining the necessary authorizations to carry out industrial activities with hemp, within the framework of Law 32195.
The authorizations provided for in the draft regulation are as follows:
- Authorization for the production of hemp for industrial purposes.
- National Registry of hemp processing companies.
- Authorization for the manufacture and marketing of hemp-derived cosmetic products.
- Authorization for the marketing of hemp-derived cosmetic products.
- Authorization for the production of hemp-derived food and beverages.
The deadline for submitting comments on the draft regulation is November 20, 2025. Comments can be sent to ley32195canamo@midagri.gob.pe
TELESALUD – MANDATORY ELECTRONIC MEDICAL RECORDS
Through Ministerial Resolution No. 553-2025/MINSA, the Ministry of Health mandated the implementation of the Electronic Medical Records Information System (SIHCE) in MINSA and regional government primary care facilities.
- For MINSA facilities, the use of SIHCE will be mandatory from the day after the publication of the regulation.
- For regional government facilities, implementation will be gradual, with a maximum period of one year.
- The use of SIHCE by public and private entities in the health sector is authorized, subject to a favorable technical opinion and the signing of an inter-institutional agreement.
- The General Office of Information Technology will be responsible for supervising and conducting the implementation.
The measure seeks to standardize digital clinical records, strengthen the interoperability of the health system, and improve the management of clinical information at the primary care level.
PHARMACIES AND DRUGSTORES – REQUIREMENTS FOR TECHNICAL STAFF MODIFIED
Supreme Decree 015-2025-SA amended Article 43 of the Regulations on Pharmaceutical Establishments. This article stipulated that technical staff in pharmacies and drugstores must have a degree. Now, following this amendment, technical staff in pharmacies and drugstores may alternatively have a degree or a certificate of completed studies accrediting them as pharmacy technicians. This amendment “relaxes” the requirements for technicians in pharmacies and drugstores.
In addition, the Supreme Decree amended, in the same vein, the offense corresponding to the obligation for technical staff in pharmacies and drugstores to have either a degree or a certificate of completed studies accrediting them as pharmacy technicians.
It should be noted that, regardless of this amendment, technical staff retain the authority to perform sales activities, while only pharmacists may perform dispensing activities. These powers have not been modified.
NATIONAL LIST – NEW ONCOLOGY MEDICINES INCLUDED
Ministerial Resolution 543-2025/MINSA approved the Supplementary List of Medicines for the Treatment of Oncological Diseases to the Single National List of Essential Medicines (PNUME).
HIGH-COST ONCOLOGY PRODUCTS – DRAFT REGULATION
Through Executive Presidency Resolution 113-2025-INS/PE, the INS published the Draft Resolution approving the Health Directive: Methodology for Multicriteria Evaluation to generate recommendations for the Use of High-Cost Oncology Health Technologies.
The purpose of this draft directive, within the framework of the National Cancer Law (Law No. 31336), is to establish the methodology of the National Health Technology Assessment Network (RENETSA) in conducting Health Technology Assessments requested for oncological pharmaceutical products not included in the Single National List of Essential Medicines (PNUME) or its complementary lists, or medical devices that are necessary for the treatment of oncological diseases.
The deadline for comments on the draft directive is September 6, 2025. Comments can be sent to contactorenetsa@ins.gob.pe
DIGEMID – BPM CERTIFICATION IN BRAZIL, CHINA, INDIA, AND PANAMA
FOOD – DIGESA TO IMPLEMENT DIGITAL RECORD FOR PRODUCTION INSPECTION
Through Directorial Resolution D000322-2025-DIGESA-MINSA, DIGESA approved the simplified record for risk-based inspection, applied in the health surveillance of industrially processed foods – ACTA IBR. This digital record will be used in health inspections at manufacturing establishments to verify and evaluate, both digitally and in person, the health controls of production processes.