Life Sciences Newsletter - September 2025
Themes
RARE OR ORPHAN DISEASES (ERH)
1. Treatments for RDDs outside the PNUME that allow for therapeutic continuity
Supreme Decree No. 017-2025-SA incorporated the Second Transitional Complementary Provision to the Regulations of Law No. 29698, which declares the treatment of people with rare or orphan diseases (RDDs) to be of national interest and a priority.
This provision temporarily allows the use of drugs and biological products not included in the Single National List of Essential Medicines (PNUME) or its complementary lists, provided that the cost of treatment exceeds the high-cost threshold approved by the Ministry of Health.
The measure aims to ensure continuity of care for patients with HRS who are already receiving such treatments.
2. Draft multi-criteria methodology for evaluating high-cost health technologies in HR
Through Resolution No. 128-2025-INS/PE, the National Institute of Health (INS) published the draft Health Directive proposing a multi-criteria methodology for evaluating high-cost health technologies for the treatment of HRS.
This methodology seeks to establish technical and ethical criteria for recommending the use of drugs, devices, or other technologies in RH, considering factors such as clinical impact, cost, equity, and unmet medical need. The project is in line with the provisions of Regulation No. 29698.
ARTIFICIAL INTELLIGENCE – Regulations for its Ethical and Safe Use in Healthcare
Supreme Decree No. 115-2025-PCM approved the Regulations of Law 31814, which promotes the use of artificial intelligence for the economic and social development of the country. These regulations will come into force 90 business days after their publication.
The regulation will govern the use of artificial intelligence (AI) systems to ensure that they are used in a safe, ethical, sustainable, transparent, replicable, responsible, and inclusive manner.
AI systems that intervene in the following areas are considered high-risk uses:
- Determining access to health services.
- Screening, diagnosis, management, or prognosis of diseases.
- Prioritizing care in emergencies.
- The processing of sensitive personal data, such as that contained in electronic medical records.
The developers or implementers of these systems must ensure algorithmic transparency, clearly informing users about the purpose of the system, its functions, and the type of decisions it can make. In addition, they must establish mechanisms for human oversight of decision-making.
These obligations will be enforceable in the private health sector one year after the publication of the regulation.
TELEHEALTH
1. Mandatory standards for public and private healthcare providers
Ministerial Resolution No. 608-2025/MINSA approved NTS 232-MINSA/DIGTEL/2025, “Technical Standard for Telehealth,” which establishes the quality and safety requirements for the provision of telehealth services nationwide. This standard is mandatory for all Health Service Providers (IPRESS), both public and private.
It should also be noted that medical devices used in telehealth must have a Health Registration granted by DIGEMID, in accordance with the regulations. This requirement applies generally to all medical devices, not exclusively to those used in telehealth services.
2. National plan to implement telemammography in breast cancer screening
Ministerial Resolution No. 614-2025/MINSA approved the Technical Document: Plan for the implementation of telemammography in priority health facilities for the period 2025-2026.
The plan formalizes the progressive rollout of remote mammogram reading and interpretation services, with the aim of expanding the coverage and timeliness of breast cancer screening in the public health system. The strategy is mainly aimed at women between the ages of 40 and 69 and seeks to improve access to timely diagnosis in areas with limited installed capacity.
COSMETICS – Digemid warns about ingredients banned in the EU
Through Communiqué 024-2025, DIGEMID warned about the European Union's ban on the use of the ingredients Trimethylbenzoyl Diphenylphosphine Oxide (TPO) and N,N-dimethyl-p-toluidine (DMPT) in cosmetic products, especially in semi-permanent nail polishes and gels, due to their reclassification as higher-risk substances.
DIGEMID reported that the member countries of the Andean Community are evaluating the available technical evidence to determine possible regulatory measures in the region. In the meantime, it recommended that manufacturers review their formulations, identify alternative ingredients, and consider the recommendations of international lists of cosmetic ingredients, in accordance with Decision 833.
CONTROLLED PRODUCTS – New Format for Narcotics
Through Communiqué 018-2025, DIGEMID announced the update of the Official Narcotics Order Form (FOPE), which will be mandatory nationwide as of September 1, 2025, for the purchase of narcotic drugs.
The updated form is available on DIGEMID’s institutional website.
DIGEMID – GMP Certification in Argentina, China, and India
INTERCHANGEABILITY – Second List of Drugs Subject to Therapeutic Equivalence
The Ministry of Health, through Ministerial Resolution No. 517-2025-MINSA, approved the second list of medicines for which therapeutic equivalence studies must be submitted to demonstrate interchangeability and the list of reference products to be used as comparators in conducting therapeutic equivalence studies. The list includes 41 active ingredients and their comparators.
This list was approved under the Regulation governing the interchangeability of medicines, approved by Supreme Decree 024-2018-SA. This Regulation establishes that DIGEMID will determine the gradual implementation of therapeutic equivalence studies (in vivo and in vitro) to demonstrate interchangeability and will determine the reference products to be used as comparators in conducting therapeutic equivalence studies.
INDUSTRIAL USE OF HEMP – Draft Regulation
Ministerial Resolution No. 0319-2025-MIDAGRI, published the draft regulation of Law No. 32195, Law for 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 No. 32195.
The authorizations proposed 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 cosmetic products derived from hemp.
- Authorization for the commercialization of cosmetic products derived from hemp.
- Authorization for the production of food and beverages derived from hemp.
The deadline to submit comments on the draft regulation is November 20, 2025. Comments may be sent via email to ley32195canamo@midagri.gob.pe.
TELESALUD – Mandatory Electronic Medical Records
Through Ministerial Resolution No. 553-2025/MINSA, the Ministry of Health mandated the mandatory implementation of the Electronic Medical Records Information System (SIHCE) in primary care facilities belonging to MINSA and regional governments.
- For MINSA facilities, the use of the SIHCE will be mandatory starting the day after the publication of the regulation.
- For regional government facilities, implementation will be progressive, with a maximum period of one year.
- The use of the SIHCE is also authorized for public and private entities in the health sector, subject to a favorable technical opinion and the signing of an inter-institutional agreement.
- The General Office of Information Technologies will be responsible for supervising and overseeing the implementation.
The measure seeks to standardize digital clinical records, strengthen the interoperability of the healthcare system, and improve the management of clinical information in primary care.
PHARMACIES AND DRUGSTORES - Requirements for Technical Staff Modified
Supreme Decree No. 015-2025-SA modified Article 43 of the Regulations for Pharmaceutical Establishments. This article previously 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 pharmacy and drugstore technicians.
In addition, this Supreme Decree modified, in the same vein, the violation corresponding to the obligation that technical staff in pharmacies and drugstores must have, alternatively, a degree or a certificate of completed studies accrediting them as pharmacy technicians.
It should be clarified that, regardless of this modification, technical staff have the authority to perform sales activities, while only pharmacists may perform dispensing activities. These powers were not modified.
NATIONAL LIST – New Oncology Drugs Included
Ministerial Resolution No. 543-2025/MINSA approved the Supplementary List of Drugs for the Treatment of Oncological Diseases to the Single National List of Essential Drugs (PNUME).
HIGH-COST ONCOLOGY PRODUCTS – Draft Regulation
Through Executive Presidency Resolution No. 113-2025-INS/PE, the INS published the Draft Resolution approving the Health Directive: Multicriteria Evaluation Methodology for generating recommendations on the Use of High-Cost Oncology Health Technologies.
The purpose of this draft directive, within the framework of the National Cancer Law (Law 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 submitting comments on the draft directive is September 6, 2025. Comments can be sent to contactorenetsa@ins.gob.pe
DIGEMID - BPM Certification in Brasil, China, India and Panama
FOOD – DIGESA to Implement Digital Record for Production Control
Through Directoral Resolution No. D000322-2025-DIGESA-MINSA, DIGESA approved the “Simplified Record for Risk-Based Inspection, Applied to the Health Surveillance of Industrially Manufactured 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.