Life Sciences Newsletter - October 2025
Themes
TELEHEALTH
Digital Transformation in healthcare: MINSA approves new Technical Standard on Telehealth
The Ministry of Health approved Ministerial Resolution No. 664-2025-MINSA, which establishes Technical Health Standard No. 235-MINSA/DIGTEL/2025 on Telehealth.
The standard defines the pillars of telehealth (telemedicine, telegestión, telecapacitación, and teleinformación) and introduces obligations such as the use of digital signatures, interoperability with MINSA's SIHCE, and strict protocols for the protection of personal data. It also sets minimum requirements for infrastructure, biomedical equipment, and secure connectivity.
Public and private IPRESSs have 150 business days to comply, under the supervision of MINSA.
Data protection in electronic health records: Security directive
The Ministry of Health publishedMinisterial Resolution No. 673-2025-MINSA, approving Administrative Directive No. 383-MINSA/OGTI-2025, which approves Administrative Directive No. 383-MINSA/OGTI-2025 establishing the Security Document for the Ministry of Health's Electronic Health Record System (SIHCE).
The purpose of the directive is to safeguard the processing of personal data in the SIHCE against security and confidentiality risks. Its overall objective is to protect the confidentiality, integrity, and availability of information.
Its application is mandatory for MINSA bodies and units, MINSA and regional government health establishments, and is applicable to public, private, and mixed first-level establishments that have a current agreement to use the SIHCE. The OGTI-MINSA is empowered to suspend or terminate users in the event of risks or non-compliance.
FOOD
New health framework for food transportation
Technical Health Standard No. 234-MINSA/DIGESA-2025, approved by Ministerial Resolution No. 646-2025-MINSA, establishes the health requirements that must be met by individuals and legal entities engaged in food transportation in Peru.
This regulation applies to industrialized food (bulk or pre-packaged) and cooked food, but excludes fish and aquaculture products, as well as those intended for export.
Regulated activities include transportation to distribution and marketing centers (such as markets, warehouses, and restaurants), collective food services (hospitals, school cafeterias, companies, etc.), bulk food transportation for the food industry, and home delivery.
Operators must comply with the General Principles of Hygiene (PGH), which involves applying Good Handling Practices (BPM), implementing a Hygiene and Sanitation Program (PHS), and training staff in these matters. It is not necessary to obtain the PGH certificate issued by DIGESA.
Enforcement of this standard is the responsibility of municipal authorities, except in cases where transportation is directed to establishments under the jurisdiction of the National Health Authority, in which case supervision will be carried out by DIGESA, DIRESA/GERESA, or DIRIS.
HIGH-COST HEALTH TECHNOLOGIES
Cancer drugs and rare or orphan diseases
The National Health Institute (INS) approved two health directives establishing the “Methodology for multi-criteria evaluation to generate recommendations for the use of high-cost healthcare technologies,” applicable to different areas. These provisions are formalized through:
- Resolution No. 156-2025-INS/PE, approving the Health Directive: “Methodology for multi-criteria assessment to generate recommendations for the use of high-cost oncology health technologies.”
- Resolution No. 143-2025-INS/PE, approving the Health Directive: “Methodology for multi-criteria assessment to generate recommendations for the use of high-cost health technologies for rare or orphan diseases.”
Both directives are intended to provide the National Health Technology Assessment Network (RENETSA) with a regulatory framework to comply with the provisions of Regulation No. 31336 (National Cancer Law) and Regulation No. 29698 (Rare or Orphan Diseases Law).
The methodology establishes technical and ethical criteria for recommending the use of high-cost pharmaceutical products, medical devices, or other health technologies, considering factors such as: disease burden, therapeutic impact, safety profile, level of innovation, equity, unmet need, socioeconomic impact, and cost-effectiveness.
The rules include: the request for health technology assessment (HTA), the methodological process for developing the multi-criteria assessment (HTA-MCA), the determination of therapeutic and economic value, deliberative dialogue, and the issuance of recommendations and a final report.
These guidelines provide predictability in decision-making and clear guidelines to support requests and procedures related to high-cost health technologies for oncological and rare or orphan diseases.
VETERINARY PRODUCTS
New community regime
The Andean Community approved Decision No. 960, which establishes the new community framework for the registration, control, marketing, and use of veterinary products, and Resolution No. 2528 of the General Secretariat, which approves the Andean Technical Manual that develops the details for implementing the authorizations of Decision 960.
The scope of application of the Decision is as follows:
- Applies to the registration and control of natural or legal persons (domestic or foreign) engaged in the manufacture/production, contract manufacturing, semi-manufacturing, importation, storage, and quality control of veterinary products for terrestrial and aquatic animals, as well as to the registration and control of the veterinary products themselves.
- It does not apply to foot-and-mouth disease vaccines, autovaccines, animal feed, phytotherapeutics, homeopathic products, cosmetics, compounded medications, and other similar products.
The Decision establishes that it shall enter into force 12 months after its publication in the Official Gazette. It will enter into force in October 2026. Until then, countries will continue to apply the current Community or national regulations.
With regard to the transitional regime, Decision 960 does not immediately invalidate registrations already granted, but it does set deadlines for compliance:
- Company/manufacturer registrations must be brought into compliance within five years of the implementation of the new regime.
- Product registrations must also be brought into compliance within five years, with the option of a five-year extension.
- If compliance is not achieved within these time frames, the national authority may order cancellation.
Furthermore, the Technical Manual approved by Resolution 2528 is not an optional guide, but rather the mandatory technical implementation of Decision 960. It contains the formats, documentary requirements, inspection criteria, GMP/GLP/GCP standards, and the veterinary pharmacovigilance scheme that licensees must implement.
COSMETICS
Immediate ban on ingredients in Europe
Regulation (EU) 2025/877, known as Omnibus VII, came into force on September 1, 2025, without a transition period, establishing a ban on the use of various CMR ingredients (carcinogenic, mutagenic, and toxic to reproduction) in cosmetic products. This measure is part of the European Union's zero-tolerance policy towards substances that pose serious risks to consumer health.
Among the banned ingredients are TPO (Trimethylbenzoyl Diphenylphosphine Oxide) and DMPT (N,N-dimethyl-p-toluidine), commonly used in semi-permanent nail polish, UV gels, and hair dyes. The immediate entry into force of the regulation requires the reformulation and withdrawal from the market of products containing these substances.
This regulatory change has direct repercussions in the Andean region, given that Decision 833 of the Andean Community of Nations (CAN) recognizes the European lists as a reference for the regulation of cosmetic ingredients.
In this context, DIGEMID, through Communiqué No. 024-2025, reported on the situation and recommended that manufacturers and distributors identify safe alternatives, review labels, reformulate products, and follow the recommendations of international lists.
PHARMACIES
List of prohibited products and services
Ministerial Resolution No. 734-2025/MINSA, approved the list of products and services prohibited in pharmacies, drugstores, health facility pharmacies, and first aid kits.
Among the prohibited products and services highlighted are:
- Medical consultations
- Collection of samples for clinical analysis
- Medical campaigns
- Electronic cigarettes
- Veterinary medicines
DIGEMID
MINSA
New Regulations on Organization and Functions
The Ministry of Health approved Supreme Decree No. 019-2025-SA, which approves Section One of the new Regulations on Organization and Functions of the Ministry of Health.
The main change is that the Regulations on Organization and Functions (ROF) now expressly establish that the Ministry of Health (MINSA) exercises oversight over the entire health system, including the supervision of Social Health Insurance (EsSalud) services, the health services of the Armed Forces and the National Police, as well as health service providers at the national, regional, and local levels. In addition, the functions have been updated in accordance with the current legal basis.
Compared to the previous ROF, some functions that the Ministry of Health was already performing are now explicitly incorporated, such as: the creation of an advisory cabinet for senior management; the expansion of the General Secretariat's powers in the areas of transparency, integrity, digital transformation, and information security; and the implementation of operational tools such as the “MINSA Móvil” application and the suicide prevention registry. This is not an institutional reengineering, but rather an update to the ROF of what was already being implemented under the current legal framework.
This new ROF will come into effect when MINSA approves Section Two by ministerial resolution. Until that happens, the 2017 ROF remains in force.
DRAFTS
Amendment to the Regulation on Drug Interchangeability
The Ministry of Health published, through Ministerial Resolution No. 727-2025/MINSA, the draft Supreme Decree amending the Regulation governing drug interchangeability (Supreme Decree No. 024-2018-SA).
Among the main proposed changes, the following stand out:
- The relaxation of conditions for conducting therapeutic equivalence studies, allowing the use of smaller batches and eliminating restrictions on batch validity.
- The possibility of using innovative products marketed in any country and comparators recognized by international authorities is expanded, even if they are not registered in Peru.
- More detailed criteria are incorporated for drugs that do not require studies, establishing new conditions related to excipients.
The bill is open for public consultation for 90 days to receive comments.
Draft amendment to the Regulations on Toys and Stationery
Ministerial Resolution No. 680-2025-MINSA, publishes the draft Supreme Decree amending the Regulations of Law No. 28376 (D.S. 008-2007-SA) on the manufacture, import, distribution, and marketing of toys and stationery.
The bill proposes substantive changes:
- It redefines “toys” as products for children under 14 years of age and incorporates the concept of “product family.”
- It restructures the registration process for manufacturing, importing, marketing, and/or distributing. The procedure is automatically approved and has an indefinite validity period.
- The health authorization to manufacture/import (toys and supplies) by product or family will be valid for two years and will be automatically renewed unless otherwise specified.
- Creates the “Health authorization for the importation of toys or supplies for use by third parties” to import an already authorized product. It is an automatic approval procedure and its validity is subject to that of the main authorization
DIGESA will receive comments for 90 calendar days.