Life Sciences Newsletter - December 2025

The Andean Community prohibits ingredients in cosmetics

The General Secretariat of the Andean Community, through Resolution No. 2548 (effective as of its publication on December 15, 2025), prohibits the use of the ingredients Trimethylbenzoyl Diphenylphosphine Oxide (TPO) and N,N-dimethyl-p-toluidine (DMPT) in cosmetic products marketed in member countries.

The Resolution also stipulates that no new Mandatory Health Notification (NSO) codes shall be assigned, nor shall renewals or approvals be granted for cosmetics containing these ingredients.

For existing products containing TPO or DMPT, it establishes that they cannot be manufactured, imported, distributed, marketed, or sold after the effective date, and orders their withdrawal from the market within a maximum period of 60 calendar days, without the possibility of exhausting stocks or reformulation. Once the deadline has passed, the NSO code is automatically canceled.

In line with this, DIGEMID issued Communiqué No. 039-2025, addressed to manufacturers, importers, drugstores, marketers, consumers, and beauty professionals, reiterating the ban and the withdrawal deadline, and recommending that they review labeling, avoid use, and report incidents or adverse events through official channels.

Digital Hospital: MINSA strengthens telehealth services

Ministerial Resolution No. 947-2025/MINSA approves the initiative called “Digital Hospital” as a model for the provision of specialized remote health services.

Depending on its scope, the “Digital Hospital” will provide, in accordance with the operational capacity of MINSA Móvil, specialized medical teleconsultation, tele-consultation as clinical support for primary care, tele-support for diagnosis (including remote reading of diagnostic aids), and telemonitoring of patients with chronic diseases and/or functional dependence. These services are provided in addition to the physical services offered by MINSA Móvil, seeking to ensure continuity of care.

Food Transportation: MINSA suspends requirements for 180 days and relaxes temperature and record-keeping rules

Ministerial Resolution No. 936-2025/MINSA provided for the temporary suspension (180 calendar days from its publication) of several provisions of NTS No. 234-MINSA/DIGESA-2025 (Health Standard for Food Transportation), with the aim of giving operators time to implement specialized infrastructure or improvements in vehicles and strengthen the application of hygiene manuals.

In addition, the resolution modifies relevant operating rules. Vehicle maintenance and hygiene requirements are specified, temperature criteria for refrigerated and frozen foods are adjusted, and manual temperature records are allowed as an alternative only when no automatic system is available.

Update of technical standards for plastic containers in contact with food and ice cream

Through Directorial Resolution No. 000031-2025-INACAL/DN, INACAL approved new editions of Peruvian Technical Standards (NTP) related to consumer products and repealed previous versions in which they are replaced.

In terms of food safety and quality, the resolution incorporates:

GMP Certification of Laboratories: Deadlinefor formalizing applications after pre-clearance

Ministerial Resolution No. 899-2025/MINSA amends the Administrative Directive for the Certification of Good Manufacturing Practices in National and Foreign Laboratories, with the aim of adjusting the administrative procedure for processing certification.

This regulation establishes that those who have already requested pre-clearance must submit their GMP certification application within 60 calendar days, under penalty of having to restart the procedure in accordance with the current scheme.

Multisectoral Working Group to address operational and regulatory aspects in pharmaceuticals, medical devices, and health services

Ministerial Resolution No. 916-2025/MINSA creates a temporary Multisectoral Working Group, under the authority of MINSA, with the aim of evaluating and making recommendations on issues related to the management and regulation of pharmaceutical products, medical devices, and health products, as well as health services.

Subsequently, Ministerial Resolution No. 945-2025/MINSA amended Ministerial Resolution No. 916-2025/MINSA to adjust its implementation provisions, maintaining the group's focus on reviewing and addressing these issues (operational and applicable sectoral regulations).

DIGEMID grants GMP certificate

Ministerial Resolutions No. 859, 892, 893, 907, and 917-2025/MINSA, authorized trips by DIGEMID officials to conduct inspections of laboratories in Bolivia, China, Ecuador, Malta, and Thailand for the purpose of granting GMP certification.

SENASA extends incentive scheme for payment of fines in coercive collection until July 2026

Chief Resolution No. D000269-2025-MIDAGRI-SENASA-JN approves the extension of the validity of SENASA's “Incentive scheme for the payment of administrative fines,” extending the term provided for in Chief Resolution No. D000174-2025-MIDAGRI-SENASA-JN.

The measure maintains the scheme that seeks to encourage voluntary payment of SENASA administrative fines that are in the process of enforcement.

Appointment of new directors at DIGESA and DIGEMID

The Ministry of Health issued several ministerial resolutions appointing new heads to key departments of the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) and the General Directorate of Environmental Health and Food Safety (DIGESA).