Life Sciences Newsletter - April 2026

New Packaging Regulation

Through Ministerial Resolution No. 388-2026/MINSA, published on April 18, 2026, the publication of the draft amendment to Article 119 of the “Regulations on Sanitary Surveillance and Control of Food and Beverages,” approved by Supreme Decree No. 007-98-SA, was ordered.

Among the main proposals, the following is provided:

The Ministerial Resolution establishes a period of ninety (90) calendar days for companies to submit comments or observations on the draft.

Approval of the Regulations

Through Supreme Decree No. 005-2026-MINAM, published on April 8, 2026, the Regulations of Legislative Decree No. 1570, the Comprehensive Chemical Substances Management Law, were approved.

This regulation establishes the national regulatory framework for the management of chemical substances throughout their life cycle, under a risk management approach aimed at protecting human health and the environment. It incorporates provisions on hazard classification, labeling, and Safety Data Sheets (GHS), as well as obligations relating to notification, registration, assessment, and enforcement.

It is specified that the regulation does not apply to products governed by special sanitary or sector-specific regulations, such as pharmaceutical products, medical devices, cosmetics, and other products subject to sanitary standards (NSO).

The regulation shall enter into force six (6) months after its publication, with progressive compliance periods for certain obligations.

New DIGEMID

On April 28, 2026, the Health and Population Commission of the Congress of the Republic approved the report issued in connection with Bills 10902/2024-PE, 11091/2024-CR, 11688/2024-CR, 13172/2025-CR, 13227/2025-CR and 13257/2025-CR, which proposes the creation of the Peruvian Authority for Pharmaceutical Products, Medical Devices, and Health Products (APEMED) as a specialized technical public agency attached to the Ministry of Health.

The proposal establishes a new national health authority with legal personality, its own assets, and functional, legal, technical, economic, financial, administrative, and budgetary autonomy. APEMED would assume functions currently exercised mainly by DIGEMID, as well as competencies related to clinical trials currently held by the Clinical Trials Subdirectorate of the National Institute of Health (INS).

The entity would have jurisdiction over pharmaceutical products, medical devices, and health products, including registration, authorization, certification, surveillance, enforcement, sanctioning powers, sanitary control, pharmacovigilance, technovigilance, cosmetovigilance, and clinical and preclinical research. The report also provides for coercive enforcement powers to implement final administrative acts or acts subject to immediate compliance.

The approved committee report does not yet convert the proposal into law. For its definitive approval, the report must be published and included in the agenda of the Plenary of Congress, debated and approved by the Plenary, and pass a double voting process, unless waived in accordance with parliamentary procedure. Thereafter, the approved bill must be submitted to the Executive Branch for enactment or observation.

Prohibition of the Use of Bimatoprost in the Andean Community

Through Resolution No. 2579 of the General Secretariat of the Andean Community, published on April 23, 2026, the use of the ingredient Bimatoprost is prohibited in cosmetic products marketed within the Andean Community.

The decision is based on the fact that the mechanism of action of Bimatoprost is not superficial but systemic, which exceeds the definition of a cosmetic product, in addition to the identification of risks and adverse reactions associated with its use.

In this context, the Resolution prohibits the granting, renewal, and recognition of Mandatory Sanitary Notifications (NSO) for cosmetic products containing such ingredient, as of its entry into force, and establishes a period of one (1) year for operators to reformulate their products, exhaust existing stocks, and amend the corresponding NSO.

Upon expiry of such period, the NSOs of non-reformulated products shall be automatically cancelled, and such products must be withdrawn from the market, without the possibility of extension.

Ethics Committees

Through Executive Presidency Resolution No. 000083-2026-INS/PE, published on April 16, 2026, the “Health Directive for the establishment and registration of Research Ethics Committees in Peru” was approved.

Among its main provisions, the directive regulates the establishment of Research Ethics Committees (RECs) and their registration in the National Registry, setting forth minimum criteria, procedural stages, dissemination mechanisms, and a public information system administered by the National Institute of Health (INS).

Through this measure, the aim is to strengthen the ethical review of health research and enhance coordination among registered committees at the national level.

PRODUCE

Through Ministerial Resolution No. 000109-2026-PRODUCE, published on April 27, 2026, the provisions for the implementation of the Registry of manufacturers, importers, traders, and/or distributors of paints and other coating materials containing lead and lead concentration, within the framework of Law No. 31182, were amended.

The regulation updates the content of the Registry, specifying the minimum required information, as well as the conditions for registration and deregistration, with the purpose of strengthening control mechanisms for the protection of public health.

Good Manufacturing Practices (GMP) Certification

Pursuant to Ministerial Resolutions No. 356, 357, 358, 359, 365, 387, 389, 390-2026/MINSA, the travel of DIGEMID professionals was authorized to carry out inspections of laboratories in India for the purpose of granting Good Manufacturing Practices (GMP) certification.