Newsletter

Life Sciences Newsletter - September 2026

October 1, 2026

MINSA

REORGANIZATION OF MINSA

Through Supreme Decree No. 014-2026-SA, the Ministry of Health (MINSA) was declared to be undergoing reorganization for a period of ninety (90) calendar days.

The measure is intended to assess MINSA's administrative, organizational, and management situation, and to formulate the appropriate reform actions, including a proposal for a new organizational structure. In particular, the reorganization seeks to identify possible duplications, overlaps, gaps, or fragmentation of functions, as well as to strengthen coordination among its organizational units, programs, and affiliated public agencies.

Among its main provisions, the Supreme Decree establishes the following:

  • The Organization and Modernization Office (Oficina de Organización y Modernización), under the General Office of Planning, Budget, and Modernization, must submit, within sixty (60) calendar days, a report on MINSA's administrative, organizational, and management situation.
  • In addition, within ninety (90) calendar days, it must submit a second report containing the reform measures to be implemented and a proposal for MINSA's new organizational structure.
  • The conclusions and recommendations contained in both reports must first be agreed upon with MINSA's Senior Management bodies.

For the time being, the reorganization has an organizational and institutional scope and does not directly amend the applicable health regulations. Nevertheless, the reform measures adopted as a result of this process could subsequently affect the allocation of functions, reporting lines, coordination mechanisms, and the structure of the authorities involved in regulatory proceedings.

MINSA Approves Cybersecurity Regulations

Through Ministerial Resolution No. 763-2026/MINSA, the Technical Document "Information Security and Cybersecurity Policy Guidelines of the Ministry of Health" was approved, repealing Ministerial Resolution No. 431-2015/MINSA, which had approved the previous "Information Security Policy of the Ministry of Health – MINSA."

The Technical Document is intended to help protect MINSA's information assets, ensuring their confidentiality, integrity, and availability, in line with the principles governing digital government, personal data protection, and the digital transformation of the health sector. In addition, the General Office of Information Technology is entrusted with the dissemination, implementation, oversight, and technical support of the referenced document.

ELECTRONIC NOTIFICATIONS

Through Ministerial Resolution No. 830-2026/MINSA, the publication was ordered of the draft Supreme Decree approving the mandatory notification, via electronic mailbox (casilla electrónica), of administrative acts and administrative actions carried out by the Ministry of Health (MINSA), together with its implementing Regulation and its Statement of Grounds (Exposición de Motivos).

The draft is intended to implement mandatory notification via electronic mailbox in the proceedings and administrative actions handled by MINSA. The proposal establishes that the electronic mailbox will be unique, free of charge, and mandatory for users, and regulates its assignment, access, and operation, as well as the validity and effectiveness of notifications made through this means. It further provides that its implementation will be carried out progressively, within a maximum period of ninety (90) calendar days.

The Ministerial Resolution establishes a period of fifteen (15) calendar days for the submission of comments, contributions, or opinions on the proposal.

MINSA Prepares Action Plan in Response to the El Niño Phenomenon

Through Ministerial Resolution No. 790-2026/MINSA, the "Technical Document: Action Plan of the Ministry of Health in Response to the Effects of the El Niño Phenomenon and Associated Hazards 2026-2027" was approved.

The Plan seeks to reduce morbidity and mortality among the population and to ensure the continuity of health care services in the face of the damage that this event may cause. It also contemplates actions aimed at preparing health services, strengthening the capacities of health personnel, and addressing the harm suffered by the affected population.

These include the monitoring of threats and damage to health and to health care facilities, the procurement of pharmaceutical products and medical devices, epidemiological and entomological surveillance, the deployment of mobile infrastructure and response brigades, as well as actions for the rehabilitation of affected health care facilities and the provision of care through telemedicine services.

PESTICIDES

Suspension of 5 Active Ingredients in Pesticides

Through Directoral Resolution No. 015-2026-MIDAGRI-SENASA-DIAIA, the National Agricultural Health Service ("SENASA") ordered compliance with, and implementation of, the ruling issued by the Second Chamber of the Constitutional Court in Judgment No. 1111/2026, rendered in Case File No. 03269-2023-PA/TC, within the scope of SENASA's competence.

Accordingly, the temporary suspension was ordered of the sale, distribution, and use of phytosanitary products containing, as active substances, chlorpyrifos, methomyl, glyphosate, imidacloprid, and clothianidin, when intended for the production of plant-based food for domestic consumption, under the terms established by the Constitutional Court.

NATIONAL PALLIATIVE CARE PLAN

Regulation of the National Palliative Care Plan Approved

Through Supreme Decree No. 015-2026-SA, the Regulation of Law No. 30846, the Law Creating the National Palliative Care Plan for Oncological and Non-Oncological Diseases, was approved.

This regulation sets forth the technical and regulatory provisions for the implementation of the aforementioned Law, with the aim of helping to improve the quality of life of individuals suffering from diseases requiring palliative care, as well as that of their families and support networks.

It further provides that the National Palliative Care Plan shall remain in effect for three years and seeks to ensure the inclusion of palliative care within the National Health System, encompassing, among others, inpatient care, telemedicine, home-based care, mental health care, and support for patients, family members, and caregivers.

NARCOTICS AND PSYCHOTROPIC SUBSTANCES

Lists of Controlled Narcotics and Psychotropic Substances to Be Amended

Through Ministerial Resolution No. 831-2026/MINSA, the publication was ordered of the draft Supreme Decree amending Lists IV B and VI of Annex No. 2 to the Regulation on Narcotics, Psychotropic Substances, and Other Substances Subject to Health Oversight, approved by Supreme Decree No. 023-2001-SA, together with its Statement of Grounds.

Among its main provisions, the draft proposes the following:

  • Add ketamine to List IV B, which covers psychotropic substances subject to prescription by means of a retained simple medical prescription, due to the risk of abuse, diversion to the illegal market, and recreational use identified by the authority.
  • Remove naloxone from List VI of substances subject to health oversight, considering that it is an antidote used in overdose cases that has no potential for abuse and does not create dependence. In this regard, its continued classification as a controlled substance constitutes a barrier to its timely access.

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

DIGESA

VALIDITY PERIOD OF THE OFFICIAL TECHNICAL VALIDATION OF THE HACCP PLAN

Through Notice No. 08-2026-DIGESA/MINSA, DIGESA announced that Official Technical Validations of the Hazard Analysis and Critical Control Points Plan ("HACCP Plan") that were in effect as of June 11, 2026 shall now be of indefinite duration. This follows Resolution No. 0184-2026/SEL-INDECOPI, which upheld Resolution No. 0507-2025/CEB-INDECOPI and declared the imposition of a two (2)-year validity period on such validations to constitute an unlawful bureaucratic barrier.

DIGESA further clarified that no additional formalities are required for Official Technical Validations of the HACCP Plan that were in effect as of June 11, 2026 to be deemed of indefinite duration.

VUCE

FOOD SAFETY NOTIFICATIONS AND ALERTS

Through Supreme Decree No. 011-2026-MINCETUR, the Regulation of Law No. 30860, the Law Strengthening the Single Window for Foreign Trade ("VUCE"), approved by Supreme Decree No. 008-2020-MINCETUR, was amended.

This amendment is intended to incorporate Chapter IX into Title IV, as well as Articles 102 and 103, into the Regulation of Law No. 30860, in order to optimize and expedite the electronic exchange of notifications and alerts among the health authorities with competence over food safety matters.

The main changes include the following:

  • Incorporate the Food Safety Notification and Alert Management System ("SIGESNOT") as a VUCE service, enabling the health authorities to centrally administer and manage food safety notifications and alerts originating from both national and international sources.
  • Allow for the registration and exchange of information and documentation related to such notifications and alerts, as well as interoperability with national and international systems.
  • Facilitate the generation of information, including statistics, reports, and records related to the food safety notifications and alerts managed through SIGESNOT.

SENASA

PROCEDURE FOR DETERMINING EQUIVALENCE FOR THE IMPORTATION OF CERTIFIED SEEDS

Through Directorial Resolution No. D000018-2026-MIDAGRI-SENASA-DIAIA, the provisions governing the procedure for determining equivalence for the importation of the various categories of certified-class seeds were approved, together with the provisions on their homologation, labeling, and marketing within national territory.

The Resolution sets forth the provisions applicable to the procedure through which SENASA determines the equivalence between the categories of imported seeds and the domestic categories, for purposes of their homologation and subsequent marketing within the country.

GMP

CERTIFICATION OF FOREIGN PHARMACEUTICAL LABORATORIES UNDER GMP

Through Ministerial Resolutions 778, 837, 851, 852, 853, 865, 866-2026/MINSA, travel authorizations were granted to DIGEMID professionals to conduct inspections of laboratories in Colombia, Brazil, Argentina, and India, for the purpose of granting GMP certification.