Life Sciences Newsletter - October 2026

Through Ministerial Resolution No. 927-2026/MINSA, the publication was ordered of the draft Ministerial Resolution approving the evaluation criteria, negotiation procedures, and template bidding documents bidding documents applicable to differentiated acquisition mechanisms (MDA) under a non-competitive procedure, within the framework of Law No. 31336, the National Cancer Law.

The draft aims to establish the provisions necessary for the implementation of differentiated acquisition mechanisms for pharmaceutical products and medical devices intended for the treatment of oncological diseases.

It also sets out the criteria for evaluating suppliers, negotiating contractual terms and conditions, and conducting the corresponding procurement procedures.

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

Through Notice No. 11-2026-DIGESA/MINSA, DIGESA announced that the Official Technical Validations of HACCP Plans that were in force as of June 11, 2026, will remain valid indefinitely for as long as the judicial proceedings initiated following Resolution No. 184-2026/SEL-INDECOPI remain pending. This also applies to validations whose two-year validity period expired after that date.

DIGESA also clarified that validations granted as of October 19, 2026, in connection with new applications or pending proceedings, will be valid for a period of two years.

Through Supreme Decree No. 017-2026-SA, the mandatory notification of administrative acts and/or administrative proceedings under the authority of the Ministry of Health (MINSA) through electronic mailboxes was approved, together with the corresponding Regulations.

The regulation seeks to enhance the efficiency and timeliness of MINSA’s administrative actions through the use of electronic mailboxes, while ensuring the right to proper notification in accordance with due administrative process.

It also provides for the progressive implementation of the electronic mailbox system within a maximum period of ninety (90) calendar days.

Through Decision 970, , the Andean Community extended until October 2, 2031, the entry into force of Decision No. 960, “Regulation on the Registration, Control, Marketing, and Use of Veterinary Products.”

The extension responds to the need to grant Member Countries additional time to adapt their national regulations and adopt the measures necessary to implement the new regulatory framework governing veterinary products.

The Decision establishes the following main provisions:

Through Ministerial Resolution No. 929-2026/MINSA, the supplementary list to the National Single List of Essential Medicines for the Health Sector (PNUME), covering medicines for the treatment of HIV/AIDS and hepatitis, was approved.

The supplementary list incorporates medicines and new therapeutic indications for the treatment of people with HIV and hepatitis. It also establishes the conditions for their use, the levels of care at which they may be prescribed, and the applicable requirements to ensure their rational and safe use.

The medicines incorporated include treatments based on dolutegravir, lamivudine/dolutegravir, darunavir/ritonavir, sofosbuvir/daclatasvir, tenofovir alafenamide, tenofovir alafenamide/emtricitabine, lamivudine/tenofovir disoproxil fumarate/dolutegravir, and abacavir/lamivudine/dolutegravir, as well as the expansion of certain indications for use in adult and pediatric patients and pregnant women.

Through Ministerial Resolution No. 903-2026/MINSA, the Technical Document entitled “Institutional Policy Guidelines for the Safe, Responsible, and Ethical Use of Artificial Intelligence-Based Systems within the Ministry of Health” was approved.

The Technical Document aims to establish guidelines for the safe, responsible, and ethical use of artificial intelligence-based systems within the Ministry of Health, promoting their use in accordance with the protection of fundamental rights, information security, and proper risk management.

It also establishes provisions governing the design, development, procurement, implementation, operation, and oversight of artificial intelligence-based systems within MINSA, incorporating criteria on transparency, human oversight, digital security, personal data protection, and risk management throughout their entire lifecycle.

Through Ministerial Resolution No. D000434-2026-MIDAGRI-DM, the Single Text of Administrative Procedures (TUPA) of the Ministry of Agrarian Development and Irrigation (MIDAGRI) was amended.

The amendment aims to simplify and streamline the administrative procedures and services provided by MIDAGRI, as part of the public administration modernization and administrative simplification initiatives.

The main changes include the elimination of the administrative procedure entitled “Environmental Risk Assessment for the Registration of Agricultural Pesticides”.

Through, Chief Executive Resolution No. D000150-2026-MIDAGRI-SENASA-JN, the Single Text of Administrative Procedures (TUPA) of the National Agrarian Health Service (SENASA) was amended with respect to the administrative procedure entitled “Registration of Animal Feed (excluding feed and medicated feed)”.

The amendment aims to simplify the processing of the aforementioned administrative procedure, in accordance with the principles of legality and administrative simplification.

Accordingly, the requirement to submit a color-scanned image of the draft label for animal feed registration was eliminated from Form IP-01.

SENASA also clarified that this amendment does not alter the labeling requirements applicable to the products or limit its supervisory and enforcement powers regarding compliance with the regulations in force.

Through Decreto Supremo No. 016-2026-SA, several articles and Annex No. 1 of the Regulations of Law No. 28189, the General Law on the Donation and Transplantation of Human Organs and/or Tissues, were amended.

The amendment aims to improve the detection and diagnosis of brain death, as well as increase the rate of organ donations and transplants in the country.

It also updates the provisions applicable to the determination of death based on neurological criteria, or brain death, by incorporating new criteria for its diagnosis and certification. In addition, it regulates the procedure for establishing brain death in pediatric patients, clarifies the responsibilities of the professionals involved, and amends the Record of Confirmation of Death by Neurological Criteria.

Through Ministerial Resolution No. 921-2026/MINSA, a yellow alert was declared at health facilities nationwide in response to the effects of the El Niño Phenomenon, effective from the date of issuance of the Resolution until June 30, 2027.

The measure seeks to strengthen the health sector’s preparedness efforts in response to the risks associated with the El Niño Phenomenon, taking into consideration the scenarios of heavy rainfall and water deficit identified by the competent technical and scientific authorities.