Life Sciences Newsletter - January 2026
Themes
HUMAN MILK BANKS: REGULATIONS FOR LAW 31633 APPROVED
Through Supreme Decree No. 022-2025-SA, published on January 1, 2026, the Regulations for Law No. 31633 were approved. These regulations establish the framework for the implementation and operation of human milk banks in Peru, with the objective of ensuring access to safe, pasteurized, and wholesome donated human milk for newborns and infants who cannot receive their own mother's milk due to clinical reasons or other maternal conditions.
The Regulations apply to public healthcare facilities and also extend to private and mixed facilities that provide maternal and child health care, establishing a National Network of milk banks and collection centers.
It also establishes key operating criteria related to procurement, processing and pasteurization, quality control, traceability, and confidentiality, and is framed within the context of free distribution and the prohibition of commercialization of human milk.
COLD CHAIN IN IMMUNIZATIONS: MINSA APPROVES NEW TECHNICAL STANDARD AND REPEALS 2017 REGULATION
Through Ministerial Resolution No. 074-2026/MINSA, MINSA approved NTS No. 242-MINSA/DGIESP-2026 “Technical Health Standard for Cold Chain Management in Immunizations,” which updates the procedures for the storage, handling, transport, and distribution of vaccines for human use. The standard was issued due to the need to replace the previous framework, which was considered outdated in light of technological and operational advances, and its purpose remains to support the control and elimination of vaccine-preventable diseases through uniform technical standards for the cold chain.
The NTS is mandatory for public sector entities at all levels and also for private institutions that carry out activities related to the storage, handling, transport, distribution of vaccines, and vaccination. Within this framework, it establishes criteria for the management and control of the cold chain, including temperature monitoring, contingency measures in the event of failures, and guidelines for the maintenance and operation of the equipment used to ensure adequate storage conditions.
Finally, the Resolution repeals Ministerial Resolution No. 497-2017/MINSA, rendering the previous technical standard on the cold chain in immunizations null and void.
CANCER OVERSIGHT: MINSA SUBMITS DRAFT REGULATIONS FOR LAW 32357 TO PUBLIC CONSULTATION
Through Ministerial Resolution No. 985-2025/MINSA, MINSA ordered the publication of the draft Supreme Decree approving the Regulations for Law No. 32357 (Cancer Forgetfulness Law), together with its draft Regulations and explanatory memorandum, in order to receive comments and contributions from the public.
The draft seeks to develop rules so that people who have overcome cancer can contract health services or insurance without being treated differently because of their cancer history, establishing criteria for application and obligations for actors in the system, including IAFAS, insurers, IPRESS, and entities that offer health services and insurance in the field of oncology.
NATIONAL ONCOLOGY NETWORK: MINSA APPROVES NEW TECHNICAL STANDARD FOR ITS MANAGEMENT
Through Ministerial Resolution No. 073-2026/MINSA, MINSA approved NTS No. 241-MINSA/DGIESP-2026 “Technical Health Standard for the Management of the National Oncology Network,” with the purpose of organizing and strengthening the coordination of providers that offer oncology care at the national level. The standard is part of the National Cancer Law and the regulatory definition of the National Oncology Network as a coordinated group of public, private, or mixed IPRESS that provide comprehensive cancer diagnosis and care services.
The NTS establishes provisions to improve access to comprehensive cancer care, promoting a continuous care pathway from suspicion or positive screening to diagnosis, treatment, rehabilitation, follow-up, and palliative care, with referral and counter-referral support within the Network. It also defines roles and responsibilities in the governance and operation of the Network, including INEN as the lead agency, regional authorities, and member institutions, and establishes guidelines for standardized information management using a digital tool with interoperability and personal data protection criteria.
Finally, it includes relevant operational annexes, including a list of Level II and III healthcare facilities that make up the Network, the associated benefits scheme, and a set of indicators for monitoring and evaluating performance, focused on timely diagnosis and treatment initiation, among other factors.
OVERVIEW OF MEDICAL CANNABIS
Our Life Sciences team published a newsroom article that compiles and summarizes key information on medical cannabis in Peru.
Based on public information available to administrative authorities as of December 2025, it presents an overview of medical cannabis authorizations in Peru, reflecting a growing regulated market with a focus on traceability and health control. Among the consolidated indicators, there are more than 60,000 registered patients, more than 90 commercial establishments, and more than 35 health registrations, suggesting an ecosystem with greater formal supply and demand under supervision.
In terms of authorizations, there is one license for production with cultivation, one license for the production of derivatives, and one license for artisanal production with associated cultivation, in addition to two licenses for preclinical studies of products for human use and one license for agricultural scientific research with cultivation, which shows movement in both production capacities and scientific support activities.
EVOLUTION OF THE REGULATORY FRAMEWORK FOR THE TREATMENT OF RARE OR ORPHAN DISEASES (ERH)
In a recent newsroom article, our Life Sciences team chronologically systematizes the main milestones of the Peruvian regime applicable to ERH, from the enactment of Law No. 29698 (2011) and the issuance of the first official lists in 2014, to the consolidation of institutionality and guidelines through the creation of a specialized directorate and the approval of regulations aimed at comprehensive care.
The compilation also highlights the 2019-2024 cycle, marked by updates to listings, the adoption of a National ERH Plan 2021-2024, and the incorporation of measures to regulate the financing and evaluation of high-cost health technologies, in line with an agenda of progressive strengthening of the system.
Finally, recent changes aimed at modernizing and accelerating regulatory access are identified, including the simplification of health registration for ERH and the implementation of a fast-track mechanism with reduced deadlines and more expeditious processing rules, as well as the creation of instances for the formulation of a new specific plan.