Life Sciences Newsletter - May 2026
Themes
RARE OR ORPHAN DISEASES
Modification of the Regulation of Law No. 29698
Through Supreme Decree No. 006-2026-SA, published on May 13, 2026, the Third Complementary Transitional Provision was incorporated into the Regulation of the Law declaring the treatment of persons suffering from rare or orphan diseases (RODs) to be of national interest and priority care, approved by Supreme Decree No. 002-2025-SA.
This provision was added to the Regulation in order to allow the use of medicines and biological products for the treatment of rare or orphan diseases that are not included in the National List of Essential Medicines (PNUME) or its complementary lists, and whose treatment cost exceeds the high-cost threshold approved by the National Health Authority (ANS), while the decision of the National Network for Health Technology Assessment (RENETSA) on the multi-criteria health technology assessment (MC-HTA) remains pending.
Proposed Expansion of the List
Through Ministerial Resolution No. 478-2026/MINSA, published on May 12, 2026, the publication of the draft List of Rare and Orphan Diseases (RODs) was ordered, under Law No. 29698, which declares the treatment of persons suffering from rare or orphan diseases to be of national interest and priority care.
The draft introduces updates to the current list by incorporating new rare and orphan diseases. It proposes expanding the number of included diagnoses from 546 to 558, using ICD-10 codes.
The Ministerial Resolution establishes a period of fifteen (15) business days for stakeholders to submit comments or observations on the draft.
TOXIC OR HAZARDOUS TOYS AND STATIONERY
Proposed Amendment to the Regulation of Law No. 28376
Through Ministerial Resolution No. 457-2026/MINSA, published on May 8, 2026, the publication of the draft Supreme Decree amending the Regulation of Law No. 28376—Law that prohibits and sanctions the manufacture, importation, distribution, and commercialization of toxic or hazardous toys and stationery—approved by Supreme Decree No. 008-2007-SA, was ordered.
The draft introduces updates applicable to the rules governing the manufacture, importation, distribution, and commercialization of such products, and includes clarifications to definitions and technical safety criteria, with the aim of strengthening health protection.
The Ministerial Resolution establishes a period of ninety (90) calendar days for stakeholders to submit comments or observations on the draft.
SUSALUD
Proposed Amendment to the Infringement and Sanctions Regulation
Through Ministerial Resolution No. 507-2026/MINSA, published on May 27, 2026, the draft Supreme Decree amending the Infringement and Sanctions Regulation of the National Superintendence of Health (SUSALUD), approved by Supreme Decree No. 031-2014-SA, was made public.
The proposal seeks to update SUSALUD’s administrative sanctioning procedure, introducing amendments aimed at improving its speed and efficiency, while strengthening the protection of users’ rights in line with current regulations.
Key changes include adjustments to the rules governing the administrative sanctioning procedure (initiation, pleadings, appeals, and enforcement), as well as the incorporation of new infractions, particularly those related to failure to comply with information requests and the care of pediatric oncology patients.
The Ministerial Resolution establishes a period of fifteen (15) calendar days for stakeholders to submit comments or observations on the draft.
Electronic Notification – SUSALUD: Regulation Approved
Through Supreme Decree No. 009-2026-SA, published on May 29, 2026, the Regulation on mandatory electronic notification via electronic mailbox of the National Superintendence of Health (SUSALUD) was approved.
This regulation establishes the mandatory use of the electronic mailbox as the digital address for the notification of administrative acts and proceedings issued by SUSALUD, within the framework of its supervisory, enforcement, and administrative procedure functions. It further provides that notifications made through the electronic mailbox shall produce legal effects, and that their acknowledgment cannot be contested on the grounds of lack of review.
DIGITAL HEALTH SKILLS
DIGITAL HEALTH COMPETENCIES
Through Ministerial Resolution No. 529-2026/MINSA, published on May 29, 2026, the Technical Document titled “Profile of Essential Digital Competencies for Health Professionals” was approved.
The regulation aims to strengthen the digital competencies of healthcare professionals in order to improve the quality and accessibility of healthcare services for the population, within the framework of the sector’s digital transformation process.
The document sets out the essential digital competencies that health professionals must develop for the proper, safe, and ethical use of digital technologies, including aspects related to health information systems, telehealth, data handling, and information security.