Life Sciences Newsletter - February 2026

Se amplían los plazos

Through Ministerial Resolution No. 148-2026/MINSA, published on February 21, 2026, new deadlines are established for the submission of evidence demonstrating interchangeability (therapeutic equivalence). This includes extending the deadline to deliver the bioequivalence study report (in vivo) provided for in M.R. No. 195-2022/MINSA and setting a deadline to submit the final report of the in vitro therapeutic equivalence study for the update of the sanitary registration.

As a justification, the authority mentions practical limitations such as the shortage of reference drugs, import difficulties, limited capacity of accredited centers/laboratories, and operational restrictions of Contract Research Organizations (CROs), seeking to avoid the risk of shortages while maintaining quality and efficacy requirements.

MINSA aprueba nuevo protocolo para monitoreo de la detección temprana

Through Ministerial Resolution No. 109-2026/MINSA, published on February 5, 2026, the Administrative Directive No. 385-MINSA/DGIESP-2026 was approved, titled "Administrative Directive for monitoring the performance of health professionals in the early detection of cancer."

The directive establishes guidelines to evaluate and follow up on the performance of health personnel in early case identification activities, aiming to strengthen the timeliness and quality of diagnosis nationwide.

Intensive Care Health Service Producing Unit (UPSS Intensive Care)

Through Ministerial Resolution No. 115-2026/MINSA, published on February 11, 2026, the NTS No. 244-MINSA/DGAIN-2026 was approved, titled "Health Technical Standard for the Intensive Care Health Service Producing Unit - UPSS Intensive Care." Subsequently, said standard was amended by Ministerial Resolution No. 159-2026/MINSA.

The technical standard establishes the technical criteria for the organization and operation of the Intensive Care UPSS in health establishments, with the aim of strengthening the quality, safety, and timeliness of care for critically ill patients nationwide.

GMP Certification in India and China

Through Ministerial Resolutions No. 133, 134, 135, 136, 137, 138, 139, 140, 141 y 142-2026/MINSA travel authorizations were granted to Digemid professionals to conduct inspections of pharmaceutical laboratories in India and China. These inspections aim to grant Good Manufacturing Practices (GMP) certification.

FDA publishes guidance

The FDA published the Guidance Document “Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions”, through which it establishes recommendations for manufacturers to prove cybersecurity as a component of safety and efficacy in medical devices that incorporate software or connectivity. The guidance emphasizes the need to integrate risk management and technical evidence in premarket submissions.

The document is aimed at devices with cybersecurity considerations and seeks to reduce clinical risks arising from incidents such as service interruptions, tampering with functionalities, or exposure of sensitive information, promoting a security approach throughout the product's entire life cycle.

Furthermore, it reinforces a regulatory trend that, although not expressly developed in DIGEMID regulations, may operate as a technical reference in pre- or post-market evaluations for holders who manage devices with digital components.