Life Sciences Newsletter - July 2026
Themes
NEW MINSA SINGLE TEXT OF ADMINISTRATIVE PROCEDURES (TUPA)
Through Supreme Decree 011-2026-SA, published on July 21, 2026, the Ministry of Health (MINSA) approved a new Single Text of Administrative Procedures (TUPA), repealing the previous TUPA approved by Supreme Decree 001-2016-SA and its subsequent amendments.
The new TUPA is intended to consolidate and systematize, in a single regulatory instrument, all administrative procedures under MINSA's authority, together with the applicable fees and procedural requirements.
BIOEQUIVALENCE AND THERAPEUTIC EQUIVALENCE
Extension of Deadlines
Through Ministerial Resolution 614-2026-MINSA, published on July 14, 2026, the Ministry of Health amended the deadlines set forth in Article 2 of Ministerial Resolution No. 517-2025/MINSA regarding the submission of the documentation required to demonstrate the interchangeability of pharmaceutical products included in the second list of medicines subject to therapeutic equivalence studies.
The revised deadlines are as follows:
- For medicines subject to in vivo bioequivalence studies, the deadline for submitting the following documentation has been extended by an additional 18 months: (i) the bioequivalence study protocol; (ii) the bioequivalence study report; and (iii) the final in vitro study report where a biowaiver based on dose proportionality is relied upon.
- For medicines subject to in vitro studies or biowaivers based on the Biopharmaceutics Classification System (BCS), the deadline for submitting the final in vitro therapeutic equivalence study report has been extended by an additional 12 months.
- The extended deadlines will be calculated from the expiration of the original deadlines established under Ministerial Resolution No. 517-2025/MINSA.
HEALTH TECHNOLOGY ASSESSMENT (HTA)
Draft Amendments to the Regulations
Through Ministerial Resolution 606-2026/MINSA, published on July 14, 2026, the Ministry of Health ordered the publication of draft amendments to the Regulations implementing the National Cancer Law (Supreme Decree No. 004-2022-SA) and the Rare and Orphan Diseases Law (Supreme Decree No. 002-2025-SA).
The proposed amendments seek to streamline the Health Technology Assessment (HTA) process for high-cost health technologies. The principal proposed changes include the following:
- The current exceptional access regime for oncology patients would be replaced with a specific procedure applicable to high-cost medicines that are not included in the National List of Essential Medicines (PNUME) and that have not yet been subject to a high-cost Health Technology Assessment (HTA).
- A new preliminary prioritization stage for requests for high-cost HTAs would be introduced. This stage would be conducted by the CETS-INS using a methodology that takes into account public health needs and the requirements of healthcare providers (IPRESS).
- The deadline for the National Health Technology Assessment Network (RENETSA) to issue high-cost HTAs would be extended from forty-five (45) to sixty (60) business days, calculated from the prioritization stage.
Additionally, through supplementary provisions, the proposal introduces the following additional rules, which do not amend the aforementioned Regulations:
- The proposal strengthens the coordination between the High-Cost Diseases List (LEAC), the Intangible Solidarity Health Fund (FISSAL), and Budget Program No. 0024, with the aim of expanding funding coverage and facilitating access to health technologies that receive a favorable recommendation.
- The CETS-INS would be authorized to request economic evaluation models from marketing authorization holders in order to adapt or validate them for the Peruvian context and streamline the Health Technology Assessment (HTA) process.
Thee Ministerial Resolution establishes a fifteen (15) calendar-day period for stakeholders to submit comments or observations on the draft proposal.
WORK DISABILITY
Technical Health Standard establishing the Evaluation, Qualification, and Certification of Work Disability due to Non-Occupational Illnesses or Accidents
Through Ministerial Resolution 613-2026/MINSA, published on July 14, 2026, NTS 248-MINSA/DGIESP-2026 was approved, titled "Technical Health Standard establishing the procedure for the Evaluation, Qualification, and Certification of Work Disability due to Non-Occupational Illnesses or Accidents."
The Technical Health Standard (NTS) establishes the procedure for the evaluation, qualification, and certification of work disability due to non-occupational illnesses or accidents, as well as the technical criteria applicable to determine said condition when required for granting a disability pension under the National Pension System and other purposes requiring its accreditation.
Its compliance is mandatory for all Ministry of Health healthcare facilities nationwide, as well as for healthcare facilities under mixed Health Care Provider Entities (EPS) authorized for the evaluation, qualification, and certification of disability resulting from non-occupational illnesses or accidents
ELECTRONIC MEDICAL RECORDS
Amendments to the implementation of the Electronic Medical Records Information System (SIHCE)
Through Ministerial Resolution 647-2026-MINSA, published on July 26, 2026, provisions were established for the implementation of the Ministry of Health's Electronic Medical Records Information System (SIHCE).
The regulation repeals Ministerial Resolution 553-2025/MINSA, eliminating the general mandatory use of the SIHCE and allowing health facilities that have other electronic medical record systems to continue using them.
Likewise, it provides that the implementation of the SIHCE shall be carried out progressively, in accordance with each health facility's technological capabilities, excluding from its application those that, as of the effective date, already use a different electronic medical record system.
BLOOD BANKS
MINSA
Through Ministerial Resolution 591-2026, published on July 2, 2026, Administrative Directive No. 392-MINSA/DIGDOT-2026 was approved.
The directive establishes provisions to regulate and monitor the connection of Blood Bank Information Systems to the National Blood Information System of PRONAHEBAS-HEMORED, among which the following stand out:
- The determination of the modules that must be connected to the national system, encompassing the processes of selection, processing, storage, management, and oversight of the transfusion chain.
- The definition of user profiles, as well as the access levels and restrictions applicable to the information recorded in the system.
The directive applies to all public, private, or mixed Health Care Provider Institutions (IPRESS) that have duly authorized Blood Banks registered in the National Registry of Hemotherapy Centers, Blood Banks, and Blood Product Plants.
Likewise, it establishes that the directors of the IPRESS and the heads of Type I, II, and III Blood Banks are responsible for its implementation, and provides that the IPRESS covered must comply with its provisions within a term of ninety (90) calendar days.
RADIOTHERAPY
Approval of the Technical Health Standard for the Radiotherapy Health Service Production Unit
Through Ministerial Resolution 632-2026/MINSA, published on July 24, 2026, NTS 251-MINSA/DGAIN-2026, "Technical Health Standard for the Radiotherapy Health Service Production Unit," was approved.
The Technical Standard establishes the provisions for the organization, operation, and clinical management of Radiotherapy Health Service Production Units, with the aim of contributing to the improvement of the quality of care provided to patients. Likewise, it regulates the minimum requirements for human resources, infrastructure, equipment, financing, biosafety, and indicators applicable to such units, and standardizes the care processes involved in the provision of radiotherapy services.
Compliance with this standard is mandatory for public, private, and mixed health facilities in the health sector that have a Radiotherapy Health Service Production Unit.
INTENSIVE CARE
New Technical Health Standard approved for Intensive Care Health Service Production Units
Through Ministerial Resolution 631-2026/MINSA, published on July 22, 2026, NTS 250-MINSA/DGAIN-2026, "Technical Health Standard for the Intensive Care Health Service Production Unit (UPSS Intensive Care)," was approved.
The Technical Standard updates the regulatory framework applicable to intensive care units and repeals Ministerial Resolution 115-2026/MINSA.
Likewise, it establishes the provisions for the organization, operation, and clinical management of Intensive Care UPSS, as well as the criteria for the comprehensive care of critically ill patients.
Compliance with this standard is mandatory for public, private, and mixed health facilities that have an Intensive Care Health Service Production Unit (UPSS Intensive Care), as well as for the competent health authorities at the national and regional levels.
NON-PROFIT HEALTH ACTIVITIES
Update to the regulatory framework applicable to foreign institutions
Through Ministerial Resolution 611-2026/MINSA, published on July 14, 2026, Administrative Directive No. 393-MINSA/OGTI-2026, "Administrative Directive for the Conduct of Non-Profit Health Activities by Foreign Institutions," was approved.
The regulation updates the framework applicable to these activities and repeals Ministerial Resolution 1182-2003-SA/DM.
Its purpose is to establish the provisions for the promotion, management, and implementation of non-profit health activities carried out by foreign institutions within the scope of the Ministry of Health's authority.
ANDEAN QUALITY SYSTEM
DECISION 965
Through Andean Community Decision 965, published on May 27, 2026, Decision 850, concerning the Andean Quality System, was amended.
The decision updates the regulatory framework applicable to the Andean Quality System and incorporates new provisions aimed at strengthening conformity assessment mechanisms, repealing Decision 506.
Likewise, it establishes measures to harmonize technical criteria, facilitate the exchange of information among competent bodies, and promote the mutual recognition of certificates and test reports.
Among its main scope of application, the decision:
- Implements the Andean Conformity Assessment Services Search Engine.
- Harmonizes the requirements applicable to evaluators and technical experts.
- Updates the rules for the recognition and acceptance of certificates, test reports, and other assessment results.
- Incorporates the international multilateral recognition agreements entered into with ILAC, IAF, IAAC, and Global Accreditation Cooperation Incorporated.
GMP
GMP CERTIFICATION OF FOREIGN PHARMACEUTICAL LABORATORIES
Through Ministerial Resolutions 637, 648, 649, 650, 651 and 654-2026/MINSA, trips by Digemid professionals were authorized for them to carry out inspections of laboratories in India, China, and Bangladesh for purposes of granting GMP certification.