Life Sciences Newsletter - March 2026
Themes
Digital Health Technologies
MINSA approves the Installed Capacity Registry
Through Ministerial Resolution No. 170-2026/MINSA, published on March 3, 2026, Administrative Directive No. 387-MINSA/OGTI-2026 was approved, entitled “Directive establishing the Registry of Installed Capacity in Digital Health Technologies.”
The directive establishes a national framework for reporting and technological standardization applicable to public-sector IPRESS, aiming to serve as a technical reference for providers such as healthcare software developers, telemedicine platforms, medical devices with digital components, and artificial intelligence-based solutions.
It also incorporates cybersecurity guidelines related to access management, the use of secure protocols, backup mechanisms, and data center infrastructure, which may require adjustments to ensure compatibility with the standards being consolidated by MINSA.
Draft Regulation of the Law
Tobacco, nicotine and substitutes
Through Ministerial Resolution No. 236-2026/MINSA, published on March 20, 2026, the publication of the draft Regulation of Law No. 32159 was ordered, which regulates the control of the consumption of tobacco, nicotine, or substitute products.
The draft establishes restrictions and prohibitions applicable to advertising, commercialization, and consumption, and incorporates measures for surveillance, enforcement, information, and education aimed at preventing health, social, environmental, and economic impacts.
The Ministry of Health (MINSA) will receive suggestions, comments, or recommendations from public or private entities, as well as from the general public, for a period of ninety (90) calendar days, counted from the day following the publication of the draft.
MINSA
National Telehealth Plan 2026
Through Ministerial Resolution No. 293-2026/MINSA, published on March 29, 2026, the “National Telehealth Plan 2026” was approved.
The plan aims to strengthen access to healthcare services through strategies focused on improving service delivery, data coding, and the resolution capacity of healthcare facilities, incorporating digital tools to modernize healthcare provision.
Multisectoral Working Group for the Evaluation of Pharmaceutical Products
Through Ministerial Resolution No. 280-2026/MINSA, published on March 26, 2026, the creation of a temporary Multisectoral Working Group was approved. This group is responsible for evaluating matters related to the supply and availability of pharmaceutical products and medical devices, prioritizing those intended for the treatment of oncological diseases.
The group will have a duration of 90 calendar days from its installation and must submit a final report with findings and recommendations.
Manual for Estimation and Programming of Medicines and Medical Devices
Through Ministerial Resolution No. 193‑2026/MINSA, published on March 12, 2026, the “Manual for the estimation and programming of pharmaceutical products, medical devices, and health products” was approved.
The manual establishes guidelines for executing units of the Ministry and Regional Governments to optimize estimation and programming processes through demand forecasting methods, incorporating evaluation criteria and continuous improvement measures aimed at modernizing these processes.
Electronic Medical Records
Extension of accreditation deadlines
Through Ministerial Resolution No. 188-2026/MINSA, published on March 10, 2026, new deadlines are established for the accreditation of Electronic Clinical Record Information Systems, extending the deadline to implement the provision of healthcare services in electronic document format provided in Ministerial Resolution No. 164-2025/MINSA, by an additional twelve (12) months.
As justification, the authority indicates that healthcare establishments face operational difficulties in fully implementing the electronic clinical record system, arising from limitations in IT equipment and connectivity.
Legislative Proposal
Regulation of radiopharmaceuticals
Through Bill No. 14267/2026-CR, it is proposed to amend Law No. 29459 in order to establish a specific regulatory framework for radiopharmaceuticals.
Among the main proposals, the following are set out:
- Joint regulation between the National Medicines Authority (ANM) and the Peruvian Institute of Nuclear Energy (IPEN) of activities related to research, manufacture, import, export, distribution, preparation, fractioning, dispensing, and commercialization of radiopharmaceuticals.
- Special sanitary registration for industrially produced radiopharmaceuticals, adapted to their short half-life.
- Conditional sanitary registration for radiopharmaceuticals in Phase II or III clinical trials in situations of emergency, shortage, or scientific research.
- Exemption from sanitary registration for radiopharmaceuticals prepared for immediate use from components with a valid registration.
- Manufacture, preparation, and dispensing only in authorized radiopharmacies, under applicable good practices.
- Classification of radiopharmacies into three categories: industrial, centralized, and hospital.
Genetically Modified Organisms (GMOs)
Guidelines
Through Ministerial Resolution No. D000068-2026-MINAM-DM, dated March 6, 2026, the “Guidelines for determining the status of Genetically Modified Organisms (GMOs), within the framework of Law No. 29811, extended by Law No. 31111, applicable to products or organisms developed using new biotechnological tools” were approved. These guidelines develop Article 7 of the Regulation approved by Supreme Decree No. 012-2023-MINAM and are incorporated into the existing prohibition regime in force until December 31, 2035, on the entry and production of GMOs for cultivation or breeding purposes.
The guidelines establish technical and scientific criteria to determine, on a case-by-case basis, when an organism or product obtained through new biotechnological tools does not qualify as a GMO. Likewise, they regulate the minimum technical information that may be voluntarily submitted to MINAM to obtain regulatory clarity regarding GMO status.
REPEC
Analysis of clinical trial research centers
According to the analysis of the Peruvian Clinical Trials Registry (REPEC), conducted by our Life Sciences team, as of February 2026, there are 263 research centers and a cumulative total of 5,088 authorized clinical trials. In accordance with the Clinical Trials Regulation approved by Supreme Decree No. 021-2017-SA, each clinical trial must be conducted in a registered center and comply with the corresponding authorization requirements.
Although the figures show a broad network of authorized institutions, 13.24% of the centers have no registered studies, indicating underutilized installed capacity. Likewise, 4.6% are inactive for new trials, a situation that requires regularization prior to their reinstatement. The two most active centers correspond to oncology-specialized institutions, confirming the significant focus of clinical research on cancer-related diseases.
DIGEMID
- Alert 33: Risk of therapeutic failure associated with the use of polyacrylonitrile (PAN) membranes in patients treated with caspofungin, leading to the updating of warnings and precautions in technical data sheets.
- Alert 36: Market withdrawal of batch No. 2090173 of the medical device Sterile Fractionated Gauze – FAVETEX, after non-conforming results were identified in physical characteristics testing (presence of lint and loose fibers).
GMP Certification
Through Ministerial Resolution No. 177-2026/MINSA the travel of DIGEMID professionals was authorized to conduct inspections of laboratories in India for the purpose of granting Good Manufacturing Practices (GMP) certification.