PNUME: MEDICINES FOR DIABETES TREATMENT
Ministerial Resolution 182-2025/MINSA approved the complementary list of medicines for the treatment of type 2 diabetes mellitus and arterial hypertension to the Single National Formulary of Essential Medicines for the Health Sector.
DIGEMID GRANTS BPM CERTIFICATE
By means of Ministerial Resolutions 135, 136, 142, 142, 143, 149, 152, 152, 173, 194, 197, 198, 199-2025/MINSA, Digemid officials were authorized to travel to Brazil, China, Colombia, India, Mexico, Turkey and Vietnam to carry out inspections to laboratories in order to grant GMP certification.
NEW REGULATION OF LAW 29698
Supreme Decree 002-2025-SA approved the new Regulation of Law 29698, “Law that declares of national interest and preferential attention the treatment of persons suffering from rare or orphan diseases”, in order to adapt the Regulation of Law 29698 to the amendments of Law 31738.
The Regulation regulates the following topics:
It should be noted that, in the third final complementary provision of the Regulation, it is stated that the provisions referring to the sanitary registration of pharmaceutical products for the diagnosis and/or treatment of rare or orphan diseases (ERH) and oncology, mentioned in Article 9 of Law 29698, will be approved by Supreme Decree within sixty (60) calendar days.
ONCOLOGICAL HEALTH TECHNOLOGIES: MULTI-CRITERIA EVALUATION TO GENERATE RECOMMENDATIONS FOR USE
Directorial Resolution 001-2025-CETS/INS approved the methodological guideline N°001-CETS-INS-V.01, “Multicriteria Evaluation Methodological Guideline to generate recommendations for the use of High Cost Oncologic Health Technologies”.
Subsequently, Directorial Resolution 003-2025-CETS/INS established that said methodological guideline will come into effect 90 working days after its publication, that is, on May 26, 2025.
IPRESS MUST ACCREDIT ELECTRONIC MEDICAL RECORDS INFORMATION SYSTEMS
Ministerial Resolution 164-2025-MINSA approved Administrative Directive 373-MINSA/OFTI-2025, “Administrative Directive that establishes the accreditation process for Electronic Health Record Information Systems”.
The purpose of the Directive is to establish the requirements that IPRESSs must meet to accredit their Electronic Health Record Information System (SIHCE) with the ultimate goal of achieving the interoperability of these systems at the national level. This is a key step towards the implementation of the National Electronic Health Record Registry (RENHICE).
The Directive establishes that any IPRESS that has a SIHCE, at any level of development, must initiate the accreditation process within a maximum period of 12 months, counted from the Directive’s entry into force. In addition, IPRESSs that, after 12 months, implement electronic medical records must accredit their SIHCE prior to its implementation.
WORKING GROUP FOR THE REGULATION OF LAW 32195
Life Sciences Newsletter – March 2025 Ministerial Resolution 83-2025-MIDAGRI created a temporary Multisectoral Working Group, under the Ministry of Agrarian Development and Irrigation, to prepare the proposed Regulation of Law 32195, Law for the agricultural development of hemp for industrial use.
