LIFE SCIENCES NEWSLETTER
Ranitidine and DIGEMID
Through Alert 9-2025, DIGEMID suspended the authorization of health registrations for pharmaceutical products containing ranitidine until the holder of the health registration communicates the following:
- Specifications and analytical technique of the finished product, including the limit test for N-nitrosodimethylamine (NDMA), with its respective acceptance criteria and validation of the analytical technique.
- Stability study report (in climatic zone IVA) obtained from the six (6) months of accelerated and long-term stability studies, with results demonstrating that NDMA values are within the acceptable range throughout the entire shelf life of the pharmaceutical product.
Red Dye 3 and DIGEMID’s Position
In Communication 3-2025, DIGEMID reports the following:
- International Background: The US FDA determined that Red Dye 3 causes cancer in male rats exposed to high doses, although there is no conclusive evidence in humans. Therefore, it has established January 18, 2028, as the deadline for US manufacturers to reformulate their pharmaceutical products.
- Measure adopted by Digemid: Despite the lack of conclusive evidence in humans, DIGEMID requests that health registration holders begin the gradual replacement of Red Dye 3 with safer dyes, with a deadline of January 18, 2028.
MINSA presents its 2025-2030 strategic plan
Through Ministerial Resolution 64-2025-MINSA, the MINSA approved the “Institutional Strategic Plan (PEI) 2025-2030 of the Ministry of Health,” a document that establishes the roadmap for the coming years.
In this plan, the MINSA:
- Presents and substantiates the 7 Institutional Strategic Objectives (OEI) and the 40 Institutional Strategic Actions (AEI).
- Determines the priorities of each OEI and AEI for a clear approach aligned with the needs of the health sector.
- Articulates the OEI and AEI with the “Multiannual Sectoral Strategic Plan 2024-2030 of the Health Sector” and with National Policies to maintain coherence and synergy in their implementation.
- Establishes progress indices to measure annual compliance with the OEI and AEI.
GMP certifications of foreign pharmaceutical plants continue
Ministerial Resolutions 93, 94, 95, 114, and 130-2025/MINSA authorized travel by Digemid officials to conduct inspections of laboratories in Argentina, Brazil, and India for the purpose of granting GMP certification.
Gluten-Free Food Labeling Proposed
Through Ministerial Resolution 112-2025-MINSA, the draft Regulation of Law 31881 was published, seeking to guarantee clear information on gluten-free foods.
Key aspects of the bill:
- Identification symbols: The use of the crossed-out grain of wheat with the designations «gluten-free» or «gluten-free» will be regulated. These symbols must be visible and not interfere with the mandatory information on labels and advertisements for processed foods.
- Authorization and requirements: Digesa is the entity responsible for authorizing the use of these symbols, for both domestic and imported products. The requirements for authorization are:
- Food must come from establishments certified with Good Manufacturing Practices (GMP).
- Laboratory analysis must demonstrate less than 20 mg/kg of gluten.
- Authorization is for an indefinite period, but is subject to Digesa oversight.
- Responsibilities and Sanctions: Manufacturers and importers are responsible for complying with these standards. Failure to comply may result in sanctions from Digesa or Indecopi.
The Ministry of Health (MINSA) will receive comments on the draft until May 22, 2025, via email: webmaster@minsa.gob.pe.
New measures for epidemiological surveillance of COVID-19
Through NTS 224-MINSA/CDC-2025 «Technical Health Standard for Epidemiological Surveillance of Coronavirus Disease (COVID-19), Endemic Phase in Peru» (approved by Ministerial Resolution 78-2925-MINSA), the Ministry of Health (MINSA) established a new framework for epidemiological surveillance of COVID-19.
This Technical Health Standard establishes mandatory rules regarding:
- the identification of cases and outbreaks,
- epidemiological surveillance of hospitalized patients and deaths, and
- the genomic sequencing of COVID-19.
Codex Updates Food Labeling Standard
The updated CXS 1-1985 standard, updated with the latest 2024 revision, has been published on the Codex website https://www.fao.org/fao-who-codexalimentarius/codex-texts/list-standards/en/.
Main modifications:
- Allergen Declaration:
- The list of allergens has been updated, classifying them as mandatory and optional.
- Allergens must be highlighted in the list of ingredients in bold or a different color.
- If they are mentioned outside the list of ingredients, they must be preceded by the word «contains.»
- Expiration Labeling: Definitions that differentiate between «best before» and «use by» dates.
FDA Requirements for the “HEALTHY” Claim
The FDA has updated the definition of the term “Healthy” on food labeling: https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/use-term-healthy-food-labeling
This new regulation, announced on December 19, 2024, establishes that a product may be labeled “healthy” if it contains specific amounts of recommended food groups, such as fruits, vegetables, grains, low-fat dairy, or protein, and meets established limits for saturated fat, sodium, and added sugars.
With this update, foods such as nuts, seeds, salmon, olive oil, and eggs now qualify for the “healthy” label, while products such as enriched white bread, high-sugar yogurts, and sugary cereals would no longer meet the criteria. Manufacturers will be able to begin applying the new criteria starting February 28, 2025, and will have until February 2028 to fully comply with the regulations.
