On April 20, 2026, Peru issued Decree 31/2026, a regulatory update modifying key provisions of Law No. 29459 on pharmaceutical products, medical devices, and sanitary products for human use. The decree, published in the official gazette El Peruano, introduces specific changes to articles 31 and sections 57 through 69 of the law, particularly addressing requirements for good manufacturing practices and product registration procedures.
The modification adds a new fourth paragraph to article 31, which clarifies exemptions related to the submission of Good Manufacturing Practice (GMP) certificates for certain pharmaceutical products. According to verified provisions of Law No. 29459, products prequalified by the World Health Organization (WHO) are exempt from presenting GMP certificates under specific conditions outlined in articles 11 and 15 of the law. This exemption aims to streamline access to internationally vetted medicines while maintaining safety standards through WHO’s prequalification program.
Decree 31/2026 further revises articles 57 to 69, which govern the registration, importation, and post-market surveillance of pharmaceutical and sanitary products. These changes reflect ongoing efforts by Peru’s National Authority of Pharmaceutical Products, Medical Devices, and Sanitary Products (ANM) to align national regulations with international benchmarks, particularly those set by the Pan American Health Organization (PAHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The decree was signed by the President of the Council of Ministers and countersigned by the Minister of Health, following standard procedural requirements for executive decrees under Peru’s administrative law framework. It entered into force the day after its publication in El Peruano, as stipulated by Article 57 of Peru’s General Administrative Procedure Law (Law No. 27444).
Stakeholders in the pharmaceutical sector, including domestic manufacturers and importers, are required to review their compliance protocols to ensure alignment with the updated provisions. The ANM has indicated that guidance documents detailing implementation procedures will be issued within 30 business days of the decree’s publication, consistent with its regulatory communication practices.
Law No. 29459, originally enacted in 2009, serves as the foundational legal framework for regulating products that impact human health in Peru. It establishes core principles related to safety, efficacy, and quality, and defines the responsibilities of various actors across the product lifecycle—from research and development to distribution and patient use. The law likewise created the ANM as the decentralized public entity responsible for oversight, evaluation, and authorization of pharmaceutical and sanitary products.
The WHO prequalification program, referenced in the decree, evaluates vaccines, medicines, and diagnostic tools for quality, safety, and efficacy to support procurement decisions by United Nations agencies and low- and middle-income countries. Products receiving WHO prequalification undergo rigorous assessment, including dossier review, facility inspections, and consistency batch testing, which justifies their exemption from duplicate national GMP certification requirements under certain conditions.
Peru’s regulatory adjustments come amid broader regional initiatives to strengthen health product regulation across Latin America. The Pan American Network for Drug Regulatory Harmonization (PANDRH) has encouraged member states to adopt reliance mechanisms that recognize authoritative approvals from stringent regulatory agencies and WHO, thereby reducing duplication and accelerating access to essential medicines.
Legal experts note that while decrees like 31/2026 allow for timely technical adjustments to existing laws, they must remain within the bounds of the original legislation and cannot introduce substantive changes that require congressional approval. Any modification altering fundamental rights, obligations, or the law’s core objectives would necessitate a formal legislative process.
The ANM has committed to maintaining transparency in the implementation of Decree 31/2026, including publishing updates on its official website and hosting virtual workshops for healthcare professionals, industry representatives, and regulatory stakeholders. Interested parties can access the full text of the decree and Law No. 29459 through the ANM’s digital repository and the official gazette portal.
As Peru continues to refine its regulatory architecture for health products, observers emphasize the importance of balancing regulatory efficiency with robust oversight. Ensuring that exemptions and reliance mechanisms do not compromise product safety remains a central focus for regulators, healthcare providers, and patient advocacy groups alike.
For the latest official updates on Decree 31/2026 and related regulatory developments, readers are encouraged to consult the ANM’s website and the Peruvian Ministry of Health’s regulatory news section, both of which provide timely access to gazette publications, guidelines, and stakeholder advisories.
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