On June 24, 2025, the Commission of the Andean Community (CAN) approved Decision No. 944, a key amendment to Decision 833, aimed at updating and optimizing the regional regulatory framework for cosmetic products. This decision strengthens legislative harmonization among CAN member countries (Bolivia, Colombia, Ecuador, and Peru) by incorporating technological advances, modern regulatory practices, and […]
Prepared by Carolina Núñez – Associate Consultant in Quality Assurance and Regulatory Intelligence On Friday, June 13, 2025, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) convened stakeholders from the pharmaceutical sector to present the scope of Supreme Decree No. 008-2025-SA, which modifies key articles of the Regulation of Pharmaceutical Establishments (Supreme Decree No. […]
Regulation of Medicines by the European Medicines Agency (EMA) The European Medicines Agency (EMA) is the regulatory body of the European Union responsible for the scientific evaluation and supervision of medicines developed for commercialization in the European market. Its operations are governed by Directive 2001/83/EC and Regulation 726/2004, which establish the requirements and procedures for […]
Regulatory Reliance in Chile: A Step Forward in the Evaluation of Biological Medicines The Institute of Public Health of Chile (ISP) has implemented a regulatory reliance mechanism for granting health registrations for biological pharmaceutical products. This procedure, formalized through Exempt Resolution No. E679/25 on January 27, 2025, allows the National Medicines Agency (ANAMED) to use […]
Q.F. Milagros Consuelo Arista Arévalo QA Specialist & Pharmacovigilance and Technovigilance Coordinator SCR Consulting Peru The outsourcing of pharmacovigilance services is an increasingly utilized strategy by pharmaceutical companies to optimize resources and ensure regulatory compliance. However, this practice must be conducted under strict quality standards and established regulations. The Good Pharmacovigilance Practices Manual (Ministerial Resolution […]
Q.F. Milagros Consuelo Arista Arévalo QA Specialist & Pharmacovigilance and Technovigilance Coordinator SCR Consulting Peru Pharmacovigilance is a fundamental pillar in drug safety, ensuring that the benefits of medications outweigh any potential risks. In this context, artificial intelligence (AI) emerges as a key tool transforming this field, enabling earlier detection of adverse effects, more efficient […]
Q.F. Milagros Consuelo Arista Arévalo Quality and Regulatory Affairs Specialist SCR Consulting Peru With the purpose of establishing the technical and sanitary conditions for the operation of Pharmaceutical Establishments, on July 2011, the “Regulation of Pharmaceutical Establishments” was published in the Official Newspaper El Peruano, approved through Supreme Decree No. 014-2011-SA. In this document, for […]
Q.F. Ronald Erik Quiñonez Dextre Regulatory Affairs and Pharmacovigilance Analyst SCR Consulting Peru As part of the development of the pharmacovigilance system in Peru, since the publication of the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Sanitary Products (Supreme Decree No. 016-2011-SA), the preparation and presentation of the […]
Autora: Q.F. Ana Susana Rojas Avalos El Producto Dietético es aquel producto cuyo propósito es complementar la dieta normal, consistiendo en fuentes concentradas de nutrientes u otras sustancias que tienen un efecto nutricional o fisiológico, en forma simple o combinada y dosificada. Además, solo se utilizan para el consumo oral, según la definición [...]
Jeanette Cornelio Bello RESUMEN Los productos cosméticos en Perú están regulados por una normativa andina, conocida como Decisión. Este artículo expone de manera muy concisa los inicios de la regulación de productos cosméticos en la Subregión Andina para comprender la nueva decisión, la Decisión 883, que está en vigor desde [...]