Peru’s cosmetics market is attracting new products and companies. Drawing on COPECOH insights, SCR Consulting explores how portfolio selection, NSO planning, labeling and import readiness can support a well-prepared launch.
When a medical device is not subject to mandatory health registration in Chile, the ISP Background Review may serve as a technical and commercial support tool. Learn when it applies, what its scope is, and how to integrate it into a market-entry strategy.
Exempt Decree No. 25 of 2026 brings 39 categories of medical devices and IVDs under Chile’s mandatory health registration framework. We analyze the products covered, implementation timelines, and regulatory implications for companies operating in LATAM.
A drug biowaiver is a regulatory strategy that allows therapeutic equivalence to be demonstrated without conducting in vivo bioequivalence studies, reducing the time and costs associated with marketing authorization. In countries such as Chile, its application is based on the Biopharmaceutics Classification System (BCS) and specific regulatory criteria that pharmaceutical companies must carefully assess. What […]
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 […]