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 […]
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. Ana Susana Rojas Avalos Regulatory Intelligence Consultant SCR Consulting Peru The Sanitary Registration is a legal instrument granted by the Ministry of Health, which, according to Law No. 29459 “Law of Pharmaceutical Products, Medical Devices and Health Products” and Supreme Decree N° 016-2011 “Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, […]
Perú: Estos son los documentos requeridos para importar los siguientes productos: Medicamentos – Registro Sanitario o Certificado de Inscripción y Ficha Resumen (VUCE) – Certificado de Análisis (lote) – Certificado de BPM o equivalente – Certificado Oficial de Importación (COI) y Autorización RD para Ingreso (Para psicotrópicos y narcóticos) Biológicos y derivados de plasma humano – Salud […]
Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist & Regulatory Affairs Coordinator SCR Consulting Bolivia The safety and efficacy of pharmaceutical products are influenced not only by their intrinsic properties, but also by their stability during the manufacturing process. Based on these premises, manufacturers and the Bolivian Drug Regulation Authority must work together to ensure that […]
Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist & Regulatory Affairs Coordinator SCR Consulting Bolivia The safety and efficacy of medicines are influenced not only by their intrinsic properties, but also by their stability during the manufacturing process. Based on these premises, manufacturers and the Bolivian Medicines Regulatory Authority must work together to ensure that all […]