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New Regulation for Stability Studies of Medicinal Products and APIs in Brazil – Resolution RDC 318/2019
On November 7, 2019, ANVISA published the Resolution RDC 318/2019, which defines the criteria for co
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Importation procedures in Mexico – Mexican Foreign Trade Receipt System (Ventanilla Única de Comercio Exterior Mexicano – VUCEM)
The Mexican Foreign Trade Receipt System (VUCEM) is an integral service platform that facilitates ac
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cGMP requirements for Latin American drug products MA submissions – updated 18th May 2021
A marketing authorization submission represents a major effort for the pharmaceutical industry, and
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Latin America – Regulatory Agencies
Latin America is increasingly raising interest from pharmaceutical companies in other regions. It is
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New Brazilian Regulatory Framework for API under Public Consultation
Approved by Anvisa’s Board of Directors, the Public Consultations of the New Regulatory Framew
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EDQM- Published updated list of drafts of monographs for the European Pharmacopoeia
EDQM has published a statement with the updated list of substances which the drafts of its monograph
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