Tag Archives: regulatory affairs

Brazil: ANVISA bans Lorcaserin (Belviq)

Posted on November 6, 2013 by Maria I. Guaia

Today ANVISA, the Brazilian health authority with competence on the control of pharmaceutical products and APIs, banned the manufacturing, import, commercialization, manipulation and use of the API Lorcaserin. Lorcaserin is the drug substance of Belviq, an innovative weight-loss product that … Continue reading →

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Mexico: new guidelines for the acceptance of GMP certificates

Posted on October 18, 2013 by Maria I. Guaia

In October 2013, the Mexican health authority released a new document setting the criteria that will be used to accept GMP certificates as valid. This criteria applies to certificates of manufacturing facilities both of finished products and API. Summary of … Continue reading →

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ANMAT launches online platform to report drug adverse reactions

Posted on July 13, 2013 by Maria I. Guaia

On July 10th, 2013, ANMAT implemented a system for electronic submission of reports on adverse reactions to drug products.  The system consists on an online form accessible from the website of the National System of Pharmacovigilance. You can access the online … Continue reading →

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Labeling update Argentina: gluten-free/gluten-containing compulsory claim

Posted on July 5, 2013 by Maria I. Guaia

Last month, after active lobbying by the Argentinian Association of Assistance to Celiacs, (ACELA) ANMAT decided to incorporate in the labeling texts of all drug products, information about their content of gluten. Celiac disease is a condition that damages the … Continue reading →

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