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ANVISA – Proposal for new Bioavailability/ Bioequivalence (BA/BE) Studies

On January 2, 2020 ANVISA published in the Brazil the Public Consultation Nº 760 which provides on

The European Medicines Agency (EMA) and its European and international partners launched a pilot pro

With two publications on December 16, Infarmed informs the public about measures taken in support of

The International Harmonization Council (ICH) met in Singapore from 16 to 20 November 2019, bringing

On August 26, 2019, the Standing Committee of the National People’s Congress of China passed the A

In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in several bloo

After ten years of extensive debate, since the enactment of Law 11.903 / 2009, on November 13th, RDC

On November 7, 2019, ANVISA published the Resolution RDC 318/2019, which defines the criteria for co

The Mexican Foreign Trade Receipt System (VUCEM) is an integral service platform that facilitates ac

A marketing authorization submission represents a major effort for the pharmaceutical industry, and

Latin America is increasingly raising interest from pharmaceutical companies in other regions. It is

Approved by Anvisa’s Board of Directors, the Public Consultations of the New Regulatory Framew