COFEPRIS – Recognition of Marketing Authorizations from Reference Authorities – updated 18th March

On January 28, 2020, an Agreement from the Mexican Comisión Federal para la Protección Contra Ries

Ler mais

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

Ler mais

EMA – Pilot programme for international cooperation in GMP inspection of manufacturers of sterile medicinal products for human use

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

Ler mais

INFARMED – Economic Evaluation by INFARMED

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

Ler mais

ICH News

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

Ler mais

Update in Drug Regulation in China – Revocation of GMPc Requirements

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

Ler mais

Nitrosamine Medicinal Products Contamination – Scenario in Europe, United States, and Latin America – updated on August 8, 2022

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

Ler mais

ANVISA – Traceability/Serialization

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

Ler mais

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

Ler mais

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

Ler mais

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

Ler mais

Latin America – Regulatory Agencies

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

Ler mais