EMA – ICH opens public consultation for international harmonization of real-world evidence terminology

The European Medicines Agency has published for public consultation an ICH Reflection Paper on [...]

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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 [...]

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Nitrosamine Medicinal Products Contamination – Scenario in Europe, United States, and Latin America – updated on July 19, 2023

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

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