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CDER Seeks Manufacturers for Quality Benchmark Study

The Center for Drug Research and Evaluation (CDER) is inviting drugmakers to take part in a study of pharmaceutical quality management systems.



The agency aims to find the attributes of effective quality systems for use in developing a quality benchmark.



The study is being conducted by Dun & Bradstreet and the University of St. Gallen in Switzerland. It will begin this month and end in December. 



[FDANews]

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COVID-19 to setback blockchain implementation in global pharmaceutical supply chains

Even though blockchain stands out as a potential solution to improve pharmaceutical supply chains, COVID-19 may become a hindrance rather than a trigger in the technology’s future implementation...

05

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Eight Global Pharmaceutical Companies Show Interest in India’s API Expansion Plan

India’s plan to draw foreign majors to ramp up production of active pharmaceutical ingredients (APIs) has drawn interest from eight companies as it mulls extending sops to existing domestic entities...

28

Mag

EMA explains GMP and GDP flexibilities amid COVID-19

The European Medicines Agency (EMA) and its counterparts at the European Commission and Heads of Medicines Agencies have updated their questions and answers guidance on regulatory expectations for medicinal...

27

Mag

No Near-Term Impact on Chinese API Makers as Pharma Supply-Chain Shifts

Chinese active pharmaceutical ingredient (API) makers are unlikely to be significantly affected in the medium term by increasing trade protectionism and customer moves to reduce dependence on supplies...

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