eCTD Adoption Among Major Reforms Underway in China Pharmaceutical Market
Jan21

eCTD Adoption Among Major Reforms Underway in China Pharmaceutical Market

If history is any indication, the China Food and Drug Administration’s (CFDA) adoption of eCTD will also outpace anything previously seen at other regional health agencies. Moving to eCTD submissions is just one of many initiatives currently underway in China as part of an effort to reform regulation of the pharmaceutical industry.

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Globalization of Drug Supply Carries Risks
Jun15

Globalization of Drug Supply Carries Risks

The amount of pharmaceuticals traded increases every year. In the US, imports comprise 40% of the drugs consumed and 80% of the ingredients needed to manufacture drugs. While such trade bolsters the economies of many countries and lowers the price of medicines by creating competition, real risks have affected the supply chain.

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Globalization, Resource Constraints Top List of Regulatory Operations Concerns

On March 10th, I attended the eCTD 2010 conference in Philadelphia. The conference speakers included a number of experienced directors and senior directors of regulatory affairs/reg operations from medium and large Pharma companies. During a panel discussion, an excellent question was posed: What are your biggest challenges – what keeps you up at night? Although we received four different answers from the panelists, they all had a...

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