Reflection on Drug Regulatory Globalization Trend from the Heparin Sodium Event

Abstract

Abstract: Objective To provide some suggestions to cope with the challenges of drug regulatory globalization. Methods The investigation to the reason of event inspection, communication, rehabilitation and the deep risk of supply chain were analyzed through reviewing measures that FDA and relevant parties had given to heparin sodium event. Results Drug regulatory globalization is essentially the globalization of raw materials, intermediate products and preparations supply chain. Conclusion FDA’s global drug regulation has provided referential experience to China, and China should comply with the trend of regulatory globalization and take active countermeasures to ensure the safety of the drug supply chain.

Key words: heparin sodium event, drug regulatory globalization , supply chain

CLC Number:

R951

TIAN De-long, HUANG Zhi-lu. Reflection on Drug Regulatory Globalization Trend from the Heparin Sodium Event [J]. Chinese Journal of Pharmacovigilance, 2016, 13(1): 42-46.

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https://zgywjj.magtechjournal.com/EN/Y2016/V13/I1/42

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