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China-Denmark Drug Regulatory Thematic Seminar held in Beijing
2018-04-19

On the morning of April 13, 2018, the China-Denmark Drug Regulatory Thematic Seminar was held in Beijing. The Danish Minister of Health Ellen Trane Nørby and the Director General of the Department of International Cooperation of the former CFDA attended the seminar and delivered speeches. Anders Carsten Damsgaard, Danish Ambassador to China, Thomas Senderovitz, Director General of the Danish Medicines Agency and the experts from Center for Drug Evaluation of the former CFDA, etc., participated in the seminar.

Thomas Senderovitz introduced the main responsibilities of the Danish Medicines Agency, the cooperation with the Chinese drug regulatory agency, and the Danish drug regulatory policies, such as drug quality control and timely supply.

The expert on drug review from Center for Drug Evaluation of the former CFDA introduced the guiding principles for drug registration applications in China, and illustrated in details the regulatory requirements on clinical trial application in China, new drug application, renewal and post-approval regulations, requirements on ethical committee approval before clinical trial application submission and considerations of dossier requirements of excipients and packaging materials. Representatives from Danish pharmaceutical industry also participated in the seminar.


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