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Regulations and guidelines should be strengthened urgently for re-evaluation on post-marketing medicines in China
- Chinese Journal of Integrative Medicine Vol. 19, Issue 7, Pages: 483-487(2013)
- Affiliations：
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences,Beijing,China
- Author bio：
- Funds：Supported by the Research on Key Techniques of Reevaluation of Post-marketing Chinese Medicines, the Ministry of Science and Technology (No. 2009ZX09502-030) and the Sixth-Science Foundation of Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences (No. Z0215)
DOI：10.1007/s11655-013-1500-0
CLC：Published：2013，
Published Online：2 July 2013，
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Xie, Ym., Tian, F. Regulations and guidelines should be strengthened urgently for re-evaluation on post-marketing medicines in China., Chin. J. Integr. Med. 19, 483–487 (2013). https://doi.org/10.1007/s11655-013-1500-0
Yan-ming Xie, Feng Tian. Regulations and guidelines should be strengthened urgently for re-evaluation on post-marketing medicines in China. [J]. Chinese Journal of Integrative Medicine 19(7):483-487(2013)
Xie, Ym., Tian, F. Regulations and guidelines should be strengthened urgently for re-evaluation on post-marketing medicines in China., Chin. J. Integr. Med. 19, 483–487 (2013). https://doi.org/10.1007/s11655-013-1500-0 DOI：
Yan-ming Xie, Feng Tian. Regulations and guidelines should be strengthened urgently for re-evaluation on post-marketing medicines in China. [J]. Chinese Journal of Integrative Medicine 19(7):483-487(2013) DOI： 10.1007/s11655-013-1500-0.
摘要
This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on postmarketing surveillance (also named pharmacovigilance)
therefore
their regulation systems are nearly perfect. In China
the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects
even lack in some important aspects
and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines
by learning from the ideas of foreign advanced regulations
then fully integrating them with China’s actual conditions
and cooperating with multidisciplinary researchers.
Abstract
This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on postmarketing surveillance (also named pharmacovigilance)
therefore
their regulation systems are nearly perfect. In China
the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects
even lack in some important aspects
and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines
by learning from the ideas of foreign advanced regulations
then fully integrating them with China’s actual conditions
and cooperating with multidisciplinary researchers.
关键词
post-marketing medicinesre-evaluationregulations and guidelinespharmacovigilance
Keywords
post-marketing medicinesre-evaluationregulations and guidelinespharmacovigilance
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