Recently, the National Medical Products Administration is soliciting opinions on the regulations for the implementation of the drug administration law of the People's Republic of China (Revised Draft for comments). In order to promote the construction of ecological civilization and green development, meanwhile to give full scope to the functions of think tanks and build a world-class academic society, the Scientific Ethics Working Group of China Biodiversity Conservation and Green Development Foundation (CBCGDF) actively responded to the call and put forward the following suggestions after careful study:

（1） We suggest to add in Article 9 [encouraging innovation]: To promote science and technology for good and abide by science and technology ethics" as part of the national drug innovation system. At present, China's scientific and technological innovation is developing rapidly, and the challenges of scientific and technological ethics are increasing day by day. However, there are still some problems in the governance over ethics in science and technology, such as imperfect system and mechanism, unbalanced development of fields. It has been difficult to adapt to the practical needs of scientific and technological innovation and development. The pharmaceutical innovation system is no exception. This suggestion is based on the opinions on the “Guidelines to strengthen the governance over ethics in science and technology” issued by the General Office of the CPC Central Committee and the General Office of the State Council.

（2）We suggest to add in Article 45 [drug traceability obligations]: traceability of raw materials. In the revised draft, the information-based traceability system has not yet been mentioned. In order to implement the requirements of "strictly restrict the use of wild animals in medicine, and those involving endangered wild animals and plants shall comply with relevant national regulations" in Article 32 [protection and utilization of medicinal materials resources] of the revised draft, the information of raw materials shall be included as part of the drug traceability system in Article 45[Drug Traceability Obligation].

（3） In the revised draft, there is no mention of the ethics of laboratory animals. In order to implement the requirements of "strengthening the review and supervision over ethics in science and technology " and "respecting the right to life" in the “Guidelines to strengthen the governance over ethics in science and technology”, we suggest that the following statement should be included: to ensure that when the use of laboratory animals is involved in drug innovation, it should meet the requirements of "reduction, replacement optimization the use of laboratory animals ".

[Note] This article is the 22nd in the series of prospective research over ethical issues in scientific and technological innovation. This series is launched by the International Scientific Ethics Working Group of China Biodiversity Conservation and Green Development Foundation. It includes case study and cutting-edge information on major, frontier, emerging and typical issues of international science and technology ethics. Ethics go first before scientific and technological innovation. The purpose of “prospective study on the ethical issues of scientific and technological innovation” is to help the Chinese scientific community to deeply participate in global scientific and technological governance, to build a world-class academic society, to help scientific and technological community to effectively prevent and control scientific and technological ethical risks, and to continuously promote science and technology for good meanwhile benefiting mankind and jointly building a shared future for all life on earth.

Original Chinese Article:

https://mbd.baidu.com/newspage/data/landingsuper?sShare=1&context=%7B%22nid%22%3A%22news_8998127454655339119%22,%22sourceFrom%22%3A%22bjh%22%7D

Translator: Sara

Editor: Lucy     

Contact: v10@cbcgdf.org; +8617319454776

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