International experience and Chinese exploration of regulatory model of gene therapy drugs
As a new therapeutic modality,gene therapy drugs(GTDs)play a therapeutic role and also have many risks,which brings challenges to the regulation of GTDs.The United States(US)and the European Union(EU)have established a relatively perfect system in terms of the regulatory body,regulatory basis and listing regulation,which is worthy of China's reference.China's regulation of GTDs still exists in the regulatory basis level is not detailed,the regulatory content is not mature and transparent,the main body of the regulatory implementation and the body of the responsibility is not clear enough and other issues.It is suggested that our country can learn from the advanced experience of the US and the EU,divide and control the risk of GTDs,set up an expert technical team,establish an advisory committee,and strengthen international communication and exchange,so as to improve the regulatory system of GTDs and enhance the safety of such drugs in China.
genetic therapyregulationrare diseasebiological productsinvestigational new drug application
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