CSC's Proposals to Drug Laws
CSC has been engaged in API import and export trade for nearly 20 years, and has become the industry pioneer and weathervane of API trade. In view of current complicated situation of the global pharmaceutical industry and constant adjustment of drug policies and regulations, with rich industry knowledge and unique insights, on December 18th, 2018, and just before NMPA publishes the Revised Drug Laws, CSC published a 168-page book, named < Recommendations of Drug Law -- the API and Its related >, and the book was delivered to the relevant departments and department heads. CSC mainly raised 13 articles in the book, such as how to standardize and improve GMP inspection, DMF submission, APIs' independent review and approval, import filing, and how to minimize APIs' monopoly. All 13 articles have been expressed with full elaboration and illustration.
On April 4th, 2019, in the revision draft for comments of Drug Law published by NMPA, seven of CSC's 13 proposals were completely adopted, and two were adopted partially. The revised Drug Law (including CSC's Proposals) was finally published by NMPA on July 16th, 2019.
In future, CSC will also hold more responsible attitude towards the pharmaceutical trade and supervision by putting forward more constructive proposals and opinions, we firmly believe that this is not only beneficial to China's pharmaceutical industry by creating a more healthy medical environment, make benefits to masses of Chinese medicine practitioners and medical patients, will also play a very active role on the development of international pharmaceutical industry.
Details of No. 56 order of 2019 by NMPA, please refer to "Industry News" on CSC's website through www.csc.cn.