For the generic drugs that are manufactured in China and approved by the EU, USA, or Japan which have already been launched in the Chinese market and plan to produce on the same product line and prescription process, the manufacturers must fill in and submit the supplementary application of the drugs, and specifically state either “application of consistency evaluation in collinear production, with the changes on the production line or prescription process” or “application of consistency evaluation in collinear production, without changes on the production line and prescription process”.

China has recently published several policies regarding medicine reform, and major measures being implemented within in the first three quarters of 2018 include: “Technical Guideline on Receiving Overseas Clinical Testing Data” issued by NMPA, for speeding up connection between domestic drug market and international market; “Notice on Soliciting the List of Urgently Needed New Overseas Clinical Drug” issued by Center for Drug Evaluation, NMPA, for accelerating the approval process of imported overseas drugs with excellent efficacy and urgently needed drugs for Chinese market; “Generic Drug Procurement with Quantity Demand” is another important policy which is issued by National Healthcare Security Administration. These new policies are implemented to ensure and improve the quality and efficacy of drugs, encourage innovation, lower drug prices and reform the supply-side structure.

In the first three quarters of 2018, the output of anti-infective drugs dropped by 11.53% YoY, suffering more decrease compared with 2% drop YoY recorded in the same period of 2017. This output decline was mainly caused by output reduction of benzylpenicillin sodium by 680 tons, amoxicillin by 1060 tons and neomycin by 1172 tons. Production of above-mention drugs were cut by CSPC Pharma, Inner Mongolian Changsheng Pharmaceuticals and Yichang Sanxia Pharmaceutical, among others. In the first three quarters of 2018, the export supply of anti-infective drugs increased by 1% YoY, compared with 24.8% drop YoY recorded in the same period of 2017. Drugs with large export volume include amoxicillin, neomycin, trimethoprim, ceftriaxone sodium, oxytetracycline and procaine penicillin, etc.