The perspective of drug approval transfer in China

Source: on May 12, 2015, when talking about the term "technology transfer", I can find that the earliest regulation is the invalid 1999 regulation on new drug protection and technology transfer The technology transfer in the current year is only limited to "new drugs", which means the owner of the new drug certificate (original) transfers the new drug production technology to the manufacturing enterprise And the enterprise accepting the transfer of new drug technology shall not transfer the new drug technology again In principle, the application for technology transfer of new drugs will not be accepted for new drugs with simple change of dosage form; for other types of new drugs, the application for transfer will not be accepted if there are more than three units applying for the production of the new drugs The regulations of that year did not mention the technology transfer of drug production approval documents which had been on the market for many years The release of approval transfer in 2009 started from the notice on printing and distributing regulations on the registration of drug technology transfer For the first time, the notice divides drug technology transfer into new drug technology transfer and drug production technology transfer The approval number of drugs allowed to be transferred must meet one of the following conditions: （1） Holding the new drug certificate or holding the new drug certificate and obtaining the drug approval number, the new drug monitoring period has expired; holding the new drug certificate or holding the new drug certificate and obtaining the drug approval number, there is no monitoring period; only holding the new drug certificate, the preparation that has not yet entered the new drug monitoring period or holding the original new drug certificate and no monitoring period Since the issuance of the new drug certificate, the monitoring period established in accordance with the registration classification of the corresponding preparations in Annex VI of the measures for the administration of drug registration has expired; (2) for the varieties without the new drug certificate, both the transferor and the transferee shall be drug manufacturing enterprises that meet the legal conditions, with one party holding 50% of the other party The above equity or shares, or both parties are subsidiaries of the same drug manufacturer holding more than 50% of the shares; (3) for the varieties that have obtained the import drug registration certificate, the production technology may be transferred from the original applicant for import drug registration to the domestic drug manufacturer This means that the regulations in 2009 require that if you want to obtain the drug production approval of domestic manufacturers that have been on the market for many years, you can only take the road of holding shares Listed companies and state-owned enterprises acted as early as 2009-2012 Due to the change of equity of the original enterprise, the name of the manufacturer also changed For example, on August 18, 2010, Zhitong pharmaceutical holding group completed the acquisition of Baoding Sanjiu Jishi Biological Pharmaceutical Co., Ltd by means of capital increase and share expansion, and changed its name to Hebei Zhitong Biological Pharmaceutical Co., Ltd After the acquisition, Zhitong group holds 51% equity of Zhitong biopharmaceutical Since 2010, the original 120 product approval numbers of "Baoding Sanjiu Jishi Biological Pharmaceutical Co., Ltd." have been changed to "Hebei Zhitong Biological Pharmaceutical Co., Ltd." Chenxin pharmaceutical officially separated from the name of "Lu Kang group" to seek independent listing Since 2011, the relevant product names have successively changed from "Shandong Lu Kang Chenxin Pharmaceutical Co., Ltd." In fact, after 2010, the name change of a large number of drug approval number corresponding manufacturers was mainly caused by the equity reform and merger and acquisition of large state-owned enterprises Since 2010, Sinopharm has taken frequent actions China Pharmaceutical Industry Co., Ltd and Sinopharm Xinjiang Pharmaceutical Co., Ltd have realized the restructuring and reorganization of the original Xinjiang pharmaceutical factory in the form of capital increase and share expansion 263 drug approval number changes brought about by the establishment of Sinopharm Xinjiang Pharmaceutical Co., Ltd After the reorganization on November 2, 2011, the corresponding changed drug approval numbers of Sinopharm holding Xingsha Pharmaceutical (Xiamen) Co., Ltd were respectively from Xiamen Xingsha Pharmaceutical Co., Ltd., Xiamen cod liver oil factory and Xiamen Jianfa Pharmaceutical Co., Ltd., with 214 corresponding approvals Similarly, on June 17, 2010, Jilin Yixin Pharmaceutical Co., Ltd., which is controlled by Sinopharm Holding Co., Ltd., was renamed as Sinopharm Yixin Pharmaceutical Co., Ltd., becoming the anti-tumor specialized platform of Sinopharm holding group, etc China Resources Department is also integrating M & A In 2010, Cr Department received CR double crane, and 82 approval numbers of related drugs were changed In addition, Sanjiu pharmaceutical joined China Resources Group in 2008 In February 2010, "Sanjiu Pharmaceutical Co., Ltd." was officially changed to "China Resources Sanjiu Pharmaceutical Co., Ltd." Since then, the first four words of any manufacturer with the name "Sanjiu" before 2010 must be "China Resources Sanjiu" For example, 116 drug approval numbers of "Sanjiu Huangshi pharmaceutical factory" have been changed to "China Resources Sanjiu (Huangshi) Pharmaceutical Co., Ltd."; "Hunan Sanjiu Nankai Pharmaceutical Co., Ltd." corresponding to 45 drug approval numbers have been changed to“ China Resources Sanjiu (Chenzhou) Pharmaceutical Co., Ltd The drug transfer, which has been on the market for many years, has been further liberalized In October 2013, the notice of the State Food and Drug Administration on matters related to the transfer of drug technology in the process of implementing the newly revised drug production quality management standard, was issued The notice further liberalizes the transfer of drug production approval documents that have been on the market for many years: (1) if the drug production enterprise moves as a whole or moves as a whole after being merged, the drug production technology of the original site drug production enterprise can be transferred to the new site drug production enterprise （2） If one party holds more than 50% of the equity or shares of the other party, or both parties hold more than 50% of the equity or shares of the same enterprise, both parties may transfer the pharmaceutical technology （3） The pharmaceutical production enterprises that give up the whole or part of the pharmaceutical form production and transformation can transfer the production technology of corresponding varieties to the enterprises that have passed the newly revised GMP certification, but the production technology of all varieties of the same pharmaceutical form is only limited to one pharmaceutical production enterprise at a time If the GMP transformation of APIs is abandoned, the technology transfer can be conducted for the corresponding drug varieties, and the new GMP certification can be conducted after the transfer is accepted by the transferee Sterile drug manufacturers such as injection manufacturers shall apply for registration of drug technology transfer before December 31, 2014 and other drug manufacturers shall apply for registration of drug technology transfer according to the above requirements before December 31, 2016 Since 2013, the technology transfer of drug approval number has begun to diversify, and foreign enterprises have begun to do so Listed enterprises and large state-owned enterprises are still in layout, and the transactions of small and medium-sized enterprises are more active than in 2010 Such technology transfer is still in progress due to the change of the name of the plant due to the change of equity, for example, "Beijing Shuanghe Pharmaceutical Co., Ltd." and "Beijing Shuanghe Modern Pharmaceutical Technology Co., Ltd." are renamed as "China Resources Shuanghe Pharmaceutical Co., Ltd." Kangzhe acquired 51% equity of Guangxi Guangming Pharmaceutical Co., Ltd (officially renamed as Guangxi kangzhe Guangming Pharmaceutical Co., Ltd on October 10, 2011) by means of cash capital increase and holding, and the 15 approval documents of Guangxi Guangming Pharmaceutical Co., Ltd were renamed as "Guangxi kangzhe Guangming Pharmaceutical Co., Ltd." Individual infers that in 2013, 15 approval numbers of "Huangshi lishizhen Pharmaceutical Group Wuhan XISU Pharmaceutical Co., Ltd." were transferred to "feisenyuskabi (Wuhan) Pharmaceutical Co., Ltd." as one If the regulations allow the transfer of dosage forms, different dosage forms of one manufacturer will be divided into different manufacturers, such as Guangdong Luoding Pharmaceutical Co., Ltd., pill and ointment will be transferred to Guangdong Fengchun Pharmaceutical Co., Ltd., and other dosage forms belong to Guangdong Yili Luoding Pharmaceutical Co., Ltd According to Xianda data v3.1, from 2002 to now, the frequency of change of drug approval number caused by technology transfer is estimated to be more than 50000 times From 2002 to 2015, the three main pharmaceutical formulations for technology transfer were tablets, injections and capsules Which products transfer the most technology? Glucose injection, analgin tablets, vitamin C tablets, glucose and sodium chloride injection, sodium chloride injection, compound sulfamethoxazole tablets, berberine hydrochloride tablets, paracetamol tablets, oxytetracycline tablets and Banlangen Granules, which are the basic standard configuration of each pharmaceutical factory, will definitely be packaged together with the general medicine when technology transfer With the arrival of GMP, it is believed that the transfer of drug approval number will still be very active before 2016.