Introduction: Speaking of the term "technology transfer", I can find the earliest regulations that have been invalidated in 1999, "Provisions on New Drug Protection and Technology Transfer." The technology transfer of the year was limited to “new drugsâ€, referring to the owner of the new drug certificate (original), transferring the new drug production technology to the production enterprise. Moreover, enterprises that accept the transfer of new drug technology may not re-transfer the new drug.
For new drugs that simply change the dosage form, in principle, the application for transfer of new drug technology will no longer be accepted; for other types of new drugs, if more than three units are declared to produce the new drug, the application for transfer will not be accepted. The regulations of the year did not mention the technology transfer in the approval of pharmaceutical production for many years.
Release of approval in 2009
The release of technology transfer approval for pharmaceutical production began with the 2009 Notice on Printing and Distributing Registration Regulations for the Transfer of Pharmaceutical Technology. For the first time, the notice divided the transfer of pharmaceutical technology into new drug technology transfer and drug production technology transfer.
The permitted transfer of the drug approval number must meet one of the following:
(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 The preparation does not have a monitoring period; only the "New Drug Certificate", the preparation that has not entered the monitoring period of the new drug, or the raw material drug that does not have a monitoring period under the "New Drug Certificate", since the date of issuance of the "New Drug Certificate", The monitoring period established by the registration classification of the corresponding preparations in Annex VI of the Measures for the Administration of Drug Registration has expired;
(2) If the variety of the New Drug Certificate is not obtained, the transferor and the transferee shall be pharmaceutical production enterprises that meet the statutory conditions, and one of the parties holds more than 50% of the shares or shares of the other party, or both parties are the same pharmaceutical manufacturer. Holding more than 50% of subsidiaries;
(3) The variety that has obtained the "Imported Drug Registration Certificate", its production technology can be transferred from the original imported drug registration applicant to the domestic pharmaceutical production enterprise.
This means that the 2009 regulatory requirements stipulate that if you want to obtain approvals for the production of pharmaceuticals for domestic manufacturers that have been on the market for many years, you can only take the road of holding.
Listed companies, state-owned enterprises act early
From 2009 to 2012, the name of the manufacturer changed due to the change in the equity of the original company. For example, on August 18, 2010, Zhitong Pharmaceutical Holding Group completed the acquisition of Baoding Sanjiu Jiishi Biopharmaceutical Co., Ltd. by means of capital increase and share expansion, and changed its name to Hebei Zhitong Bio-Pharmaceutical Co., Ltd. Upon completion of the acquisition, Zhitong Group holds a 51% stake in Zhitong Biopharma. Since 2010, the original product approval number of “Baoding Sanjiu Jiishi Biopharmaceutical Co., Ltd.†has been changed to “Hebei Zhitong Bio-Pharmaceutical Co., Ltd.â€.
Chenxin Pharmaceutical officially left the name of “Lukang Group†to seek independent listing. Since 2011, the relevant product names have been successively “Shandong Lukang Chenxin Pharmaceutical Co., Ltd.â€.
In fact, the renaming of the production enterprises corresponding to the large-scale drug approval number after 2010 was mainly due to the equity reform and mergers and acquisitions of large state-owned enterprises.
Since 2010, the Chinese medicine industry has been operating frequently. China National Pharmaceutical Industry Co., Ltd. and Sinopharm Group Xinjiang Pharmaceutical Co., Ltd. have realized the restructuring and restructuring of the original Xinjiang Pharmaceutical Factory in the form of capital increase and share expansion, and established the establishment of Sinopharm Group Xinjiang Pharmaceutical Co., Ltd. The 263 drug approval approval number changes.
The drug approval number of Sinopharm Holding Star Shark Pharmaceutical (Xiamen) Co., Ltd. after the reorganization on November 2, 2011 came from Xiamen Star Shark Pharmaceutical Co., Ltd., Xiamen Cod Liver Oil Factory and Xiamen Jianfa Pharmaceutical Co., Ltd., corresponding approval 214 Article. In a similar situation, on June 17, 2010, Jilin Yixin Pharmaceutical Co., Ltd., which was controlled by Sinopharm Holding Co., Ltd., was renamed as Sinopharm Yixin Pharmaceutical Co., Ltd., and became the anti-tumor specialized platform of Sinopharm Group.
The China Resources Department is also integrating M&A. In 2010, China Resources Department included China Resources Shuanghe and changed the approval number of 82 related drugs. In addition, Sanjiu Pharmaceutical joined the China Resources Group in 2008. In February 2010, “Sanjiu Pharmaceutical Co., Ltd.†was officially changed to “China Resources Sanjiu Pharmaceutical Co., Ltd.â€.
After that, before the name change of the manufacturer with the name "Sanjiu" before 2010, the first four words must be "China Resources Sanjiu", such as "Sanjiu Huangshi Pharmaceutical Factory" 116 drug approval number changed to "China Resources Sanjiu (Yellowstone) "Pharmaceutical Co., Ltd."; "Hunan Sanjiu Nankai Pharmaceutical Co., Ltd." changed to "China Resources Sanjiu (Zhangzhou) Pharmaceutical Co., Ltd." corresponding to 45 drug approval documents.
The drug transfer that has been listed for many years is further related to the Notice of the State Food and Drug Administration in October 2013 on the Relevant Matters Concerning the Transfer of Pharmaceutical Technology in the Process of Implementing the Newly Revised Quality Management Regulations for Pharmaceutical Production.
The notice further liberalizes the transfer of approvals for pharmaceutical production that have been on the market for many years:
(1) If the pharmaceutical production enterprise is relocated as a whole or is relocated after the merger, the pharmaceutical production technology of the original pharmaceutical production enterprise may be transferred to the new pharmaceutical production enterprise.
(2) If the pharmaceutical production enterprise in the merger and reorganization holds more than 50% of the shares or shares of the other party, or both parties are pharmaceutical production enterprises that hold more than 50% of the shares or shares of the same enterprise, the two parties may transfer the technology of the drug.
(3) A pharmaceutical production enterprise that abandons the whole plant or part of the production and transformation of the dosage form may transfer the production technology of the corresponding variety to the enterprise that has passed the newly revised drug GMP certification, but the production technology of all varieties of the same dosage form is limited to one-time transfer to one drug production. enterprise. If the GMP modification of the raw material drug is abandoned, the corresponding drug product may be transferred to the technology, and the transferee shall accept the transfer and then carry out the newly revised drug GMP certification.
Sterile pharmaceutical manufacturers such as injections should submit an application for registration of pharmaceutical technology transfer according to the above requirements before December 31, 2014, before December 31, 2014.
Foreign companies started to take action
Since 2013, the form of technology transfer of drug approval documents has begun to diversify, foreign companies have begun to take action, listed companies and large state-owned enterprises are still in the layout, and SME transactions are more active than in 2010.
Such technology transfer is still underway due to changes in the name of the stock change. For example, “Beijing Shuanghe Pharmaceutical Co., Ltd.†and “Beijing Shuanghe Modern Medicine Technology Co., Ltd.†were renamed as “China Resources Shuanghe Pharmaceutical Co., Ltd.†Ltd.". Kangzhe acquired a 51% stake in Guangxi Guangming Pharmaceutical Co., Ltd. (which was officially renamed as Guangxi Kangzhe Guangming Pharmaceutical Co., Ltd. on October 10, 2011) in cash. "15 approval documents were renamed "Guangxi Kangzhe Guangming Pharmaceutical Co., Ltd.".
The case of the transfer of the whole factory approval personally inferred that the 15 approval documents of “Huangshi Li Shizhen Pharmaceutical Group Wuhan Xinsu Pharmaceutical Co., Ltd.†were transferred to “Fresenyuskabi (Wuhan) Pharmaceutical Co., Ltd.†in 2013.
The regulations allow for the transfer of dosage forms, and there will be different manufacturers of different dosage forms. For example, Guangdong Luoquan Pharmaceutical Co., Ltd., pills and ointments are transferred to Guangdong Fengchun Pharmaceutical Co., Ltd., and other dosage forms belong to Guangdong Yililu Custom Pharmaceutical Co., Ltd. .
According to the Hada Data V3.1, from 2002 to the present, the frequency of changes to the name of the drug approval number due to technology transfer is expected to exceed 50,000. The three major pharmaceutical dosage forms for technology transfer from 2002 to 2015 were mainly tablets, injections and capsules.
Which product technology transfer has the most? Glucose injection, An Nai near tablets, vitamin C tablets, glucose sodium chloride injection, sodium chloride injection, compound sulfamethoxazole tablets, berberine hydrochloride tablets, acetaminophen tablets, oxytetracycline tablets and Banlangen Granules must have the basic standard configuration of each of these pharmaceutical companies. When the technology is transferred, it will definitely be packaged with the generic medicine. With the arrival of the GMP deadline, it is believed that before 2016, the drug approval number transfer transaction will remain very active.
For new drugs that simply change the dosage form, in principle, the application for transfer of new drug technology will no longer be accepted; for other types of new drugs, if more than three units are declared to produce the new drug, the application for transfer will not be accepted. The regulations of the year did not mention the technology transfer in the approval of pharmaceutical production for many years.
Release of approval in 2009
The release of technology transfer approval for pharmaceutical production began with the 2009 Notice on Printing and Distributing Registration Regulations for the Transfer of Pharmaceutical Technology. For the first time, the notice divided the transfer of pharmaceutical technology into new drug technology transfer and drug production technology transfer.
The permitted transfer of the drug approval number must meet one of the following:
(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 The preparation does not have a monitoring period; only the "New Drug Certificate", the preparation that has not entered the monitoring period of the new drug, or the raw material drug that does not have a monitoring period under the "New Drug Certificate", since the date of issuance of the "New Drug Certificate", The monitoring period established by the registration classification of the corresponding preparations in Annex VI of the Measures for the Administration of Drug Registration has expired;
(2) If the variety of the New Drug Certificate is not obtained, the transferor and the transferee shall be pharmaceutical production enterprises that meet the statutory conditions, and one of the parties holds more than 50% of the shares or shares of the other party, or both parties are the same pharmaceutical manufacturer. Holding more than 50% of subsidiaries;
(3) The variety that has obtained the "Imported Drug Registration Certificate", its production technology can be transferred from the original imported drug registration applicant to the domestic pharmaceutical production enterprise.
This means that the 2009 regulatory requirements stipulate that if you want to obtain approvals for the production of pharmaceuticals for domestic manufacturers that have been on the market for many years, you can only take the road of holding.
Listed companies, state-owned enterprises act early
From 2009 to 2012, the name of the manufacturer changed due to the change in the equity of the original company. For example, on August 18, 2010, Zhitong Pharmaceutical Holding Group completed the acquisition of Baoding Sanjiu Jiishi Biopharmaceutical Co., Ltd. by means of capital increase and share expansion, and changed its name to Hebei Zhitong Bio-Pharmaceutical Co., Ltd. Upon completion of the acquisition, Zhitong Group holds a 51% stake in Zhitong Biopharma. Since 2010, the original product approval number of “Baoding Sanjiu Jiishi Biopharmaceutical Co., Ltd.†has been changed to “Hebei Zhitong Bio-Pharmaceutical Co., Ltd.â€.
Chenxin Pharmaceutical officially left the name of “Lukang Group†to seek independent listing. Since 2011, the relevant product names have been successively “Shandong Lukang Chenxin Pharmaceutical Co., Ltd.â€.
In fact, the renaming of the production enterprises corresponding to the large-scale drug approval number after 2010 was mainly due to the equity reform and mergers and acquisitions of large state-owned enterprises.
Since 2010, the Chinese medicine industry has been operating frequently. China National Pharmaceutical Industry Co., Ltd. and Sinopharm Group Xinjiang Pharmaceutical Co., Ltd. have realized the restructuring and restructuring of the original Xinjiang Pharmaceutical Factory in the form of capital increase and share expansion, and established the establishment of Sinopharm Group Xinjiang Pharmaceutical Co., Ltd. The 263 drug approval approval number changes.
The drug approval number of Sinopharm Holding Star Shark Pharmaceutical (Xiamen) Co., Ltd. after the reorganization on November 2, 2011 came from Xiamen Star Shark Pharmaceutical Co., Ltd., Xiamen Cod Liver Oil Factory and Xiamen Jianfa Pharmaceutical Co., Ltd., corresponding approval 214 Article. In a similar situation, on June 17, 2010, Jilin Yixin Pharmaceutical Co., Ltd., which was controlled by Sinopharm Holding Co., Ltd., was renamed as Sinopharm Yixin Pharmaceutical Co., Ltd., and became the anti-tumor specialized platform of Sinopharm Group.
The China Resources Department is also integrating M&A. In 2010, China Resources Department included China Resources Shuanghe and changed the approval number of 82 related drugs. In addition, Sanjiu Pharmaceutical joined the China Resources Group in 2008. In February 2010, “Sanjiu Pharmaceutical Co., Ltd.†was officially changed to “China Resources Sanjiu Pharmaceutical Co., Ltd.â€.
After that, before the name change of the manufacturer with the name "Sanjiu" before 2010, the first four words must be "China Resources Sanjiu", such as "Sanjiu Huangshi Pharmaceutical Factory" 116 drug approval number changed to "China Resources Sanjiu (Yellowstone) "Pharmaceutical Co., Ltd."; "Hunan Sanjiu Nankai Pharmaceutical Co., Ltd." changed to "China Resources Sanjiu (Zhangzhou) Pharmaceutical Co., Ltd." corresponding to 45 drug approval documents.
The drug transfer that has been listed for many years is further related to the Notice of the State Food and Drug Administration in October 2013 on the Relevant Matters Concerning the Transfer of Pharmaceutical Technology in the Process of Implementing the Newly Revised Quality Management Regulations for Pharmaceutical Production.
The notice further liberalizes the transfer of approvals for pharmaceutical production that have been on the market for many years:
(1) If the pharmaceutical production enterprise is relocated as a whole or is relocated after the merger, the pharmaceutical production technology of the original pharmaceutical production enterprise may be transferred to the new pharmaceutical production enterprise.
(2) If the pharmaceutical production enterprise in the merger and reorganization holds more than 50% of the shares or shares of the other party, or both parties are pharmaceutical production enterprises that hold more than 50% of the shares or shares of the same enterprise, the two parties may transfer the technology of the drug.
(3) A pharmaceutical production enterprise that abandons the whole plant or part of the production and transformation of the dosage form may transfer the production technology of the corresponding variety to the enterprise that has passed the newly revised drug GMP certification, but the production technology of all varieties of the same dosage form is limited to one-time transfer to one drug production. enterprise. If the GMP modification of the raw material drug is abandoned, the corresponding drug product may be transferred to the technology, and the transferee shall accept the transfer and then carry out the newly revised drug GMP certification.
Sterile pharmaceutical manufacturers such as injections should submit an application for registration of pharmaceutical technology transfer according to the above requirements before December 31, 2014, before December 31, 2014.
Foreign companies started to take action
Since 2013, the form of technology transfer of drug approval documents has begun to diversify, foreign companies have begun to take action, listed companies and large state-owned enterprises are still in the layout, and SME transactions are more active than in 2010.
Such technology transfer is still underway due to changes in the name of the stock change. For example, “Beijing Shuanghe Pharmaceutical Co., Ltd.†and “Beijing Shuanghe Modern Medicine Technology Co., Ltd.†were renamed as “China Resources Shuanghe Pharmaceutical Co., Ltd.†Ltd.". Kangzhe acquired a 51% stake in Guangxi Guangming Pharmaceutical Co., Ltd. (which was officially renamed as Guangxi Kangzhe Guangming Pharmaceutical Co., Ltd. on October 10, 2011) in cash. "15 approval documents were renamed "Guangxi Kangzhe Guangming Pharmaceutical Co., Ltd.".
The case of the transfer of the whole factory approval personally inferred that the 15 approval documents of “Huangshi Li Shizhen Pharmaceutical Group Wuhan Xinsu Pharmaceutical Co., Ltd.†were transferred to “Fresenyuskabi (Wuhan) Pharmaceutical Co., Ltd.†in 2013.
The regulations allow for the transfer of dosage forms, and there will be different manufacturers of different dosage forms. For example, Guangdong Luoquan Pharmaceutical Co., Ltd., pills and ointments are transferred to Guangdong Fengchun Pharmaceutical Co., Ltd., and other dosage forms belong to Guangdong Yililu Custom Pharmaceutical Co., Ltd. .
According to the Hada Data V3.1, from 2002 to the present, the frequency of changes to the name of the drug approval number due to technology transfer is expected to exceed 50,000. The three major pharmaceutical dosage forms for technology transfer from 2002 to 2015 were mainly tablets, injections and capsules.
Which product technology transfer has the most? Glucose injection, An Nai near tablets, vitamin C tablets, glucose sodium chloride injection, sodium chloride injection, compound sulfamethoxazole tablets, berberine hydrochloride tablets, acetaminophen tablets, oxytetracycline tablets and Banlangen Granules must have the basic standard configuration of each of these pharmaceutical companies. When the technology is transferred, it will definitely be packaged with the generic medicine. With the arrival of the GMP deadline, it is believed that before 2016, the drug approval number transfer transaction will remain very active.
Human chorionic gonadotropin is a hormone for the maternal recognition of pregnancy produced by trophoblast cells
Human chorionic gonadotropin (HCG) is a glycoprotein secreted by trophoblast cells of the placenta And β dimer proteins. The molecular weight of glycoprotein hormone 36700, A. Pituitary, FSH, follicle stimulating hormone, LH (luteinizing hormone) and TSH (thyroid stimulating hormone) are basically similar, So they can cross-react with each other, while the structure of β subunit is not similar. In mature women, the fertilized ova move to the uterine cavity for implantation and form embryos. In the process of development and growth into the fetus, the placental syncytiotrophoblast cells produce a large amount of HCG, which can be excreted into urine through the blood circulation of pregnant women. Serum and urine HCG levels rise Rapidly from 1 to 2.5 weeks of gestation, reaching a peak at 8 weeks of gestation and dropping to moderate levels at 4 months of gestation, which remain at the end of gestation. At present, the commonly used detection methods are: latex aggregation inhibition test and hemagglutination inhibition test; Radioimmunoassay (RIA); Enzyme linked immunosorbent assay (ELISA); Monoclonal antibody colloidal gold test
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