National Food and Drug Administration Note [2013] No. 38 

 
Each province、Autonomous Region、The Food and Drug Administration (Drug Supervision and Administration Bureau) of the Municipality and Xinjiang Production and Construction Corps (Drug Supervision Administration):

To implement the State Food and Drug Administration、National Development Reform Commission、The Ministry of Industry and Information Technology and the Ministry of Health's "Notice on Accelerating the Implementation of New Revised Drug Production Quality Management Standards for Promoting the Upgrade of the Medicine Industry" (Guo Food and Drug Administration [2012] No. 376) The relevant provisions of the transfer of traditional Chinese medicine technology transfer，Now the overall relocation of the new revised drug production quality management specification (drug GMP) process、Merge and other situations involved in the transfer of pharmaceutical technology transfer notifications as follows:

a、The following situation，Apply for drug technology transfer:
stake online sports betting(Stake Sports Betting1) The overall relocation of the pharmaceutical manufacturer or the overall relocation after being merged，The drug production technology of the original drug production enterprise can be transferred to the new site drug production enterprise。
(2) A merger and reorganization of Chinese medicine manufacturers holds more than 50 % of the other party or shares of the other party，Or both parties to control more than 50%of the equity or share of the same enterprise or pharmaceutical manufacturer，Both sides can transfer drug technology for transfers。
(3) Abandoned the pharmaceutical manufacturers of the entire factory or some dosage production transformation，The corresponding variety production technology can be transferred to an enterprise that has passed the newly revised drug GMP certification，But the production technology of all varieties of the same dose type is limited to a one -time transfer to a pharmaceutical manufacturer。Give up the transformation of the raw material drug GMP，The corresponding drug varieties can be used for technology transfer，After the transferor is transferred to accept the transfer, the newly revised drug GMP authentication。
Sterile drug manufacturers such as injection should be before December 31, 2014、Other categories of pharmaceutical manufacturers shall submit a drug technology transfer registration application in accordance with the above requirements before December 31, 2016，Overdue drug supervision and management department will not accept it。

2. Procedures and requirements:
Drug technology transfer in line with the above situation，Application for the transfer of drug technology in accordance with the rules of the product，varieties applying for drug technology transfer are accepted、Review and get approved before listing to sell。
(1) Acceptance of the application of drug technology transfer。Drug technology transfer shall be approved by the provincial pharmaceutical supervision and management stake betting appstake online sports bettingdepartment where the pharmaceutical production enterprise is located，A supplementary application for the transfer of drug technology to the provincial drug supervision and management department of the local area from the transfer of the pharmaceutical production enterprise in which it is located，After the drug supervision and management department is reviewed and consent，Send to the acceptance notice。
(2) Approval and approval of drug technology transfer applications。After the application of drug technology transfer application is accepted,Transfer to Fang Drug Production Enterprise to complete the relevant technical research work in accordance with the rules of the product，and proposes to the provincial drug supervision and management department where the local area is located to carry out follow -up technical review work。Provincial drug supervision and management department in accordance with the requirements of the "Regulations on the Registration of Registration of Drug Technology"，Combined with the completion of the relevant requirements of the original drug approval document，Organize technical review，Production site inspection and sample inspection，Meeting the requirements，Put forward the opinions to the production and listing and report to the State Food and Drug Administration。The National Food and Drug Administration issued a supplementary application approval，Introduction to the approval number of medicines，Simultaneous cancellation of the original pharmaceutical approval number。
The changes in the scope of drug production license，Provincial drug supervision and management department nuclear production scope of production or cancel the original pharmaceutical production license。

3、belonging to the following situation，No drug technology transfer:
(1) The legal registration of the transfer of the transfer or the relevant legal registration，If you cannot bear civil liability independently;
(2) If all holders who have not obtained the new drug certificate are agreed to transfer;
(3) The transferor and the transfer party cannot provide effective approval documents;
(4) Anesthesia drugs、Stake Sports BettingMy stake betting appThe first type of psychotropic medicine、The second type of psychotropic drugs and drugs and drugs are easy to make toxic chemicals;
(5) The State Food and Drug Administration considers other situations that do not accept or not be approved。

4、Biological products shall be transferred in accordance with the procedures and requirements of the "Regulations on the Registration of Drug Technology Transfer"。

5、Provincial drug supervision and management departments must establish corresponding technical review institutions and work mechanisms，Equipped with specialized personnel and technical force,Application of the above -mentioned conditions to carry out the above -mentioned conditions to carry out the above -mentioned drug technology transfer review related work，Only approved can be implemented。Provincial drug supervision and management departments must strengthen responsibility，Strictly follow the notice requirements to carry out technical review work，Careful review of process verification、Research information such as quality comparison，Not meeting the requirements，Resolutely will not be approved，Make sure that the standard of technical transfer process is not reduced，Make sure the consistency of the quality of technical transfer varieties。
The State Food and Drug Administration will carry out supervision and inspection on the review and approval of the drug technology transfer review of various provincial drug supervision and management departments，For violating regulations、Correction of reducing technical requirements，Responsibility。

6、Drug technology transfer is currently an important job，It is to encourage the orderly flow of drug technology，Promote the successful implementation of the newly revised drug GMP，Promote the Optimization of Enterprise Resources、Enterprise bigger and stronger、Important measures to promote industrial concentration and the upgrade of the pharmaceutical stake sports betting appstake betting appindustry。Drug supervision and management departments at all levels should stand at a global height，Strengthening guidance、Eliminate interference、Prevent local protection、No obstacles must be set up for any reason，Support enterprises to carry out technology transfer，Promoting the healthy development of the pharmaceutical industry。

National Food and Drug Administration
February 22, 2013