Industry news

The new version of GMP involves a clear case of drug technology transfer

Time：2017-04-16 11:53:51

       Comply with the specific circumstances of the transferred drug: drug manufacturers overall relocation or merger after the relocation, the site of drug production technology of pharmaceutical production enterprises can be transferred to the new drug production enterprises; mergers and acquisitions in the pharmaceutical production enterprises, one party holds another 50% of the shares or shares, or both are the same an enterprise holding more than 50% of the equity or shares of the pharmaceutical production enterprises, the two sides can carry out drug technology transfer; pharmaceutical production enterprises to give up the factory or part of production form transformation, the corresponding varieties production technology transfer to have passed the GMP certification of enterprises, but the same dosage form all kinds of production technology is only a one-time transfer to a the pharmaceutical production enterprises。

      In accordance with regulations, injections and other sterile drug production enterprises should be in December 31, 2014, other categories of drug production enterprises should be in December 31, 2016 before the application for the transfer of drug varieties。