Announcement on the Implementation of the Good Manufacturing Practice for Sterile Drugs (Revised in 2010) According to the implementation plan of "good manufacturing practice (revised in 2010)" (hereinafter referred to as the newly revised drug GMP), the production of sterile drugs such as blood products, vaccines and injections must meet the requirements of the newly revised drug GMP before December 31, 2013. The relevant matters are hereby announced as follows: 1. Since January 1, 2014, all sterile drug manufacturers or production workshops such as blood products, vaccines, and injections that have not passed the newly revised drug GMP certification will stop production. Products produced before December 31, 2013 can continue to be sold; products that have completed the final packaging before December 31, 2013 but have not yet completed the inspection can continue to be inspected and can only be sold after passing the inspection. 2. sterile drug manufacturers or production workshops that have passed the on-site inspection of the newly revised drug GMP certification before December 31, 2013 and have been publicized, they can continue production after January 1, 2014. However, its products should be available for sale only after obtaining a new GMP Certificate. 3. After January 1, 2014, sterile drug manufacturers or production workshops that have not passed the newly revised drug GMP certification must apply for certification in accordance with relevant regulations; after passing the certification, production can be resumed. Certification and inspection work will continue to maintain high standards and strict requirements to ensure the consistency of the implementation of the newly revised drug GMP. 4. food and drug regulatory departments at all levels shall, in accordance with the above requirements, strengthen the supervision and inspection of the production of sterile drugs. For those who have passed the newly revised drug GMP certification, we must increase the intensity of follow-up inspection; for those who have not passed the certification and must stop production, we must strictly prevent illegal production activities; once problems are found, we must resolutely investigate and deal with them in accordance with the law. It is hereby announced. State Food and Drug Administration December 31, 2013