According to CFDA, from 1st March 2011 start-ups and new workshop need to meet new GMP. The production of blood products, vaccines, and injection and any non-bacteria drug of existing pharmaceutical production enterprise need to meet new GMP before the end of 2013. The balance need to meet new GMP at the end of 2015. The sub-standard enterprise can not allowed to manufacture.  

    The present of new GMP certificate

    The hardware part of new GMP refer to European Union standards and software part refer toFDA standards.

     According to Shanxi FDA, the company completed new GMP  account for 60% of all companies. It means that at least 40% companies will get certificate in first half year.In the province of small and medium-sized pharmaceutical production enterprise, the certified rate is lower. Many medicine enterprises feel helplessness and give up early.

    Actually when the new GMP come, the industry has predicted it would cause drug firms shuffle. According to Yu Mingde, when buffer period is finish during 2011 to 2013, the new GMP will cause thousands of medium-sized pharmaceutical production enterprise to close down. According to history, the GMP of 1988 caused 25% pharmaceutical enterprise to exit market.

    Through the ages, China want to change small, scattered and disorderly situation through GMP. At present, China pay more and more attention to the production process of the drug.

   According to some statistics, In more than 100 pharmaceutical enterprises whose GMP are retracted, there are about 20 enterprises returned GMP.

   Manufacturing enterprises can not start to manufacture and lose bidding qualification if they don’t get the new GMP.

   Actually, enterprises have already bear huge economic pressure, especially for small and medium-sized enterprises.Manufacturing enterprises stopped the supply because of financial matter.

    What unlicensed enterprises will do?

    Some enterprises are small but they have good products. They have another way that is acquisition and reorganization. They can pass new GMP certificate under the support of large enterprises. Like shanghai pharmaceutical and Huarun pharmaceutical, those two firms have purchased some small enterprises.

    With the coming of new GMP limited, there are many firms will be the unlicensed enterprises.

    The enterprises which can not pass new GMP certificate before the end of 2015, they are facing discontinued. Because they are not reach the threshold of the registration.