The State Food and Drug Administration launched the new version of the Pharmaceutical GMP certification in March 2011 ("Specification of the Quality Management of Drug Production"，and requires two stages to be divided into two stages: blood products、Vaccine、Production of sterile drugs such as injections，The new version of the drug GMP requirements Stake Sports Bettingstake betting appshould be met before December 31, 2013; the production of other categories of drugs should meet the new version of the drug GMP requirements before December 31, 2015。Enterprises (workshops) that have not reached the requirements of the new version of the drug GMP，Do not continue to produce drugs after the above specified period。

 

 

This section refers to the EU relevant standards in the hardware part、The software section refers to the certification formulated by the relevant standards of the US FDA，From the beginning, it is considered to promote the re -shuffle in the pharmaceutical industry。

 

 

Current，With the new version of GMP certification, it is approaching，The regulatory authorities have increased the frequency of flight inspection。According to incomplete statistics，As of the end of October this year，Nearly 100 pharmaceutical companies across the country have been recovered by GMP certificate，Among them, 63 Chinese medicines produced by Chinese medicine and Chinese medicine tablets，far exceeding 50 in 2014。

 

 

The impact of being recovered by GMP has also appeared。The Center for Supply and Guarantee of the Pharmaceutical Supply of the Army Recently disclosed the "Notice on Publicizing the Pharmaceutical stake sports betting appMy stake betting appOnline Pharmaceutical Online Purchase and Not Production Enterprises and its varieties"，Strict means for the two situations: First, the production enterprise rises with the original auxiliary materials、Raw material shortage、Agent change、Company integration、Product sales are too low、Product process change、Reasons for production equipment maintenance does not perform the contract，Cancellation of the selection of this variety is eligible and included in the blacklist of breach of contract，Blacklist & rdquo;，Related enterprises will deduct business reputation in the centralized procurement of military drugs in the future; second, due to the new version of GMP authentication of manufacturers，For the transformation of the production workshop or fail to pass the new version of GMP certification, it cannot be supplied normally，The procurement qualification of this variety will be suspended。In the end, a total of 251 drugs were terminated for military standards，Among them, 63 companies are because of the blacklist on the new version of GMP certification。

 

 

In the first round of certification on December 31, 2013，There are nearly 40%of the sterile drugs (in the statutory drug standards, there are preparations and raw medicines for My stake betting appstake betting appsterile inspection items，Including aseptic API、injection、Vaccine、Powder injection、Blood Products, etc.) Production enterprises failed to pass smoothly。In this round of certification，The greatest influence of Chinese medicine companies。

 

 

& ldquo; There are too many Chinese pharmaceutical factories，Defined industry，good and bad。Especially Chinese medicinal materials and Chinese medicine drinks，There are still many irregular production，The capacity of the production capacity is excessive。New version of GMP certification In addition to standardizing products，Improve quality，It can also be eliminated by the industry through improvement requirements and standards。& rdquo; The person in charge of a pharmaceutical listed company said，Set the GMP threshold to standardize the industry，Industry integration will play an important role。

 

 

In fact，Reform GMP needs to invest tens of millions or more funds，For small and medium -sized enterprises that lack competitiveness in some products itself，Dashable investment is difficult to recover。Some companies do not want to give up，But for the reasons for investment and returns，It is still possible to choose to give up。