Recently，The National Five Ministry and Commission issued the "Notice on Accelerating the Implementation of Newly Revised the Quality Management of Drugs to Promote the Upgrade of the Medical Industry" (Draft for Soliciting Opinions) (hereinafter referred to as "Draft for Soliciting Opinions")，It is intended to support multiple aspects of the new version of the GMP enterprises and products。
 
According to the reporter's understanding，The implementation of the new version of GMP has made great progress，But there is still a gap between the expected goal，The state hopes to encourage enterprises to actively carry out the new version of GMP reform through a series of measures，Accelerate upgrade process。Specific will involve enterprises or products through the new version of GMP，Bid evaluation and pricing in bidding、During the implementation of the new version of GMP implementation, drug technology transfer and commission production。
 
Nanchang Lijian, etc., first passed the new stake online sports bettingstake betting appversion of GMP certification, is very positive for the content of the "Draft for Soliciting Opinions"，It is believed that whether to pass the new version of GMP certification as an important indicator of drug quality evaluation，As a reference significance of the bidding of drugs and other aspects, it is of great significance，can reduce the quality risk of drugs to the greatest extent，It can also effectively guide various pharmaceutical manufacturers to implement the new version of GMP，Promote industrial upgrading。
 
Encourage new GMP
 
"Draft for Consultation" once again made it clear that drug manufacturers must fully implement the new version of GMP certification before 2015，Point out at the same time，As of October 2012，A total of 535 companies have passed the new version of GMP certification，But the progress is still slow，Some companies exist in watching the mentality，Especially the sterile preparations must be passed through the authentication pressure at the end of 2013。
 
For this，SFDA hopes to pass a series of measures，Encourage and guide pharmaceutical manufacturers to meet the new version of GMP requirements as soon as possible。The main concern that attracts the attention of the company mainly includes technology transfer、commissioned production、Related clauses such as bidding pricing。
 
Specific content，"Draft for Consultation" pointed out，To encourage drug production to focus on superior enterprises，If the enterprise abandons the production of the entire factory or part of the dosage type，Transfer the existing drug technology to an enterprise that has passed the new version of GMP certification，technical reviews can be conducted by provincial bureaus、Production site inspection and quality assurance system verification，Report sfda approval。But sterile drugs such as injections should be before December 31, 2014，Other categories stake online sports bettingStake Sports Bettingsubmit a transfer application before December 31, 2016，Apply for cancellation of drug production licenses and approval number。
 
I also put forward new requirements in terms of commissioned production qualifications and approval，Sterile drugs from July 1, 2013，From January 1, 2015，The trustees are obtained by obtaining the corresponding dosage form type GMP certification，It will no longer approve its entrusted application。Approved，But the new version of GMP has not been passed within the prescribed period，Stop authorization production。Biological products and Chinese medicine injection must not be commissioned to produce。
 
Another，For the pricing of corporate products that have passed the new version of GMP。Clearly formulate and adjust prices to fully consider the impact of new GMP on the production cost of enterprises，During the specified period of time, the new version of GMP certified varieties or dosage forms，and the original national average price and the maximum retail price gap between the product of the product did not exceed 20%，Allow enterprises to automatically float the maximum retail price，but must not exceed 5%;，You can also get the difference price。
 
"Draft for Consultation" also requires，Further improving the quality evaluation system of bidding Chinese drugs，Enterprise variety or dosage passing through the new version of GMP certification，It should be used as an important indicator of quality evaluation standards，and significantly increase the scoring weight，The accounted for not less than 30%of the total score of the evaluation indicator; when the price evaluation is evaluated，The winning price allowed by the new version of GMP certification，It should be regarded as the same standard with the winning bid price of the new version of GMP certified drugs，For a certain price，Preferred purchase。
 
Looking forward to the policy of the policy
 
& ldquo; First of all，My stake betting appstake sports betting appSending this file reflects the determination of the country to implement the new version of GMP，Related companies need to see the situation of the policy。& rdquo; At the Xiamen Materials Association，Experts from Research Institutions Expert Explanation，& ldquo; Second，Various encouragement of the new version of the new version of GMP，Reflecting the real value of the new version of GMP certification。& rdquo;
 
Actually，The key link mentioned in the "Draft for Soliciting Opinions" has always been the key content that companies with relatively advanced quality management levels call on the government。For example, the relationship between the quality and pricing in the bidding of medicines will be further clarified，It is treated differently to ensure that high -quality drugs are differentiated; enterprises also hope that technology transfer will not loosen，To revitalize the idle approval or get a new product field，Further occupying market share; I hope to commission production and other methods，To better achieve production capacity deployment and resource utilization efficiency, etc.。These are all policies that have an important impact on the future development model of the entire industry。
 
The first batch of Fu Xiaoming, general manager of Nanchang Lijian Pharmaceutical, through the new version of GMP, has a high overall evaluation of the document，& ldquo; The pharmaceutical factory is currently not active in the new version of GMP because they do not see the benefits and value brought by the new GMP，Especially the quality review in bidding does not reflect the advantage。& rdquo;
 
Fu Xiaoming said，The file gives a higher score in the bidding pricing and quality evaluation of the new GMP products，Under the current incomplete drug quality evaluation system is the best way。
 
& ldquo; I care about drug technology transfer，We are fully adjusting stake online sports bettingthe product structure，I hope Stake Sports Bettingthat it will be bigger in the field of antibiotics。In the future, the market structure will inevitably focus on concentration，The documents of the National Bureau are equivalent to opening a small mouth，Hope in the future can be larger。& rdquo;，Another antibiotic manufacturer said that it is said。
 
However, there are also companies that make suggestions on the content of the document，For example, a manufacturer who has not passed the new GMP stops the registration and approval of its related products，Change to the allowance of the new GMP to queue up separately.。(Yang Junjian)