Recently，National Food and Drug Administration、National Development and Reform Commission、Department of Industry and Information Technology、The Ministry of Health and other four ministries and commissions "Notice on Accelerating the Implementation of New Revised Drug Production Quality Management Standards for Promoting the Upgrade of the Medical Industry" has been officially issued。Instead of decreased the standard、Under the requirements of not relaxing time，Four ministries and commissions launched mergers and reorganizations、Certification inspection、review approval、commissioned production、Price adjustment、Encouragement measures in seven aspects including bidding procurement and technical transformation，Encourage and guide pharmaceutical manufacturers to reach the new revised drug GMP as soon as possible。

    March 1, 2011 Newly revised the "Specifications for the Management of Quality Management of Drug Production" (hereinafter referred to as the newly revised drug GMP)，Each region、Pocket cooperation with various departments，Increase the implementation of publicity，Some pharmaceutical manufacturers have taken the lead in certification，Play a good demonstration role。But generally speaking，There is still a large gap between the expected target，In particular, the production of sterile preparations should achieve the expected target at the end of 2013，Mission Stake Sports Bettingis stake sports betting appparticularly urgent。To encourage and guide pharmaceutical manufacturers to reach the new revised drug GMP as soon，Four ministries and commissions have launched the following seven measures。

    First, to encourage drug production to focus on superior enterprises。Support research and development and production、Manufacturing and circulation、Materials and preparations、Upstream integration between Chinese medicinal materials and Chinese medicines and other companies，Support enterprises to carry out mergers and reorganizations、Resource integration，Realize scale、intensive operation，Improve industrial concentration。Application for drug technology transfer registration that occurs in corporate mergers and reorganizations or the internal optimization resource allocation of the enterprise group，Further improve the speed of review and approval，Technical review by the provincial drug supervision and management department、Production on -site inspection and quality assurance system review。Meeting the requirements，Report to the national drug supervision and management department for approval。Drug production enterprises actively abandon the entire factory or part of the dosage production transformation，Can be according to the above requirements，Transfer its existing drug technology to an enterprise that has passed the newly revised drug GMP certification。But a dosage -type drug technology is limited to a one -time transfer to an enterprise。Sterile drug manufacturers such as injection should be before December 31, 2014、Other categories of pharmaceutical manufacturers shall apply for the application of drug technology transfer registration in accordance with the above requirements before December 31, 2016，Apply for cancellation of the corresponding drug production license and drug approval number at the same time。

    Second, encourage superior enterprises to pass certification as soon as possible。For companies or other foundations that have passed the World Health Organization or Drug Inspection International Convention Organization (PIC/S), the Drug GMP certification inspection is better、The quality assurance system is perfect、Enterprises that are not found in previous drug GMP certification inspections，Organizations and other measures through priority stake betting appstake online sports bettingarrangements，Encourage all production lines to pass the certification at one time。For the production line of drug GMP certification inspection that has passed the World Health Organization or Drug Inspection (PIC/S)，The drug supervision and management department reviews its inspection work and believes that it meets the requirements of my country's newly revised drug GMP，You can directly pass the certification。

    Third is to restrict the registration of drugs that have not passed the certified enterprise on schedule。Drug production enterprises have not passed the newly revised drug GMP certification within the specified period，The drug supervision and management department will suspend its corresponding dosage type drug registration review approval。Sterile drug manufacturers such as injection from January 1, 2014、Other categories of drug manufacturers from January 1, 2016，If the newly revised drug GMP certification certificate cannot be submitted by the corresponding dosage type，Not accepting its newly declared registration application，Such application for suspension of review approval。After the above -mentioned enterprise submits the corresponding dosage type newly revised drug GMP certification，can only accept or restart the review approval procedure。New pharmaceutical manufacturers (workshops) except。

    Fourth, strict drug commissioned production qualification review and approval。Sterile drugs such as injection from July 1, 2013、Other categories of drugs from January 1, 2015，The trustee did not obtain the corresponding dosage type newly revised drug GMP certification，The drug supervision and management department will not approve its drug entrusted production application。For the approved commissioned production，The corresponding category of the subject's category such as before or before the end of 2013 or before the end of 2015, the newly revised drug GMP certification，Stop supporting production when overdue。For enterprises that have been carried out by the newly revised Drug GMP transformation but have not yet passed the certification within the prescribed period，Enterprise production that can be commissioned by the newly revised drug GMP certification during the discontinuation of production，Sterilizers such as injection can be commissioned to be produced until December 31, 2014，Other categories of medicines can be commissioned stake sports betting appto Stake Sports Bettingproduce until December 31, 2016。Biological products and Chinese medicine injection must not be commissioned to produce。

    Five is to give full play to price leverage。When the price competent department formulates and adjust the price of drugs，It is necessary to fully consider the impact of the implementation of the newly revised drug GMP on the production cost of the enterprise。Products for newly revised drug GMP certification，Decided by the State Drug Supervision and Administration Department，To reach the international level，Implement a reasonable price tilt policy。

    Six is ​​the implementation of concentrated procurement policies for drugs。Adhere to quality priority in centralized procurement of medicines、Reasonable price。Further improving the drug quality evaluation system，The corresponding variety or dosage of the production enterprise passed the newly revised drug GMP certification as an important indicator of quality evaluation standards。In the centralized drug concentrated procurement，If you have passed the newly revised drug GMP certification manufacturer's products to participate in the bid，Other products that have not passed the newly revised drug GMP certification enterprise，No longer entered the business standard review stage;，Actively study and explore the establishment of a separate product category，and further increase the score weight of GMP certification。For drugs that perform a certain price，Priority priority to enterprises purchased from the corresponding variety or dosage type by newly revised drug GMP certification。

    Seven is supporting the GMP reconstruction project of enterprise drugs。Methods through industrial revitalization and technical transformation，Support for the newly revised drug GMP renovation project of the enterprise，Mobilize the enthusiasm of the enterprise to implement the transformation。Supporting conditions for enterprises that meet international standards that meet international standards，Organize the implementation of international certification of production quality system，Drive the level of quality assurance of drug production in my country with international standards。

    In the notification，Four ministries and commissions require drug supervision at all levels、Development Reform、Industry and Information Technology、The health administrative department Stake Sports Bettingstake sports betting apphas strengthened the coordination and coordination of various policies，Form policy synergy。At the same time，To establish a cross -departmental leadership group or coordinate meeting mechanism。To strengthen industry management and operation monitoring，Research pre -judgment and timely solving problems that may affect the normal supply of drugs，Make protection of clinical medication。Report the implementation in a timely manner，Implement relevant policies，Under the unified leadership of the local government, do a good job of implementing the new revised drug GMP to implement various tasks。Drug production enterprises that are closed due to the implementation of newly revised drug GMP，We must predict in advance，Formulate a plan，Proper disposal，Effectively maintain social stability。