1. The current GSP is issued by the State Drug Administration in the implementation of a mandatory administrative regulations, is China's first into the scope of the law of the GSP. The past GSP is issued by the state-owned main channel of the higher management or the pharmaceutical industry authorities, with the obvious color of the industry management, is only a recommendatory industry management standards.
2. The current GSP management of the scope of commodities into the international standards, and the "Drug Administration Law" management of the scope of the drug is completely consistent. In the planned economy due to the existence of pharmaceutical business sector of the pharmaceutical business and herbal medicine business two systems, GSP by the pharmaceutical industry authorities to develop, naturally, the scope of management of the GSP is determined for the four major categories of pharmaceutical commodities, drugs, medical devices, chemical reagents and glass instruments. Compared with the international practice, on the one hand, the last three categories of non-pharmaceutical pharmaceutical commodities, on the one hand, in the scope of drugs and can not cover all the drugs (i.e., does not include traditional Chinese medicine). Later, the State Administration of Traditional Chinese Medicine had also formulated the GSP and its acceptance rules for traditional Chinese medicine, but it was hardly implemented. The GSP issued by the State Drug Administration will change the scope of its management into a simple and extend the full range of drugs, not only with the international GSP, but also with the "Drug Administration Law" in the concept of drugs in full consistency. GSP's Chinese name from the "Pharmaceutical Commodity Quality Management Standard" to "Drug Business Quality Management Standard".
3. The current GSP in the structure of the document on the quality of drugs wholesale and retail of drugs, respectively, set up a chapter expression, to facilitate the actual implementation. In the past, the GSP did not have separate requirements for wholesale and retail of drugs, which brought some conceptual ambiguity and operational inconvenience to the actual implementation.
4. The current GSP more fully absorbed the theoretical achievements of modern quality management, in particular, the drug business enterprises to establish a quality system, and the basic requirements for its effective operation. In the structure of the quality system components and the drug business process is closely integrated, the line is very clear and smooth.
5. The current GSP in the specific management of the content of some bold trade-offs, remove some unrealistic requirements, so that it is more practical guidance. For example, decisively deleted the original GSP "comprehensive quality management" (TQC) of the relevant content. Strictly speaking, the management scope of TQC is much larger than the GSP, and fully encompasses the GSP, in the GSP requirements to implement TQC is illogical. At the same time, GSP is a specific management standard, and TQC is a set of management theory and methodology, in the specific management standards in the rigid implementation of a management theory and methodology, is not very appropriate. In the "give" at the same time, but also the new "take" some very practical requirements, such as the "direct transfer of drugs" requirements.
6. The current GSP and some of the newly released administrative regulations on drug management have been better convergence. For example, reflecting the "prescription drugs and non-prescription drugs classification and management methods", "drug circulation supervision and management methods (provisional)", "imported drugs management methods" and other administrative regulations of the relevant management requirements.
7. The main body of the supervision and implementation of the current GSP has become the drug administration and law enforcement departments, which ensures that the GSP is fully implemented in all drug business enterprises in the whole society. In the past, although the GSP requirements in all drug companies to implement, but due to the supervision and implementation of the means of ineffective, only in the state-owned drug companies have been implemented to a certain extent, the current GSP by the supervision and implementation of drug supervision and management departments can ensure that it is in the whole society in the full implementation of the drug business enterprises. In addition, the implementation of GSP by the way to engage in the past GSP-qualified enterprises and standardized enterprises to the implementation of a more scientific and standardized GSP certification system.
8. The current GSP is a technical barrier to drug market access. In order to speed up the implementation of the GSP and reflect the implementation of the GSP mandatory, the implementation of the GSP will be combined with the drug business enterprise business qualification confirmation, the GSP has become a measure of a licensed drug business enterprise whether to continue to operate the qualification of a hard lever of the drug market access has become a technical barrier. Drug supervision and management departments organized by the drug business enterprises to carry out the work of renewal of the acceptance criteria used for the renewal, in fact, is the implementation of the GSP a minimum standard.