Strong support for the implementation of the new GSP

Recently, the State Food and Drug Administration (CFDA) issued a notice on the implementation of the newly revised drug quality management specification (hereinafter referred to as the notice), which clearly requires that the implementation of the newly revised Drug GSP be completed by the end of 2015 Integration of two syndromes According to the notice, from now on, if any license of drug trade license or certificate of drug trade quality management standard expires, the newly revised Drug GSP shall be taken as the standard, and the wholesale and retail enterprises shall be inspected If the license meets the requirements, the drug trade license shall be renewed and the certificate of drug trade quality management standard shall be issued 》As of July 1, the newly established pharmaceutical trading enterprises, as well as the new (reconstruction and expansion) business premises and warehouses applied by the pharmaceutical trading enterprises shall meet the requirements of the newly revised pharmaceutical GSP, and the pharmaceutical trading license and the pharmaceutical trading quality management standard certificate will be issued if they meet the requirements This means that the notice on printing and distributing the provisions on the establishment of internal organizations and personnel for the main responsibilities of the State Food and Drug Administration issued by the general office of the State Council previously requires that "the two administrative licenses of the administrative license for drug trade and the certification of the standard for the quality management of drug trade will be gradually integrated into one administrative license" will be formally implemented CFDA said: "the implementation of the new revised Drug GSP is a good opportunity to promote the functional transformation, and the requirements of the functional transformation also provide strong support for the smooth implementation of the new revised Drug GSP." Step by step implementation of "good!" Several business people interviewed by the reporter praised the reform According to the measures for the administration of drug trade licenses, the validity period of drug trade licenses is 5 years It is understood that 2014 will be the peak period for the renewal of drug trade license For enterprises, the two administrative licenses to be implemented will be gradually integrated into one administrative license, which will undoubtedly save a lot of time and energy for enterprises, and also help enterprises to promote the implementation of the newly revised GSP In order to actively and steadily promote the implementation of the newly revised Drug GSP, the notice requires that all localities should formulate specific work plans based on the integration of the two permits, implement them step by step, and specify the time limit requirements: Before December 31, 2014, the wholesale enterprises dealing in vaccines, narcotic drugs and psychotropic drugs, protein assimilating preparations and peptide hormones, and the wholesale enterprises approved to accept the entrusted storage and distribution of drugs shall meet the requirements of the newly revised Drug GSP, and the qualified ones shall be renewed with the drug business license and the certificate of drug business quality management specification; if the conditions are not met, Reduce its business scope or cancel its entrusted qualification Before December 31, 2015, all pharmaceutical trading enterprises must meet the requirements of the newly revised Drug GSP, regardless of whether their "drug trading license" and "drug trade quality management standard certificate" expire Since January 1, 2016, those who fail to meet the requirements of the newly revised Drug GSP shall not continue to engage in drug trading activities CFDA requires: the provincial food and drug regulatory authorities should focus on the implementation of the newly revised Drug GSP as a key task of the current and future regulatory work, put it in an important position and put it on the agenda Challenges and opportunities The newly revised GSP has comprehensively improved the software and hardware standards and requirements of enterprise operation, introduced new management concepts and methods such as supply chain management concept and quality risk management, increased management requirements such as computer information management, automatic storage temperature and humidity monitoring, and drug cold chain management, and improved the market access threshold while ensuring drug quality, which is not only an opportunity for enterprises Encounter is also a challenge Yu Hong, Senior Quality Supervision director of China Resources pharmaceutical business group, said "Because our warehouse in Beijing is an old building, the cost of hardware transformation is relatively high." Yu Hong said, "however, since the operation is relatively early, now the basic transformation is completed, which can ensure the consistency with the requirements of the newly revised GSP." According to the reporter, in the aspect of transformation cost, the cost of wholesale enterprises and retail enterprises is different Relatively speaking, wholesale enterprises invest a large proportion in the aspect of hardware transformation, while retail pharmacies focus more on the increase of personnel cost According to the reporter, at present, in addition to large-scale enterprises, the number of enterprises that start to carry out the new revision of GSP transformation is not very large Previously, the drug supervision and administration departments of 14 provinces and cities in China summarized research information, showing that about half of enterprises have or can pass the new version certification through their own efforts, and 35% of retail enterprises have or can pass the new version certification through their own efforts "We also hope to promote industrial restructuring and improve market concentration through strict implementation of the new GSP." Shen Chaowei, senior assistant to the president of Shanghai Fuxing Pharmaceutical (Group) Co., Ltd and chairman of Shanghai Fumei Yixing pharmacy chain Co., Ltd., said At the same time, Shen Chaowei also hopes to get some policy support to encourage enterprises to become bigger and stronger and form scale effect It is reported that in order to ensure the smooth implementation of the newly revised Drug GSP, CFDA will strengthen policy research and guidance, coordinate with relevant departments, and issue corresponding incentive policies in the aspects of basic drug distribution, undertaking national pharmaceutical reserves, selecting designated pharmacies for medical insurance, etc.; explore the establishment of hierarchical and classified management system for drug trading enterprises, improve the licensed pharmacist system; and accelerate the introduction of the system Implement the supporting documents of the newly revised Drug GSP; actively carry out the training work.