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At the beginning of reform and opening up, China introduced the concept of pharmaceutical GMP. In 1988, it issued the GMP standard for pharmaceuticals and began accepting applications for certification in 1995. Since 1998, the former State Drug Administration has implemented step-by-step GMP certification according to the type of drug formulation: in 1998, it completed GMP certification for blood product manufacturers; in 2000, it completed powder injections, freeze-dried powder injections, and large-volume injections. GMP certification for genetically engineered product manufacturers; GMP certification for small volume injection manufacturers in 2002. In 2004, the company achieved the goal of organizing production of chemical raw material medicines and all pharmaceutical preparations in conformity with GMP conditions, and all companies that had not passed the certification were forced to suspend production. From January 1, 2006, the goal of organizing production of in vitro biodiagnostic reagents, medical gases, and traditional Chinese medicine decoction pieces in compliance with GMP conditions has been achieved in stages, bringing the pharmaceutical industry production level and product quality to a new level.
According to the data from the SFDA Southern Institute of Pharmaceutical Economics, before the GMP certification, there were many raw material medicines and preparations companies with small scales, scattered operations, and low management levels. In 1978, there were 1,419 raw material medicine and preparation enterprises in China, and in 1998, 3,418 were obtained. At most, it reached 5,146 in 2001. After the implementation of GMP certification, pharmaceutical manufacturing companies have grown from a total of approximately 3,731 homes at the end of 2004 to the current 5,612 raw material plants and preparations manufacturing enterprises, of which 90% are small enterprises. There are 114 companies with genetic engineering drug production capacity and 28 vaccine production companies.
From the policy level, in 2008, SFDA still focused on accelerating the implementation of the National Drug Criteria Action Plan, and planned to complete the revision of 2,000 varieties of drug quality standards, focusing on the completion and completion of revisions of the Chinese Patent Medicines (Bureau) standards, and 400 A high-risk injectable variety standards improve the work. The SFDA made it clear that: “In 2008, strict market access is required, and pharmaceutical operations cannot be done by anyone.†Thus, strict enterprise and industry access will continue to be one of the priorities of the SFDA for a long time to come. This is not only reflected in the need to strictly examine and approve products and newly established enterprises, but also to further improve the exit mechanism of enterprises. Therefore, it can be predicted that the pace of upgrading of the pharmaceutical industry will not slow down in the next few years.
In the aspect of production management, China has spent 14 years from the initiation of GMP implementation to the full implementation of GMP, which can be said to have played a key role in promoting industrial upgrading and increasing industrial concentration. Thanks to the full implementation of GMP certification for pharmaceutical products, the industry has succeeded in the survival of the fittest and the degree of industrial concentration has been greatly improved, thus enhancing the competitiveness of Chinese pharmaceutical companies in the international market.
November 28, 2023