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Recently, the Hepatitis B vaccines of companies such as Shenzhen Kangtai, Dalian Hanxin and Tiantan Biotech, which were known to netizens for the "suspected hepatitis B vaccine lethal infant" incident, had failed to pass the newly revised pharmaceutical GMP certification and had ceased production on January 1. The three companies were required to continue production of the product until they obtained the newly revised GMP certification.
It is reported that products produced by obsolete enterprises before December 31, 2013 can continue to be sold; final packaging has been completed before December 31, 2013, but products that have not yet completed inspections can continue to be inspected and can be sold only after being qualified.
According to the newly revised GMP implementation plan for pharmaceuticals, before the end of 2013, manufacturers of sterile drugs such as blood products, vaccines and injections must meet the requirements for the newly revised pharmaceutical GMP; before the end of 2015, all other categories of pharmaceutical manufacturers reached the newly revised pharmaceutical GMP. Claim. Therefore, from 2014 to 2015, it will be a crucial two years for non-sterile drug companies to meet the new GMP. However, for now, the chances of these drug companies applying for approval should be higher than that of aseptic drug companies.
Therefore, there are also industry insiders who expect that pharmaceutical companies will have a better market environment in the next two years. Zhong Qian, the new general manager of modern pharmaceuticals, said that in the first half of next year, aseptic drug manufacturers that have passed the new GMP certification will usher in the sales season. Zhong Qian said, "Although non-sterile drug manufacturers have passed the new GMP certification deadline, there are still two years away from now, which is relatively loose, but these two years are a good time for some companies to seize the market because of the tender policy from various places. , Non-sterile drug manufacturing companies that have passed the GMP certification are expected to benefit from the new round of tenders nationwide."
Companies outside the sterile pharmaceutical companies will enter the new GMP review stage. They believe that the experience and lessons learned from the aseptic drug company's verification process will also be absorbed by them. Therefore, the review will be more difficult than the sterile drug companies. At the same time, this will also ease the impact of the new GMP aseptic company auditing on pharmaceutical machinery companies.
In the next two years, it will be the critical period for non-sterile drug companies to face the new GMP.
According to the newly revised pharmaceutical GMP implementation plan, the production of sterile drugs such as blood products, vaccines and injections must reach the new version requirements by December 31, 2013. Since January 1, this year, production companies or production plants for sterile drugs such as blood products, vaccines, and injections that have not passed the newly revised pharmaceutical GMP certification will stop production.