Shaanxi Bolin Biotechnology Co.,Ltd
On February 16, the CFDA through website disclosure: on the basis of the state council issued by the "about cancel 13 departments under the state council, the decision of the administrative licensing items" (guo fa  no. 10), cancel the Chinese herbal medicine production quality management standard (GAP) certification.
GAP is the quality standard of Chinese pharmaceutical industry which has been implemented for nearly 14 years.The production quality management standard of Chinese medicinal materials (trial) was approved by the national drug administration bureau on March 18, 2002, which will take effect from June 1, 2002.Why was it cancelled?After the GAP certification is cancelled, will there be other corresponding management measures?Will GAP certification affect other "GxP"?What will be the impact on the pharmaceutical industry after the GAP certification is cancelled?
"This is a document issued by the state council on February 3. We are implementing the decision of the state council," he said.After consulting the industry in the pharmaceutical industry, we were equally surprised to find that most of the Chinese medicine companies said they did not know about it.Analysts have multiple interpretations.
1 why was it cancelled?
In the middle of 2015, the industry is getting wind: GAP will be cancelled for more than a decade, and other regulatory measures will be replaced.After the Spring Festival in 2016, the rumor came true.
The reason for the cancellation is:
First, GAP does not meet the purpose of the management of Chinese medicinal materials.Over the years, there has been a lot of controversy among people from all walks of life in the pharmaceutical industry.At present, there exists the serious damage of traditional Chinese medicine resources and the deteriorating ecological environment.The production and base construction of Chinese medicinal materials are sporadic and scattered, which is mainly in the state of small-scale peasant economy, and lacks the coordination mechanism of industrialization and effective management.Chinese medicinal materials production technology talent shortage, production technology low and so on many problems.
At the same time, there are still some problems that need to be studied and implemented to support the standardized planting and supporting policies of Chinese medicinal materials, which leads to the unfavourable price and unreasonable price competition.On the other hand, there is a serious shortage of raw materials needed for the production of many enterprises, and the enthusiasm of both enterprises and pharmaceutical farmers is contusion.
Second, the state council is considering the policy's top-level design to integrate and streamline mandatory standards in various industries, while streamlining administration and delegating power.From 2015 to the beginning of 2016, the state council issued three articles, all emphasizing the reform and standardization work.
"The lack of standards is lagging behind, and it is difficult to meet the need for upgrading the quality and efficiency of the economy...The standard update rate is slow, and the "standard age" is more than 1 times higher than that in developed countries such as Germany, the United States, Britain and Japan.The standard overall level is not high, it is difficult to support economic transformation and upgrading.China's leading international standards constitute only 0.5% of the total international standard, and the 'China standard' is not internationally recognized.In addition, the standard cross-repeated contradiction is not conducive to the establishment of a unified market system.
Third, the GAP was cancelled associated with the direction of drug administration policy, released from the CFDA nearly stage series of regulatory measures, can it is clear that the CFDA is trying to build a scientific regulation system, changes the static cutting point regulation for the dynamic and the regulation of the whole process.The terminal market of drug quality standard is the key for the CFDA category, and as for how to manage the raw materials, auxiliary materials, how to manage Chinese herbal medicine pesticide residue and so on questions of how to manage, is the responsibility of the pharmaceutical production enterprise, should be responsible for the results of drug.
First of all, the industry for the GAP was cancelled after the deepest concern: if there is a formal certification is still short of the ideal state of Chinese medicinal materials management, then cancelled after the whole market will not completely disorder, manage a vacuum?
About the follow-up management approach, the industry has two solutions: one is the GAP certification ShengJu down place, the second is borne by the external third-party GAP certification related work, according to people familiar with the matter, the CFDA internal GAP has set up a special team, and has formed GAP draft the management of the third party certification.
There is no doubt that there will be a follow-up regulatory approach to the industry consensus, just how it has not been decided.
Second, related drug companies, especially Chinese medicine enterprises before the cost of the GAP certification has been a waste of water?Who is responsible for their losses?
According to public figures, Chinese herbal medicine GAP certification from May 7, 2004 to 2012, the state drug administration issued 16 announcement, a total of more than 70 enterprises (excluding repeat), 95 base, more than 60 varieties of traditional Chinese medicine by Chinese herbal medicine GAP certification.In 2015, CFDA approved 24 Chinese medicinal materials GAP certification.
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