The new version of the GMP certification time node will reach the largest "flight check" for pharmaceutical companies.
According to the incomplete statistics of the Beijing Business Daily reporter, as of yesterday, 100 pharmaceutical companies have been reclaimed GMP certificates (the "Good Manufacturing Practices"), far exceeding the 50 last year. Among them, Chinese medicine companies accounted for 63%. The industry believes that with the approach of the new GMP certification limit, the reshuffle of the Chinese medicine industry is also accelerating.
Double the amount of drug deduction
According to incomplete statistics released by the Beijing Business Daily reporter on the GMP-certified enterprises issued by the State Food and Drug Administration, as of yesterday, 100 pharmaceutical companies in 19 provinces have been reclaimed GMP certificates, of which 63 companies are producing Chinese medicine and Chinese medicine decoction pieces. The reasons for the recovery of GMP certification include production record fraud, inspection record fraud, over-production of Chinese medicine decoction pieces, production management confusion, illegal production of Chinese medicine decoction pieces, and major defects in the quality management system.
Last year, only 50 companies were confiscated GMP certificates, but the number of companies that have been confiscated certificates has doubled this year. In this regard, Shi Lichen, head of Beijing Dingchen Medical Management Consulting Center, believes that the state has increased supervision this year. Investigating the strength of the work, this also made many "leaked net" enterprises in the last year's inspections in this year's inspections, and the number has also increased accordingly.
The certificate renewal deadline will be
It is understood that the new version of GMP certification has two time nodes: enterprises that produce blood products, vaccines, injections and other sterile drugs should reach the new GMP requirements by December 31, 2013; other categories of drugs represented by Chinese medicine and traditional Chinese medicine pieces The production companies should meet the new GMP requirements by December 31, 2015. Enterprises that fail to meet the requirements may not continue to produce drugs after the specified period. This means that if Chinese medicine companies do not want to face the dilemma of factory shutdown, they must pass the above inspection before the end of this year.
The data shows that among the 100 companies that have been repossessed, 63 are Chinese medicine and Chinese medicine decoction enterprises. According to industry insiders, Chinese medicine enterprises have become the cause of the “receiving of licenses”. On the one hand, the State Food and Drug Administration has listed Chinese medicine enterprises as the key inspection targets in the “flight inspection”, and stepped up before the “big limit is coming”. The pharmaceutical factory carries out the inspection and cleanup of the GMP situation; on the other hand, although the Chinese medicine production implements the GMP compulsory certification, compared with the preparation production enterprises, the traditional Chinese medicine and Chinese medicine decoction pieces production enterprises generally have problems such as low production quality management. The phenomenon of sub-packaging or changing labels, leasing licenses, and virtual bills has occurred frequently. Even some companies are still committing crimes after being confiscated.
On March 27 this year, the State Food and Drug Administration issued a notice saying that in the "flight inspection", it was found that 10 Chinese medicine decoction production enterprises such as Ren'an Medicine had illegal and illegal problems in production and operation. In this regard, the State Food and Drug Administration has notified 10 pharmaceutical companies and has recovered the GMP certificate. One of the companies, Taiyuan Chinese Medicine, continued to organize production after the certificate was confiscated. Therefore, this year, the State Food and Drug Administration has also increased the frequency and intensity of the “flight check”.
With the advancement of the new GMP certification and the approaching of the deadline, the industry believes that the pharmaceutical industry, especially Chinese medicine companies, will usher in an opportunity to reshuffle. Shi Lichen said that since the Chinese medicine industry has always had the bad phenomenon of “bad money expelling good money”, many small pharmaceutical enterprises have seized the low-cost and seized the market through fraudulent and shoddy, which led to large enterprises facing bad competition. There is nothing to do with it, and it has also created a chaotic situation in the market. It is now helpful to expel these “black sheep” through high-density “flight checks” and confiscation of GMP certificates.
In addition, Shi Lichen pointed out that while the GMP certificate was confiscated, more companies simply abandoned themselves and waited for “closed doors”. “Because of the fierce market competition, some small enterprises and small pharmaceutical companies cannot meet the new GMP certificate. Requirements, so simply wait for the certificate to expire at the end of this year, stop the product line, and transform to other areas."
(Jilin Qijian Biotechnology Co., Ltd. www.qjbio.com.cn)