2016-04-19 15:28

 

Pharmaceutical companies warning frequency Gordon blacklist, API generics to monitor key

 

[straight news network Beijing April 19 hearing, Beijing Daily) recently, the reporter was informed that the U.S. Food and Drug Administration will be two Chinese pharmaceutical companies included in the list of import alerts. According to incomplete statistics, since 2009, there have been 40 Chinese pharmaceutical companies import alert list of food and Drug Administration in the United States. The personage inside course of study points out, with landing of generic consistency evaluation policy and future share of export agents in business revenue accounts for will more and more, if a drug is Europe and the United States the relevant regulatory authorities to "ban", for the performance of the enterprise will cause an unprecedented blow.
Pharmaceutical companies warning frequency Gordon blacklist
Recently, the U.S. Food and Drug Administration of Xinxiang pharmaceutical Limited by Share Ltd and Xinxiang Tuoxin biochemical Limited by Share Ltd under import alert list. The two companies all drugs and drug ingredients (such as adenosine, choline, uridine and other pharmaceutical intermediates) exports to the United States will suffer the United States Customs "not disposal by inspection can be arrested". This means that the two pharmaceutical products a total ban on exports to the United States. It is understood, the two pharmaceutical companies were due to GMP (i.e. the standards for quality control of pharmaceutical production) on-site inspection of non-compliance was the United States Food and Drug Administration blocked the overall.
Beijing Daily reporter in Xinxiang pharmaceutical Co., Ltd.'s official website to see the company in early 2005 and Xinxiang extension new biochemical technology Co., Ltd. set up a Tuo Xin group and their subordinates of a variety of products have reached the United States Pharmacopoeia and European Pharmacopoeia standards, products are exported to America, Europe, Southeast Asia, more than 20 countries and regions, has formed an international marketing network. Beijing Business Daily reporter trying to contact the company responsible person asked the drug export is prohibited details, but the phone has no answer.
In fact, Xinxiang pharmaceutical Limited by Share Ltd boarded the U.S. Food and drug administration, black list is not alone. In March of last year, the U.S. Food and Drug Administration in the well-known domestic pharmaceutical raw materials and finished products drug manufacturer Hisun Pharmaceutical (1.266, 0.00, 0.00%) Zhejiang factory inspection found raw material medicine production of a serious deviation from the cGMP standards (international GMP standards), including laboratory data are not recorded in a timely manner and so on. At the same time, Hisun pharmaceutical in 2012-2014 is large on the content of the insufficient and excessive impurities of customer complaints, but the original data have been removed. According to the test results, the United States Food and Drug Administration will import 13 API entry warning list hisun. It is understood that the raw materials of the 13 varieties in 2015 1-8 months, the actual sales revenue in the U.S. market for 177 million yuan, originally expected 2015 9-12 months in the U.S. market sales revenue for 62 million yuan. The first half of last year, Hisun pharmaceutical net profit fell 78.33%.
Two major focus of supervision
Since 2009, has been included in Jiuzhou pharmaceutical, China Resources Sanjiu (22.70, 0.00, 0.00%) and other well-known pharmaceutical companies, including 40 Chinese pharmaceutical companies appeared in the United States Food and Drug Administration import alerts list. It is worth noting that these companies are mostly exported to the U.S. market for raw materials and generic drugs, and these two categories have become the focus of the U.S. Food and Drug Administration in recent years, the focus of supervision.
Because at present, China has become the second only to India the second largest APIs importer, there are more and more Chinese pharmaceutical companies in the United States Declaration API. But the long-term export experience does not allow enterprises to obtain a relatively relaxed regulatory atmosphere. Since last year, the U.S. Food and drug administration has greatly increased the Chinese GMP drug production base of raw materials inspector number, heavy occur frequently. In January of this year, the listed pharmaceutical companies Haixiang Pharmaceutical (10.17, 0.00, 0.00%) outside the sand plant APIs in the U.S. Food and Drug Inspection Bureau was found laboratory data integrity problems, drug temporarily unable to enter American market.
Insiders said that the U.S. Food and Drug Administration mentioned "laboratory data integrity issues", and the vast majority of by "ban" of Chinese pharmaceutical companies common problems. According to the last year in the United States and the European Union on Chinese pharmaceutical companies GMP site inspection results, the problems are mainly focused in terms of data, including data incomplete, inaccurate data and analysis report fraud, recording replacement content, copy records, date and signature is not consistent.
And generic drugs are another major focus of overseas regulation. In January last year, North China Pharmaceutical (694, 0.00, 0.00%) of the group's under first Thai pharmaceutical, Puluo Pharmaceutical (6.73, 0.00, 0.00% owned by Zhejiang Apeloa and other domestic pharmaceutical companies due to the presence of document fraud and other issues have not through the EU GMP inspection, product and thus lose access to the EU market.
Regulation will also become more stringent
"With the introduction of generic drug consistency policy, the United States and the European food and Drug Administration for the Chinese enterprises will be further tightened regulation." Beijing Ding Chen, head of the pharmaceutical consulting center Shi Lichen told the Beijing Business Daily reporter, the current export of drugs in many companies occupy a small proportion of the business, probably in the following 10%. But in the generic conformance evaluation policy officially landed, exports accounted for the proportion of business will be greatly enhanced, if at this time due to their own problems encountered in the United States and the European Union sanctions, the performance of pharmaceutical companies will have relatively large impact.
It is understood that at present, China has nearly 5000 companies, including generics companies accounted for more than 90%. And this year, the state has increased the intensity of the adjustment of the pharmaceutical industry. Now, generic pharmaceutical "draft" has been introduced, that is, the requirements of generic drugs in the future to be consistent with the quality and efficacy of the drug in the original research. The industry is expected that the future of generic drug exports may occupy more than 30% of the export business revenue. If you can guarantee the quality of drugs, then the policy for the enterprise is undoubtedly good. But if a problem arises in the drug quality, U.S. Food and Drug Administration "attachment", then the pharmaceutical companies will face an unprecedented blow.
Shi Lichen pointed out that now the United States Food and Drug Administration on China's raw material medicine and preparation of the monitoring has changed from the original random checks. In addition, the inspection of the production process of Chinese enterprises is also strengthening. With the U.S. Food and Drug Administration Regulation tighter, other countries will take warning, to intensify inspections of Chinese drugs and preparation of raw materials. The results mentioned above is "going out" the pharmaceutical companies will face more stringent checks, not "going out", will increase the "going out" difficulty, such as production line obtained FDA certification of difficulty will increase. If you want the Chinese pharmaceutical companies on the road to the sea go smoothly. On the one hand must be strict compliance with the GMP requirements of each, while strengthening is still blue ocean state independent innovation of drug research and development. On the other hand, in the United States to set up factories, mergers and acquisitions, construction of their own R & D institutions and marketing channels, but also a more sensible choice.
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