Medical network - on March 21, "hua", national food drug safety administration of a loaded, and on the imported drugs.
A shot, a imported products go down! This is the first in 2017, I'm afraid I won't be the last.
▍ fall a imported drugs, selling 80 million last year
A public announcement on March 20, administration, stop importing "pan fu shu". It is understood that the products produced in Switzerland OM Pharma SA, known as: bacteria solute capsules. Used for immunotherapy; Can prevent recurrent infection and chronic bronchitis acute respiratory tract; Can be used as acute respiratory infection drug combination of treatment.
This product before and after entering China in 2008, has sold nearly 10 years. "Fu shu", related data show that turnover in 80 million yuan in 2016, domestic companies generic application, domestic main agent company is a wholly foreign owned pharmaceutical distribution company based in Shanghai.
Administration announcement, according to the on-site inspection, found that the variety of fermentation process, fermentation conditions change, change cracking step blending process change not in accordance with the "drug registration management approach" the provisions of annex 4. Violated the violated the pharmaceutical administration law of the People's Republic of China and related regulations. Administration decided to stop importing "pan fu shu", requests the port drug administration to stop the import customs clearance for the record.
▍ 10 imported drugs are banned, and the production process is the main reason
This kind of product be banned with "record"!
On January 22, 2016, the administration announced banned the import of the Italian beth di bacteria in big pharma solute (trade name: net). In fact, this product in January 2016 was listed as overseas on-site inspection. "Fu shu" if last year was found out, presumably not released until now. So, the reasonable explanation is: the administration of overseas inspection on imported products, the density increased.
On an important occasion, deputy chief of the general administration of wu said: to conduct on-site inspection abroad realize China drug regulatory pass forward. Since 2011, six years were examined in 22 countries pharmaceutical production enterprise. Indeed, in the administration over the 10 banned the import of products, there are six happened in January 2016 to the present time periods. Banned 10 drugs, process problems stand out. (see the appendix of furniture list for detail)
▍ process verification this pass, however, don't sell drugs
Don't let this product sold in the domestic, the main problem is the production process according to the regulations. Administration of holding the record of data field roadmap, found in.
To this, the blue parker consultation with experts in the field of pharmaceutical production, the conclusion is: the problem is the common fault of the domestic pharmaceutical companies, especially the proprietary Chinese medicine enterprise. "According to the production technology of enterprises for the record, most of the products is the production not to come out of" the expert said that "the content of raw material is changing, kui completely in accordance with the registration process is".
Process for verification of drug firms "killer". Fly of the administration recently issued announcement, five of which drug firms have been checked, the first is the problem of production process, and the resulting add and so on a series of illegal violations.
Ban, GMP certificate, administration process verification power all show this year. Domestic and foreign drug firms alike, beyond this, the medicine could not be sold!
Add: be banned the import of drugs
|
