Medical network - March 9 as the United States, the European Union and other developed countries the agency to check the Chinese drug firms, is now China's drug regulatory also strongly than, for the imported drugs safety, continuous overseas drug firms.
Yesterday (March 8), published by the state food and drug supervision and administration bureau in 2017 imported drugs outside production site inspection task announcement, 31 drug firms of 39 species (11 belong to the previous year task left turn) was placed on the outside the production scope of on-site inspection.
State administration of food drug safety announcement stressed that the "total bureau of national food and drug supervision and administration of the food and drug audit inspection center is responsible for carrying out the relevant inspection organization, on-site inspection is not limited to the following varieties."
This means that, outside the site inspection list will likely be expanded, not limited to already announced 39 varieties.
▍ more than 10 varieties has been banned
According to the national food administration of drug safety data, for the first time since 2011, when the Chinese drug regulatory overseas production site inspection for imported drugs, since 6 years were examined 22 countries pharmaceutical production enterprise, in the inspection found some phenomenon is not in conformity with the relevant provisions of the drug administration in our country, stopped including brain protein hydrolysate injection, love live bile through more than 10 varieties of imports, for overseas pharmaceutical companies also have the effect of a warning.
Public information display, on January 22, 2016, the state food and drug supervision and administration bureau's announcement, according to the bureau of imported drugs through organization to carry out the production site inspection found that the Italian beth di four companies such as pharmaceutical companies producing bacteria to solute (trade name: net), and four varieties exist in violation of the provisions of pharmaceutical administration law and the relevant behavior, ask for each port drug administration to stop the above four varieties of import customs clearance for the record.
Announcement said, Austria Witt pharmaceutical co., LTD., the brain protein hydrolysate injection (trade name: cerebrolysin) the actual production process with the registration process, the actual prescription add 15 kinds of amino acids is not embodied in the registration data; Japanese save heart pharmaceutical co., LTD of kyushin pills rework procedure not quality risk prevention and control, not in full production process validation, test data is incomplete, change of production site without approval; Italian beth di big pharma bacteria to solute the actual production process with the registration process, laboratory data integrity problems, the production process risk of cross contamination; Rabin degrees pharmaceutical co., LTD., India repeatedly delayed state drug administration to cephalosporin check oxime esters, force an on-site inspection.
State drug administration decided to stop the above four kinds of imported drugs. Among them, the Austrian ai Witt pharmaceutical co., LTD., the brain protein hydrolysate injection will not be registered again; By drug production quality management standard in production before the on-site inspection, to stop the other three kinds of drug related registration matters - among them, the Italian beth di large pharmaceutical factory production net since 2007 as the second type of orchid bacteria vaccine used in our country.
▍ do risk rating for imported drugs
In fact, in recent years, China for imported drugs gradually hasten is heavily regulated.
On January 25, 2017, held in the scio "further reform and improve the use policy for producing and distributing medicines of several opinions" briefing, national food drug administration deputy director wu said that in recent years, the state food and drug supervision bureau to carry out overseas inspection of imported drugs, mainly according to import some of the risks in the process of drug production, after assessment, and to comprehensive foreign inspection plan.
Wu pointed out that the focus of the foreign inspection, production process of drug production quality management standard compliance. He said that in the future, the food and drug administration of regulation will also further strengthen inspection, strictly control quality of imported drugs, urge the imported drugs production enterprise continued compliance, in accordance with relevant provisions of the our country on drug administration, ensure the quality of imported drugs and security.
And it is also on the general practice of the international drug supervision, to strengthen the drug quality control, the FDA has put its regulatory chains such as expanding into the global, many pharmaceutical companies are due to raw material problem or other national branch by global public problem.
Public data from the national food administration of drug safety shows: on January 6, 2016, the country announced the 2016 annual imported drugs outside production site inspection, a total of 49 drugs are on the check list; After in 2015 and 2014, there were 30 and 24 imported drugs have been country check number, from the overall trend point of view, clearly present check surface to expand and increase in the number of features.
Add: 2017 imported drugs outside production site inspection tasks announcement (a)
|
