Banned 11 months, Pan Fu Shu resumption of imports

Medicine Network February 28 hearing a drug recovery.

On February 27, the State Food and Drug Administration released the Notice on the Resumption of Importation of OM Pharma SA Microbial Soluble Products Capsules (No. 29 of 2018).

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It is this medicine (Pan Fu Shu), 11 months after being banned, with immediate resumption of import.

The General Administration said that after the publication of the Notice on the Cessation of the Importation of OM Pharma SA Bacterial Dissolution Products Capsules (2017 No. 30) on March 20, 2017, enterprise After the rectification and reform, the requirements have been fulfilled and the supplementary application of the relevant changes has been approved by the SAFE. On September 26, 2017,drug Supplementary application for approval. "

FDA at all ports of entry is required to resume the import clearance of the OM Pharma SA bacterial lysate capsules from the date of publication of the report. 'Pan Fu Shu' is used for immunotherapy to prevent recurrent respiratory infections and acute exacerbation of chronic bronchitis Can be used as a combination therapy for the treatment of acute respiratory infections.

The logic of the announcement of the General Administration is very concise - overseas fly inspection found that the problem, ban; after the rectification of the pharmaceutical enterprises qualified release! In fact, in 2017 the total import banned by the General Administration of drugs a total of five.

On October 31, 2017, B. BraunMelsungen AG medium-chain fat emulsion / amino acid (16) / glucose (16%) injection and omega-3 fish oil medium / long chain fat emulsion injection 3 specifications have been suspended for sale, stop importing;

On the 24th of October 2017, the General Administration announced that one ganglioside produced from gegen (Shi Jie Yin) was banned. On June 2, 2017, one ganglioside (remodeling Jie) in Brazil was banned. On March 20, 2017, the import of bacterial lysate capsules (Pan Fu Shu) from OM Pharma SA in Switzerland was discontinued.

Further back, from 2013 to 2016, there are 9 drugs banned.

In accordance with the Administration's logic, the above products have the potential to resume imports, of which the most likely should be 'remodeling Jie and Shi Jie Yin'.

Although this product is mainly monitored by the auxiliary drug, sales have been declining, but the market is still substantial.

Gangliosides is currently one of the best-selling drugs in China, the data show that in 2016, monosialotetrahexosyl ganglioside sodium for many years occupy the top TOP100 list, in 2016 the species in the grade hospital Terminal's annual sales exceeded 10 billion yuan for the first time.

Well, Switzerland's Pan Fu Shu imported back, then the more popular 'remodeling Jie and Shi Jie Yin' will not be followed? Most likely.