[news] direct reporting network Beijing on July 4th (first financial daily) 43 azithromycin production enterprises, at the sight of the State Food and Drug Administration released a generic reference preparation directory, the collective heart hurt - they are not found before the backup of the reference preparation name.

The selection of reference preparation is the key link of generic drug conformance evaluation. The first thing people do is to determine and buy reference formulations after the starting gun for conformity assessment. Once the reference was wrong, it was as if the competitor had made a mistake and ran farther and farther away in the wrong direction." Drug wisdom network co-founder Li Tianquan to the first financial express.

Since April 28th, the State Food and Drug Administration announced the directory of this batch, 43 companies are caught in confusion. The worst thing for them is that they may need to re - buy the formula and start on the road again, not just to reinvent the wheel.

With the mission of repaying the debt for history and letting the Chinese use quality and effectiveness to reach the level of the original research level, the consensus evaluation of generic drugs in China has been almost a year and a half. This time so many pharmaceutical companies all selected the wrong preparation, so that this drama suffered embarrassment.

Collective pressure wrong treasure

On March 2016, the general office of the State Council issued the opinions on the evaluation of the quality and efficacy of generic drugs (hereinafter referred to as the "opinions"). The document, which began with the evaluation of generic consistency, has put a lot of enthusiasm into both the government and the enterprise.

Consistent evaluation determines the fate of many medicines, as well as the fate of zombie batches. At the same time, the document also gives a lot of temptation: "through the consistency of the evaluation of drug varieties, medical insurance in the payment of appropriate support, medical institutions should give priority to procurement, and in clinical priority.". More than 3 manufacturers of the same kind of medicines have passed the evaluation of consistency, and no more varieties of conformity assessment have been selected in the areas of centralized drug purchasing".

Without consistency evaluation, there is only one end of the road, and there is a consistent evaluation and a viable way out. The rate of speed determines the size of the interest. The first round of conformity evaluation was in the national essential medicines list (2012 Edition) in 289 varieties, as the anti infection "big medicine" the azithromycin is included in it, for Azithromycin Tablets's 0.25 gram specifications.

"At the beginning of the conformity evaluation work, the state requires enterprises to record their selected reference preparations, and if they do not give advice within 60 days, we can work in accordance with the kind of filing.". After the filing, we spent 10 months on drug research, prescription process validation, and so on, and now we have entered the drug approval batch for bioequivalence (BE) test." Yiling Pharmaceutical (002603.SZ) director Morni Chang preparation room Research Institute of Finance said first.

In April 27, 2016 the inspection institute published the reference preparation record information (deadline: April 20th), 0.25 grams of specifications for Azithromycin Tablets has a total of 43 record reference preparation, we invariably choose azithromycin (Zithromax, produced by the Pfizer Inc in the United States).

Within the specified 60 day period of feedback, no one is informed that the formula should not be used as a reference preparation. The 43 companies saw the silence as their default, and they were racing against time to get the first to reach the finish line.

Just before it entered a crucial moment, the food and Drug Administration announced the fourth batch of the reference preparation directory, which determine the specifications of the azithromycin reference before the preparation is not for azithromycin but the Israeli pharmaceutical companies, Teva pharmaceuticals (TevaPharm B.V.) "Azitromycin 250 TEVA", listed in the EU, the origin of Croatia. The announcement amounts to the announcement that all 43 pharmaceutical companies have made the wrong preparations.

"All the manufacturers have chosen Azithromycin Tablets's formulation better. It's a bit of a problem, but why is there such a big deviation?" puzzled, not just Morni chang.