The 80th Pharmaceutical Fair will kick off tomorrow in Guangzhou. As a major event in the pharmaceutical industry, about 2,000 pharmaceutical companies have hoped to take this opportunity to promote investment and expand their sales channels and corporate influence.In 2018, when the official policies such as conformity assessment, medical insurance, and 4 + 7 are frequent, the variety of conformity assessment is undoubtedly the focus of the participating agents.
According to the medical Rubik's Cube PharmaGO data monitoring, there are currently 87 varieties that have passed the conformity assessment (according to the manufacturer's distinction), and 30 have participated in this drug fair, accounting for 34%, which is rare.
How to quickly find which stand these varieties are in?To this end, we specially made a small program [assistant to the drug fair], you can check the variety, check the company, one step lock the variety booth.The important thing is that the inquiry is free and can be called the conscientious production of the industry.
Selected varieties, add attention, that is, you can "my attention" at any time to look at, one by one, the trip to Guangzhou on the task, there is wood?!
Also remind you here, be sure to keep your eyes open and not be blinded by the manufacturer's propaganda.If you go around the drug fair, you will find that the "conformity assessment" variety actually blossoms.For example, the following is really stunning.
Tadalafil tablets, lamivudine tablets, levofloxacin tablets, voriconazole tablets, and memantine hydrochloride tablets have not been evaluated in China. Who did you pass this?
The variety that "is about to pass the conformity assessment" is even more shocking.You can clearly tell that the current application for consistency assessment of injections, basically completely annihilated, companies have taken the initiative to withdraw.
According to our monitoring, only Puli Pharmaceutical's azithromycin for injection has passed the conformity assessment through domestic and foreign collinearity.Puli's booth is at 9.2J08, you can talk if you are interested.
These manufacturers claim that their varieties have passed the conformity assessment, mainly because of the following two reasons:
> 1, has been listed abroad, and domestic products are regarded as passing the conformity assessment.
But I can say clearly that having been listed abroad does not mean that China will certainly pass the conformity assessment.Take a look at the foreign listing area, whether it is Europe, the United States and Japan; second, see whether the same production line at home and abroad; third, see whether the domestic and foreign composition of the same process, may be completely different raw materials.
Moreover, CDE will give priority to review all those that have been declared in China and mark the collinearity at home and abroad.If it hasn't been disclosed by the CDE, forget it.
CDE has published a total of 63 domestic and foreign collinear varieties in recent years, but only 5 have been approved.Is your family really this 1/12?
2, do BE, immediately reported.
According to medical Rubik's Cube PharmaGO data monitoring, since the verification of clinical trial data in 2015, the number of BE trials applied in China has been 1996.Of these, 1042 have been completed BE, 46 have been actively suspended, and 908 are being and just completed patient recruitment.It seems that the success rate of BE is quite high, but it must be noted that completion does not mean passing, and failure is also a state of completion.I wonder, how many failures are there?
We took amlodipine as an example and counted by variety and manufacturer, 32 BE trials have been completed, but only 19 have been declared as CDE.Why aren't the other 13 varieties reported?Why?We estimate that the results of about 40% of the BE trials may not be optimistic.
So we see the step size of today's announcement, entrusted CRO to develop voriconazole for injection, willing to pay 15 million price, only to be able to package.