Fairy fight, enterprise suffered domestic generic drugs in the future has a long way to go

2018-12-27, the Website of the National Pharmacopoeia Commission publishes "Letters on Matters Related to the Quality Standards of Amoxilin Capsules". As it is sent to the Drug Review Center (CDE), copied to North China Pharmaceuticals, this letter by some self-media interpretation of some public taste, so caused a lot of concern and discussion with colleagues.
on this matter, deconstructed as follows: the variety of "Chinese Pharmacopoeia" all specifications (0.125g, 0.25g and 0.5g specifications) solubility inspection is proposed as: basket method / 100 turn, water medium 900ml, 45min, 80% limit.
The American Pharmacopoeia is: (Method I) water medium 900ml, 60min, 80% limit, but the device and speed vary according to specifications: 0.125g using basket / 100 l, 0.5g using paddle / 75 l. (Method 2) Basket method / 100 turn, water medium 900ml, 90min, 80% limit. It is clear that since both the original drug and the U.S.-listed generic drugs are slow to release, the conditions are more relaxed than the Chinese Pharmacopeia.
At the same time, the same is true of products listed in Japan, as can be seen from the published "Four Dissolved Curves of The Comparing Agents" and the quality standards established: paddle method/100 l (plus semoulation basket), water medium 900ml, 60min, 80% limit (125mg specification) and 75% limit (250mg specification).
, the history of generic drug development in China was well known. For this variety, are made in a hurry than the original drug dissolved faster imitation agent, but because the biological ethonthorism (BE) test has no latent rules, CDE all approved.
When the variety was included in the Chinese Pharmacopeia, strict test conditions were adopted because the Pharma Commission's principle of quality standards was "not to consider the dissolution of the original drug, based only on the dissolution of domestic generic drugs approved for listing by CDE", As a result, the original drug according to the "Chinese Pharmacopoeia" test is not qualified, good in the not imported, otherwise foreign enterprises will be a fog (this is by no means an isolated case, similar cases also please look at the extension of reading-1, this is the origin of individual laughable non-quality standards).
Today, North China Pharmaceuticals conducts generic consistency evaluation, according to the CFDA designated evaluation of the preparation (0.25g and 0.5g for the European Union listing, 0.125g for the Japanese market), after the second development of the product is no refore in line with the Chinese Pharmacopoeia, so to the CDE declaration and to the Pharmacopoeia Commission to amend the Chinese Pharmacopeia.
Results, CDE opinion is "because the declared quality standards do not meet the Chinese Pharmacopeia, it can not be approved, because the Drug Administration Law stipulates that products listed in China must comply with the Chinese Pharmacopeia," so enterprises are invited to communicate with the Pharmacopeia Commission first...";
In the eyes of the outside world, this is obviously the two institutions throwing pots at each other, pushing and shoving behavior, and must have occurred many times, this pharmacopeia commission only publicly called CDE, really can be described as "the fairy fight, the enterprise suffered." In charge of the review of the CDE and standard-set pharmacopeia committee, you as the country's two core technical departments, but the responsibility is great, determine the life and death of the enterprise ah! We sincerely hope that both sides can sincerely cooperate and work together in the same boat, and then join hands with our enterprises to create the future of generic drugs in China. (dandelion)