"One-off import of control drugs" arouses heated discussion that pharmaceutical enterprises are constantly complaining or facing many problems
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Last Update: 2016-03-11
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Source: Internet
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Author: User
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Recently, CFDA issued a notice (Draft for comments) on the one-time import of reference drugs needed in the process of drug development, which caused a great stir in the pharmaceutical industry, with one-sided doubts and objections The announcement reads as follows: for the drugs that have been listed outside China but have not yet been approved for listing in China, and need to be used in the domestic drug registration research or the generic drug quality and efficacy consistency evaluation research, a one-time import application must be submitted In addition, the drug specification, quality standard and delivery inspection standard must be provided As a large imitation country, category 2 and Category 3 drugs have always been the top priority of R & D the General Administration of China has issued a major policy that is not grounded, which really makes Chinese pharmaceutical enterprises difficult If this policy is implemented, I don't know how many domestic drugs will not be born, and how many pharmaceutical enterprises will be severely damaged or destroyed Why is a policy less than hundreds of words stormy for the pharmaceutical industry? Why? One: where to find the quality standard of the original research drug? The original manufacturers will not be confused to hope who will copy their own drugs and cultivate competitors to seize the future market This means that it is impossible to carry out in vivo be and phase III clinical trials without quality standards What else can we do for class 2 and class 3 drugs? Second, the announcement clearly stipulates that the imported reference drugs can only be used for the specific purposes specified in the application document for approval of imported drugs, and should meet the requirements of relevant laws and regulations For non clinical pharmaceutical research, it is also necessary to apply for one-time import Many pharmaceutical researchers have to worry about losing their hair Third: in vivo be experiment must be done, application is troublesome For pharmaceutical enterprises, the amount of be needed in the body is relatively small, and they have to write one-time import applications The endless difficulties and troubles make many pharmaceutical enterprises flinch Nowadays, the country has implemented the be filing system to shorten the examination and approval time Now it is necessary to write an import application and conduct port inspection What is the significance of the so-called be filing system? If we don't talk about the import time limit of "approval document for imported drugs" within six months, these items will be enough for many pharmaceutical enterprises to suffer If the policy is implemented, the fate of small and medium-sized pharmaceutical enterprises will be worrying It is not easy for top pharmaceutical enterprises to survive.
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