Research, Pharmaceutical Production License Separate From The Marketing Authorization System

Based on comparison of (MAH Marketing Authorization Holder) and (PLH production license holder) policy between develop countries and China, we take conclusion that our China can introduce MAH policy. As currently, the new drug inaugurate ability is very low, the faithfulness system still need to be established and consummated, the company and people's responsibility and morality consciousness still under improvement, so in the author's opinion,we should established our MAH policy that can accord with China's national conditions。Europen and American have built MAH policy from they foundation,with the development of regulatory and policy, they becoming perfect.this articles studied the regulatory understanding,based on this we drew a conclusion that we can set a MAH system suitable for China, and this is acceptable.Currently, our pharmaceutical industry have poor innovation ability, and process limit excellent products, on the other hand much drug permitted number are lay aside, company have overplus productivity. So we must take the currently national conditions into account if we want set MAH policy, and fish put a reasonable MAH step by step.The MAH policy that can accord with China's national conditions, that's to say set a restriction for admittance, from company aptitude to registration capital all need to take into consideration. but as research institution absorbed in scientific research, they capital investment can't equate with production company or commerce company, so MAH impact research institution bigger than company, we need to set a different specification for them. in addition, allow company combined to apply, with the contract to definitude responsibility of each other a company,research institution and commerce combond to share the profits and risks.According to our China national contidion, try MAH from certain,low risk and dosage production repeatedly,eg,tablets,capsules and orally, etc. allow the company passed GMP apply MAH first, then to the company, research consitition with GSP and registration capital stage by stage. Carry out MAH and separate marketing authorization and production authorization, this certainly will impact the toll manufacturing work, the excellent products from overseas will come to domestic for cooperation, this required the company in home must to conduct the production follow the internation standard, while our most company passed the China GMP not the cGMP, this will be a obstacle for the toll manufacturing, so government publish the related regulation and policy to help company to pass the cGMP and strength the national competition ability is needed and also good for the MAH carry out.Develop countries pharmaceutical industry were maturely, with the wholesome legal system and faithfulness,the MAH can implementation well to make sure the drug safety after its on market. But in our China currently, the research institution are deficiency in material and human resources, while drug manufacturing's dimension restrict its hardly to handle the responsibility to drug adverse events, so the MAH's respond in damages ability need to be discussed, introduce the risk control advance to make sure the safety control after drug marketed.In a word, The introduction of MAH system can promote the transfer of technological achievements, improve the R & D initiatives; also for the manufacturer, the release of commissioned production will also increased the effective utilization of its equipment, improve the concentration of the pharmaceutical industry, and thus promote China's pharmaceutical industry development.