Overall Considerations On Microbial Drug Registration In China And Outside Of China

Microbial drugs are widely used in the treatment for the disease areas of infection,tumor,immune etc.,and play very important role.Due to the wide range of sources and many kinds of microbial drugs,complex manufacturing process and not controlled easily,big difference in registration requirements between microbial drug and chemical synthesis product.But there is no related guideline issued by China health authority for technical requirements in microbial drug registration.Therefore,the study on registration requirement and related regulation in China and outside of China for microbial drugs have great significance.This study is aiming at combing and analyzing the registration requirements of microbial drugs released by China,US and Europe comprehensively and systematically.It can provide good reference for the research,development,manufacturing,and registration work of microbial drug.The study results for microbial drug project are as below.1.Different definitions of biological product and corresponding classifications in each country cause the difference in the registration category of microbial drugs.Given the definitions of Biological Product in China and US are different,when classify microbial drug into chemical drug or biological product for registration,mainly consider if manufacturing method is biological technology,number of amino acid and also if final product obtained is chemical substance(single or multiple active substances).2.For fermentation or semi-synthesis product,drug registration requirements on manufacturing process and process control in China and outside of China are basically same,especially strict requirements on source and identification of strain,fermentation process,control condition,extraction process.In addition,impurity control strategy for fermentation and semi-synthesis product are different from it for chemical synthesis product.European Medicines Agency(EMA)"Antibiotics Related Impurity Specification Setting Guideline" is good reference.3.US and EU published a series of encouraging policies for research and development of new antibiotics,which cover communication between healthy authority and industry,scientific advice,accelerated approval,exclusivity period,guidelines related to antibiotics during research and development.Currently lack of encouraging policy for antibiotics in China,suggest to take actinons like US and EU,to encourage and guide the research and development of antibiotics with urgent clinical needs.4.US Drug Master File(DMF)system is similar to Active Pharmaceutical Ingredient(API)bundling review system in China.API will not have the separated approval number,but combined review and approval with drug product(except for generic API),which bring new opportunity and challenge to API manufacturer.