Research On The Development Of Medical Outsourcing On The Basis Of Drug Registration System Reform In China And The Practice Of API Registration Abroad

With the increasing cost of drug development,production and sales,the medical outsourcing enterprises have emerged,which can effectively reduce the R&D risk and cost of production and sales of pharmaceutical enterprises.As an economic cooperation model between pharmaceutical enterprises,medical outsourcing plays an important role in drug development,manufacturing and sales.At the same time,medical outsourcing,as a pharmaceutical relevant industry,is regulated and restrained by corresponding drug laws and regulations.The medical outsourcing in China is still at the initial stage of development,and China's regulations on medical outsourcing are not yet sound.Now the drug registration system of China is going into a new round of reform,this article starts from the development situation and supervision requirement of Contract research organization(CRO)and Contract manufacture organization(CMO),compares the relevant supervision regulations between China and Europe,America and other developed countries,evaluats the reform status and impacts on four aspects of China drug registration system such as encouraging innovation drug development,improving the standards of drug reviewing,quality management on the beginning of drug life cycle and and marketing authorization holder system,and discusses the development influences and suggestions for medical outsourcing.Medical outsourcing exists in various stages of drug life cycle,such as drug development,registration,production and marketing.Medical outsourcing,as a form of cooperation between pharmaceutical companies and other pharmaceutical R&D and manufacturers,actually is a mode of business operation between enterprises.For CRO in China there is no specific rules and regulations,the Drug Administration Law,Drug Administration Law Implementation Regulations,Drug Registration Management,GLP(Good laboratory practice),GCP(Good Clinical practice)and other laws have universal applicability.Comparing the MAH of European and American with the relevant laws and regulations of China,it is not hard to find the differences mainly in the marketing system,the subject and form,product scope and responsibility,etc.On the backdrop of the industrial structure adjustment of China,first of all,the increase of innovation drug and generics consistency evaluation will promote the rapid growth of medical outsourcing,the cooperation way changing,and the emergence of new business growth point;with the development and production of innovation drug,China's medical outsourcing pattern will move up the topper of value chain,and the scope will extend to the entire drug life cycle;Comprehensive outsourcing enterprises with core competitiveness keeps ahead in the business negotiation to get more opportunities of strategic cooperation with large patent medicine company,and share the innovation drug benefits.But especially for the domestic pharmaceutical enterprises which are willing to develop medical outsourcing,subsequent supporting system and international regulations might be a big block,pharmaceutical companies and local authorities should actively change ideas,develop advantages,implement and increase of the policy support,promote their strength and regulatory level,and make a smooth transition.Finally,the author summarize the abroad registration work experience of APIs and intermediates in European Union and FDA,for example,registration system,dossier requirements,the registration service and etc.It is expected to provide experience and reference for domestic pharmaceutical enterprises to carry out outsourcing business abroad.