The International Registration Of Active Pharmaceutical Ingredient Levodopa

Before an API is exported abroad, the market authorization must be granted. The API International Registration is an exclusive approach obtaining market authorization, it includes the following three registration procedures:preparing related documents according to the requirements of API importing country, submitting application and obtaining market authorization.At present, the production of APIs in Chinese pharmaceutical industry is still at a relatively low level comparing with advanced international pharmaceutical enterprises both in GMP management and in API registration. Meanwhile, there haven’t been official regulations for guiding international registration so far in China. Therefore the compliant DMF and the production quality management system are the factors which decide whether the pharmaceutical enterprises can enter the overseas market.In this paper, the author takes levodopa as an example to discuss the API international registration procedure in depth, focusing on the DMF preparation procedure, issues need to pay attention to and solutions during the site inspection, anticipating that it can provide certain references for the production enterprises of APIs in China.Firstly, the definition of API and registration procedure in FDA and EDQM are introduced. Top ten deficiencies occurred during the international registration are summarized according to the current situation of the international registration of APIs in China. Secondly, the contents and format of DMF, and the guidance documents issued by ICH are introduced. The issues need to pay attention to during the preparation of DMF and solutions are given combining with the author’s working experience. The registration application procedure of DMF and attentions during the response to the additional information for DMF requested by authorities are summarized. Thirdly, the issues need to pay attention to and solutions during the site inspection together with the site inspection of levodopa are described in details. Finally, an overview is given in the paper.The API international registration is the first step that the APIs of production enterprises in China enter into the markets of other countries or regions. The APIs can be sold to the country only after the registration in the country is completed. This paper describes in details the registration procedures in EDQM and FDA taking levodopa as a successful example and put forward some suggestions applicable for the API manufactures in China, and summarize some attentions according to the experience of the author, which will be helpful for domestic API manufactures in saving the international registration time, avoiding detours, speeding up to enter the markets in Europe and the United States and increasing the share of Chinese APIs in the international market. More importantly, this will further promote the upgrade of the industrial structure of APIs in China and improve GMP management level.