Business Introduction
Regulatory Affairs

We handle the preparation of all types of registration applications for new pharmaceutical products (such as new chemical entities, biological products, and medical devices) and additional new indications. entrusted by the headquarters of Otsuka Pharmaceutical Co., Ltd. in Japan and Otsuka Group Companies. We also handle the submission of clinical trial applications for new pharmaceutical products (including those under global multi-center development), applications for post-clinical trial productions and marketing authorizations, and so on. In addition, we offer a broad range of professional consultancy services for acquiring local and foreign patents including the so-called drug Administrative Protection of various products, based on diversified strategies for the establishment and protection of intellectual property rights. Such activities are carried out in compliance with drug administration laws in China, and regulations for drug registration issued by the Chinese State Food and Drug Administration (SFDA).

Furthermore, while maintaining close communication with the SFDA,PDA,CDE,NICPBP and PIDC, the Regulatory Affairs & Intellectual Property Rights departments push ahead with our activities, putting emphasis on high quality, high speed, and low cost development.

New Drug Clinical Development

We organize and conduct clinical trials in China,Japan,South Korea and other Asian areas according tothe global development plan of Otsuka Pharmaceutical Co.,Ltd. There are two major affairs of the Clinical Development department: To perform quality multi-center international clinical trials speedily and cost-effectively that meet ICH-GCP guidelines strictly; To perform quality domestic clinical trials and various post-marketing dosage form change medication studies speedily and cost-effectively that meet China-GCP guidelines strictly;

Since its establishment in 2003, the Clinical Development department has already accomplished clinical trials for Pletaal_additional indication application and Abilify_IND application. At present, we are conducting global clinical trials and domestic registration applications in more fields, such as cardiovascular, gastrointestinal system, respiratory , neoplastic , Phymatiasis, etc.

Home About Us Business Production Join Us Contact Us Otsuka       Otsuka Beijing Research Institute