Chapter 8 - Chinese Regulatory Framework

Abstract

This chapter describes the Chinese Regulatory Framework involving Drug Administration in China and registration. China has established a very streamlined drug regulatory system from a nearly zero base during the past 30 years, along with its national policy of reform and opening up. The State Food and Drug Administration (SFDA) and its affiliates play a key role in this system. In 2003, the SFDA was established to replace the State Drug Administration (SDA), with expanded functions. The SFDA was modeled after the US Food and Drug Administration (FDA), and operates under supervision of the Ministry of Health. In Drug Registration Regulation SFDA, a drug should fall into one of three categories: small molecule, biological product, or traditional Chinese medicine. Though diffeerent types of CTA provide different ways to conduct clinical trials in China, for any sponsor, the ultimate goal is to receive marketing authorization. Because of the long regulatory process and duration, it leads to a long registration lag compared with other countries. The greatest incentive for these opportunities is the enormous potential for cost savings in clinical study, and a large population pool, which translates into faster enrollment. The Chinese SFDA does not currently engage in a simultaneous IND submission process, so for applicants who are seeking a shortcut within the existing regulations to reduce the registration lag, the only way is to add China to their global development and start CTA under a different name as soon as possible after the overseas clinical program enters global markets.