Updated on 26 September 2012
Are regulatory hurdles in China as massive as its Great Wall?
The domain of biosciences in the Asia Pacific (APAC) region offers several opportunities for companies that are looking for growth in the region. Regulatory approvals are, however, a challenge for these firms in the APAC region. BioSpectrum speaks to industry insiders and regulatory professionals from China, in order to compile a guide on the regulatory processes in the dragon nation. (Also read throughout this week: Regulatory requirements in Taiwan, Australia, Hong Kong, India, Indonesia, Singapore and Korea)
In China, drug and biological products are regulated by the SFDA, which is a counterpart of the US FDA. The Center for Drug Evaluation regulates both drug and biological products in the country.
Marketing authorization of a new drug in China mandates clinical trials with Chinese patients as prerequisite. The applicant has to conduct phase I pharmacokinetic studies together with randomized clinical trial with at least 100 pairs of subjects. Clinical trial application review and approval takes approximately 12 months.
Drug import approval requires availability of marketing authorization outside China, such as certificate of pharmaceutical product from a reference country. Multi-region clinical trials can be started only after the new chemical entity has been tested in phase II outside of China. This prevents China from participating in simultaneous global drug development.
Drug approval in China follows first international new drug application approval. There are two drug registration pathways in China which include new drug application and import drug license. Similarly, there are two clinical development strategies. They are sequential development and parallel development.