The Chinese State Food and Drug Administration announced a reform plan concerning regulations. The SFDA is asking for public comments concerning the plan.
The key strategic priorities expressed in the plan are:
- The will to accelerate technical reviews and regulatory approvals for innovative drugs. For this the SFDA has proposed to reward drug R&D capable of delivering better therapeutic effects on critical diseases. The reward results in indigenous intellectual property by accelerated technical reviews and regulatory approvals for the resulting innovative drugs. Moreover, innovative drugs whose R&D is sponsored by the Chinese government will be treated with high priority in technical reviews. Pre-clinical studies for innovative drugs were also mentioned, stating they should be risk-based ant that their technical evaluation should aim for a higher level of control of the quality risks. The SFDA might outsource pre-clinical studies’ technical review. They will also consider allowing the transfer of clinical trial authorizations.
- Technical reviews and regulatory approvals for high priority generics are also to be accelerated. In fact, the SFDA is going to define an evaluation mechanism for marketed generic drugs. “Generic drugs which fail to demonstrate sufficient clinical values will be discouraged from further development and manufacturing”. Generics which have a shortage in supply, insufficient competition, limited patient access and affordability, an indication for pediatric, rare or special diseases and have been evaluated as urgently required for clinical use will therefor receive high priority in technical reviews and regulatory approvals. “The quality consistency evaluation for generics will be a major policy initiative in the next couple of years and will lead to the formation of a Chinese Orange Book.” According to Mondaq.
- Clinical studies’ quality control will be improved “SFDA will establish an information disclosure mechanism to enhance transparency of clinical studies and raise public awareness of the notion of, and need for, clinical studies.”
- To boost development and manufacturing of pediatric drugs.
Source : www.mondaq.com Publication Date : 2013-01-14