SAPA and Beijing CFDA Delegation Held Workshop Successfully on Regulatory Landscape in China and US
On December 21, 2015, Sino-American Pharmaceutical Professionals Association (SAPA) hosted an 18-person delegation from Beijing Food and Drug Administration (Beijing CFDA) at the New Jersey Commercialization Center for Innovative Technology, located in North Brunswick, NJ.
On behalf of SAPA, President Dr. Weiguo Dai warmly welcomed the Beijing CFDA delegation. He briefly introduced the history, mission and current roles of SAPA and highlighted its accomplishments since inception. Dr. Dai emphasized that exchange and training in regulatory affairs is a key goal of SAPA and this workshop helps to educate members on the much-anticipated changes in laws and regulations spearheaded by CFDA.
Mr. Jiang-Ning Li, head of the Beijing CFDA delegation, introduced the members of the group and gave an overview of Beijing CFDA's function. Following that, Dr. Wei Ji, Head of Legal Affairs at Beijing CFDA, outlined the internal structure of CFDA and its relationship with regional offices such as Beijing CFDA. He further clarified on the different responsibilities of CFDA and regional offices, and described the process of obtaining approvals for different types of products. Next, Mr. Sheng-Lin Yao, Head of Information Management at Beijing CFDA, spoke on the efforts and policies CFDA recently adopted to modernize drug administration in China. Using examples relevant to the workshop attendees, he illustrated changes that are expected to encourage innovation, simplify process, increase transparency and expedite approval of medicines in great demand. A case in point is the provisional implementation of new market approval grant rules in 10 regional offices: innovator companies without manufacturing capabilities can now hold market approval for products.
Experts from SAPA provided the workshop attendees an in-depth review of the US regulatory landscape. Dr. Xin Du elaborated on current requirements for filing for IND, NDA, and BLA, as well as for amendments and maintenance submissions. He stressed that the transition from paper filing to electronic filing is imminent and companies should be prepared to make that transition in the near future. Dr. Lee Kang spoke about the current GMP and GLP practices, in particular, the importance of quality metrics and data integrity. He pointed out that FDA is actively executing new strategies to monitor industry GxP. For example, FDA inspectors are now able to issue Warning Letters without resorting to Form 483 (Inspectional Observations) first. Following the Warning Letter, the inspected companies will only have 15 days to respond.
After a short coffee break, all attendees reconvened to participate in a lively Q&A discussion. Questions from the audience are diverse, with many of them focused on how the proposed new changes in laws and regulations by CFDA will affect applications in China, especially by foreign companies. Members of the Beijing Delegation and SAPA experts addressed these questions in detail and agreed to forward feedback to CFDA.
At the end of the workshop, Dr. Jiwen Chen, Immediate Past President of SAPA, thanked the delegation for making time in their schedule to attend the workshop. Leaders of both groups agreed that this workshop marks the first step in exchange of regulatory expertise and information between SAPA and Beijing CFDA, and the two groups will strive for further collaboration in the future.