Princeton, NJ, March 29, 2016 --(PR.com
)-- Sino-American Pharmaceutical Professionals Association (SAPA) organized a workshop entitled “China CFDA and US FDA Regulation on Botanical/Chinese Medicines” at DoubleTree Conference Center located in Somerset, NJ. With the generous support of Shimadzu China Corporation, SAPA invited several prominent speakers to present at this workshop: Mr. Hongyu Jin from China Food and Drug Administration (CFDA), Dr. Jinhui Dou from US Food and Drug Administration (FDA), and Mr. Andrew Jiang - CEO of Aleon Pharma International. The workshop was hosted by regulatory affairs expert Dr. Xin Du and attracted nearly 100 attendees.
SAPA President-Elect Dr. Lei Tang welcomed all speakers and guests, especially the CFDA delegation that traveled from China to attend this event. She briefly introduced the history, mission, membership and activities of SAPA. Dr. Tang pointed out that this workshop marks the first event organized by the new SAPA Regulatory Affairs Committee headed by Dr. Du.
The major focus of this workshop is the current trends of Botanical/Chinese Medicines and the regulatory affairs associated with these products in both China and US. Mr. Hongyu Jin is Associate Director at the Institue for Control of Chinese Traditional Medicine Ethnic Medicine., a branch of CFDA National Institutes for Food and Drug Control (NIFDC). On behalf of Head of ICCTMEM - Dr. Shuangcheng Ma, Mr. Jin presented a comprehensive overview of the current Botanical/Chinese Medicine market in China and elaborated on the laws and regulatory guidance for managing this market. Using common medicines as examples, he illustrated how different medicinal products are regulated in China. Furthermore, Mr. Jin described the organizational structure of CFDA and the main function of various units of CFDA.
Dr. Jinhui Dou has extensive experience in drug research and development. He was also directly involved in the review process of the 2 Botanical Medicines approved by FDA in the last 10 years. Dr. Dou compared the different regulatory pathways for Botanical Drugs and Dietary Supplements. Drawing from his own experience, he illustrated the many unique challenges developers of Botanical Medicines face and shared many practical suggestions. At the end, Dr. Dou encouraged scientists and companies to follow the footsteps of recent Nobel Laureate Dr. Tu You You to utilize the rich botanical resources and discover novel new drugs to meet unmet medical needs.
After a short coffee break, Mr. Hongyu Jin from CFDA returned to the lectern to deliver a speech on quality control of Botanical/Chinese Medicines and other main functions of the ICCTMEM. He described the innovative measures he and his team applied to common medicines to improve quality control and lower test costs. Mr. Jin also presented the wide variety of major international collaborative efforts ICCTMEM spearheaded.
Last presenter of the workshop is Mr. Andrew Jiang from Aleon International Pharma, a company specialized in aiding pharmaceutical companies in drug development. Mr. Jiang delineated the drug development process in US with a special focus on the requirements and considerations for Botanical Medicines. Mr. Jiang used a case study of Veregen (a FDA approved Botanical Medicine derived from green tea leaves) to demonstrate that FDA can be flexible in the review process if a product addresses an unmet medical need.
During the hour-long Q&A session following the speeches, attendees both onsite and online had a chance to have their questions answered. The topics of discussion range from optimal regulatory pathway for Botanical/Chinese Medicines, methods of improving quality control, to ways to introduce Chinese Medicines to the rest of world. At the end of the workshop, speakers from CFDA and FDA thanked SAPA for providing an excellent platform for open exchange of information and insights on key regulatory issues.