In order to implement the requirements of “carrying out skills training around professional inspector team construction” of leading Party group of the CFDA, to promote the capacity of inspectorate, and improve the professional skills and comprehensive quality of the inspectors, the Third Experts’ Forum of CFDI was held successfully according to the work plan of CFDI Academic Committee on April, 28 , 2017. Dr. Zhang Guohua, the president and CEO of Nantong Lianya Pharmaceutical Co. Ltd. was invited in this expert forum, and made the lecture entitled “changes of US FDA regulatory system and the requirements to the development of generic drugs Research & Development production”.
Dr. Zhang has 28 years of experience in pharmaceutical research and development, involved in the development of over 160 species generic drugs and new drug preparation products, he has rich practical experience in the development of drug conduction system and sustained-release preparations. His lecture includes four aspects, one is to introduce the US FDA's technical requirements and documentation requirements for generic drugs; the second is the introduction of how to carry out generic drug prescription and production process research by using the principle of Quality by Design (QbD) and the Science and Risk Based Approach (SRbA) combined with examples; thirdly, it is the introduction of the requirements of FDA for the design and implementation of bioequivalence research. Fourth is the introduction of FDA’s inspection methods, key content and main problems founded about cGMP combined with this enterprise’s experience of receiving FDA’s inspection. His lecture is both comprehensive and focused, there are both the explanation of laws & regulations and sharing of experiences, which has a high guiding value to the participants who are engaged in the relevant inspection work.
Nearly 280 people of CFDI, the Chinese Pharmacopoeia Commission, Beijing Drug Certification Management Center and 13 provincial drug inspectorate from the whole country synchronously watching through video system participated in the training.
