The Chinese government's establishment of a single drug regulatory authority in 2003 (China Food and Drug Administration) was an important step toward foreign access, because it eliminated the conflicting standards that prevailed among provincial government agencies, centralized the Chinese healthcare regulatory system, and made it more transparent to industry partners.
The CFDA now oversees all medications. Other former functions of the ministry have been assigned to different government bodies. The most important of these was the transfer of medical insurance responsibilities to the new Ministry of Labor and Social Security. The Ministry of Health retains its other main functions: regulatory development and oversight, healthcare resource allocation, and medical research and education.
In 2010, China amended GMP, GLP, GCP, GSP and other regulations with an aim to further align the country with international standards of practice. For manufacturers and distributors and importers of drugs and medical devices in China, it is imperative to pay close attention to the pace at which CFDA implements these changes. They have to make changes accordingly to their standard operating procedures, so that they can ensure compliance quickly and effectively with the evolving regime.
China [CFDA] continues to make Regulatory Requirement Changes at a fast pace. Just in the last couple of years alone, changes have been proposed and implemented in Drug & Biologics Licensing, Medical Device Registrations and have been proposed for Dietary Supplements approved by CFDA. This 90-minute webinar will update you with all of these changes.
China has been improving its regulatory regime governing the food and pharmaceutical industry in recent years. For manufacturers and distributors of drugs and medical devices in China, it is important to pay close attention to the pace at which CFDA implements these changes and makes additional changes to their operating procedures.
This webinar with expert speaker Robert J. Russell will specifically focus on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in China. The session will also include descriptions of the methods by which regulators in the CFDA process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Who Should Attend:
- Dr. David Lim
Robert Russell, holds a B.S. and M.S.in Chemistry. Prior to founding RJR Consulting, Inc., a Global Regulatory Consulting firm in 2001, Mr. Russell spent 28 years in the Pharmaceutical and Medical Device Industry with two Fortune 150 firms working in CMC, Global Business Development and Regulatory Affairs.