China’s SFDA has issued new guidelines that will make pharmaceutical manufacturers more accountable for the quality of excipients. The SFDA defines excipients as substances that are used to supplement and/or bind the prescribed contents of a drug. Drug manufacturers will be asked to take greater responsibility of the audit and management of the companies from which they purchase excipients.
A risk-based monitoring system will be introduced for excipients. The SFDA will assess higher-risk excipients and the factories that produce them with stricter criteria before approval. In addition, excipients being used for the first time will be assessed together with the prescribed drug contents. Drug manufacturers will be asked to verify the origins of the new excipients. Manufacturers will also need to ensure that the quality of the new excipients complies with all technical requirements.
These guidelines do not provide further details on what the “stricter criteria” will entail, how the new regulations will be enforced, or how violators will be punished. These guidelines come several months after plans were proposed by the Chinese Pharmacopeia Committee to increase the number of excipients listed in the Chinese Pharmacopoeia from 130 to 381 in three years. The new regulations are scheduled to come into effect in the fall of 2012.