In September, China’s State Food and Drug Administration issued a draft of its revised Good Manufacturing Practices for drugs. The public will have until the end of November to make comments. The last GMP standards came into effect in 1999. The new GMP adds an appendix for blood products and expands the appendix addressing sterile drug products. Areas of focus include drug quality control systems and documentation. Among the new concepts are quality risk management, product-quality retrospective analysis and continuous stability studies. The new standards are expected to take effect early in 2010 and to allow a grace period for compliance.

Source: Sidley Austin