Updated on 25 April 2012
After five years of amendments and two rounds of public consultations, the State Food and Drug Administration (SFDA) issued Good Manufacturing Practice for Drugs that came into effect on March 1, 2011. As per the guideline, the newly built drug manufacturers and the newly built (reconstructed or extended) workshops of drug manufacturers shall comply with the requirements of the new version of GMP.
Improving the situation of existing facilities, the SFDA has instructed that the existing drug manufacturers will be granted a transition period of not more than five years to meet stage-by-stage the new version of GMP in accordance with the product risk level.
In 2011, WHO did an assessment and declared that China is complying with international standards for biologics regulation.
Stringent steps taken by the SFDA indicate that China has dramatically changed its regulatory environment and the manufacturing facilities have to go through much stricter laws.
Commenting on the changing landscape of China, Dr Wu Ke from Shanghai BravoBio, says, "The new version of GMP is effective, which is quite close to European cGMP and also the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines in most aspects. With the development and globalization of the Asian economy, more and more countries will upgrade their regulatory system adapting to the demands of new technology and higher standards."