To promote virtuous development of the pharmaceutical industry and regulate variety transfer between companies, CFDA has successively published the CFDA Notice on Matters Related to Pharmaceutical Technology Transfer in the Process of Implementing the Newly Revised Management Standard for Pharmaceutical Production Quality and the CFDA General Office Notice on Requirements Related to Pharmaceutical Technology Transfer in the Process of Implementing the Newly Revised Management Standard for Pharmaceutical Production Quality. Under the regulation with the two notices, some provincial administrations are responsible for transfer appraisal of drug approval documents during this special historic stage (transitional period of implementing the new version of GMP).
As the situation of technical forces varies among different provincial administrations, CFDA conducts technical assessment on each provincial administration. Upon assessment, provincial appraisal power has been given to Shandong, Shanghai, Jiangsu, Guangdong, Zhejiang and Beijing by priority.
With continuous adjustment and reestablishment of regulatory model, it is estimated that other technical appraisal powers will be delegated to provincial administrations.
