The China Food and Drug Administration ("CFDA") has recently drafted the Administrative Provisions on the Examination and Approval of the Registration of Changes to Drug Production Sites (Draft for Comment) (the "Draft for Comment") for public consultation by April 19, 2018.
The Draft for Comment simplifies procedural requirements, stating that examination opinions of the food and drug regulator of the province from which a drug technology is transferred will no longer be requested, and that the transfer of new drug technologies will no longer be distinguished from that of production technologies, and that examination and approval procedures for certain circumstances, such as where varieties are transferred within the conglomerate, will be streamlined to a reasonable extent. According to the Draft for Comment, changes arising on a drug production site are considered "significant", "moderate", or "minor" depending on such changes' likely impact on ultimate products, based on previous checks over good drug manufacturing practices adopted on the drug production site, operations made on the production site and categories of drugs. Furthermore, the Draft for Comment expressly states that for narcotic drugs, Class I psychoactive drugs, and pharmaceutical precursor chemicals, it is not allowed to make changes to the drug production sites thereof for the sake of technology transfer.