The Department of General Affairs of the National Medical Products Administration ("NMPA") has recently issued the Interim Provisions on the Administration of Domestic Agents of Overseas Drug Marketing Authorization Holders (for Trial Implementation) (Draft for Comment) (the "Draft for Comment") for public comment by August 21, 2020.
The Draft for Comment provides that an agent shall meet four conditions, including "being a corporate legal person established within the territory of China", and fulfill eight obligations, including "being responsible for establishing a drug quality assurance system to ensure that it continuously has quality assurance and risk control capabilities". The Draft for Comment further clarifies that an overseas holder shall file its agent for the record with the provincial medical products administration of the place where its agent is registered within 30 working days as of the date when agency is granted to the agent. An overseas holder that applies to a medical products administration for a Customs Clearance Form for Imported Drugs and an Import Permit shall produce a certification document regarding an agent that has been filed for the record. If such document cannot be produced, the medical products administration shall order the overseas holder to make correction within a time limit; if the overseas holder fails to do so within the time limit, no Customs Clearance Form for Imported Drugs or Import Permit may be issued.