9 Jan 2020
China’s Revised Drug Administration Law Comes into Force
Drug Marketing Authorisation Holders are now accountable for the safety and effectiveness of drugs.
This follows the revised Drug Administration Law of the People’s Republic of China, adopted at the 12th session of the 13th NPC Standing Committee on 26 August 2019, which came into force on 1 December 2019. In a statement on the implementation of this revised law (Announcement No. 103 ), the National Medical Products Administration announced that the Drug Marketing Authorisation Holder system will be fully implemented.
Since 1 December 2019, enterprises or drug R&D institutions holding drug registration certificates (Registered Number of Drug Approval, Imported Drug Registration Certificate or Pharmaceutical Product Registration Certificate) have been required to strictly discharge their obligations as Drug Marketing Authorisation Holders. Such Holders are accountable for the safety, efficacy and quality of the drug in question during the full cycle of its development, manufacturing, distribution and use in accordance with law.
Source: National Medical Products Administration