Draft Amendments of Chinese Pharmaceutical Administration Law Open to Public Consultation until 1 December 2018

The Draft Amendments of the Pharmaceutical Administration Law of China have recently been deliberated at the 6th session of the Standing Committee of the 13th National People's Congress (NPC), and are now open to public consultation, the deadline of which is 1 December 2018.

 

These draft amendments focus on strengthening the national drug supervision mechanism by a number of measures, including: requesting the drug marketing license holders, drug manufacturers, and medical institutions to practice strict drug tracing procedures; holding individuals such as drug marketing license holders and legal representatives of drug manufacturers responsible in terms of quality of drugs and legal compliance of production and operational activities; imposing heavier administrative penalties on acts of violations; and nationwide implementation of the pilot drug marketing licensee system, with incorporation of certain legal obligations of license holders and additional licensing requirements.

 

Members of the public may voice their opinions on the draft amendments via the NPC website at www.npc.gov.cn, or by direct mail to Legislative Affairs Commission of NPC before the expiration of the consultation period.