The State Council of the PRC released the General Opinions on Adjusting the Essential Medicine System (“Opinions”) on 19 September 2018.

Compared to the current system for essential medicines, the main changes include:

  • The National Essential Medicine List should be updated regularly (about every three years). The authority will add or remove medicines based on the efficacy, safety, cost-effectiveness, adverse drug reaction and other relevant criteria.
  • The manufacturer should be primarily responsible for the supply of its essential medicines. In the event of medicine shortages caused by the manufacturer, it should assume liabilities for breach of contract. In addition, the authority will list that manufacturer onto the dishonesty record.
  • The punishment for the abuse of a dominant position and monopoly agreements in the market of essential medicines will be more severe.
  • For generic drugs, the authority will prioritise the review of applications relating to the addition of new medicines that have passed the Quality and Efficacy Evaluation1.

To read the full text of the Opinions (in Chinese only), please click here.