In an executive meeting on 20 June 2018, the State Council of the People’s Republic of China (“State Council”) announced several favourable policies for the drug industry, including accelerating the registration process for new drugs which have been marketed overseas, decreasing anti-cancer drug prices and ensuring the supply of drugs.
Key points of the policies have been summarised below:
- Accelerating the registration process of new overseas marketed drugs
- The marketing registration requirements for orphan drugs and certain drugs for preventing and treating severe life-threatening diseases will be simplified. All research materials obtained abroad can be submitted for market authorisation. The authority should make their decision within 3 months for orphan drug applications and within 6 months for applications for drugs for preventing and treating severe life-threatening diseases.
- For the import of chemical drugs, pre-registration verification will change to the supervision of post-marketing sampling, and this sampling will not be a condition for the inspection of imports.
- Taking measures to reduce anti-cancer drug prices
- Local governments should apply a specific bidding and procurement regime for anti-cancer drugs that are listed in the National Drug Catalogue for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2017 Edition) (“Catalogue”).
- For anti-cancer drugs not listed in the Catalogue, there will be an acceleration of the negotiation process to add those drugs into the Catalogue.
- There will be a pilot of a national drug collective procurement regime, which aims to significantly reduce drug prices.
- Strengthening the monitoring and early warning systems of the of drugs in short supply
- A recording system will be established to list manufacturers who have ceased to make drugs in short supply and their corresponding Active Pharmaceutical Ingredients. The aim is to increase the storage of these drugs to ensure their accessibility for patients.
Although the practical details of the policies are yet to be seen, these favourable policies indicate a lot of commercial opportunities and benefit for both domestic and overseas pharmaceutical enterprises.
To read the full text of State Council’s announcement, please click here.