2016 saw important developments for the Lifesciences sector in China, including:
- The launch of anti-trust investigations by the National Development and Reform Commission (the ‘NDRC’) into the pharmaceutical and medical device sectors and the issuing of significant fines.
- Implementation of new policies and procedures by the China Food and Drug Administration (the ‘CFDA’), including the food and drug traceability system, Approval Process for Medical Devices and Pilot Drug Marketing Authorisation Holder (‘MAH’) system.
- Confirmation by the CFDA on the completion of the legal framework for food and drug regulation by 2020.
In this update, we have collated the significant ‘China Lifesciences Monthly Updates’ for 2016 and set out our top 10 predictions for 2017.
In 2017, we expect developments on the anti-trust investigations, tightened supervision on anti-bribery, the new drug price regime, details on the implementation measures on the registration of biosimilars, the reform in social insurance, M-health and medical industry.
We will continue to closely monitor the developments in the Lifesciences sector in China and to provide you with regular updates on them through our free eAlert service, Law-Now.