China’s Regulatory Framework for Combination Products: Ongoing Challenges and Potential Opportunities
As the world’s second largest market for pharmaceuticals and accounting for 20% of global medical device sales with double digit annual growth, the Chinese market is poised to have a significant impact on expanding patient access to innovative therapies and combination products (CPs). 1 , 2 , 3 Following the creation of the National Medical Products Administration (NMPA) in 2018, China continues to reform and modernize its regulations. However, with the lack of global harmonization for CPs, industry needs to navigate a complex and evolving regulatory landscape in China.
- 1Chinese Medical Device Industry: How to thrive in an increasingly competitive market? https://www2.deloitte.com/cn/en/pages/life-sciences-and-healthcare/articles/chinese-medical-device-industry-whitepaper.html
- 2China’s pharmaceutical industry will be the world’s largest in under 10 years, https://daxueconsulting.com/pharmaceutical-industry-china/
- 3As AstraZeneca sounds the slowdown alarm in China, Jefferies beats the drum for growing branded drug market, Fierce Pharma, https://www.fiercepharma.com/pharma/astrazeneca-sounds-slowdown-alarm-jefferies-beats-85b-drum-chinas-branded-drug-market