In the first half of 2025, China’s healthcare and life sciences regulatory framework underwent a wave of important reforms. These developments reflect the country’s continued efforts toward global alignment, innovation, and regulatory transparency. For multinational pharmaceutical, medical device, and healthcare companies operating in or entering the China market, these reforms present both opportunities and new compliance requirements.
This GT Advisory summarizes four significant developments:
1. | New NMPA policy optimizing localized production of imported medical devices |
2. | Draft Measures to strengthen clinical trial data exclusivity protection |
3. | Finalized anti-corruption compliance guidelines for the healthcare industry |
4. | Anti-monopoly guidelines specifically targeting the pharmaceutical sector |