1. Pink Sheet
  2. >>Geography
  3. >>Asia
  4. >>China

China Regulation in Year Of The Dragon: Good Distribution Practice, Corporate Law, Export Bans

NMPA Raises Distributor Bar

 
• By Brian Yang

A plethora of new and revised regulations in China to regulate drug distribution and storage, the set up of new corporations, administrative appeals, as well as the export of gene editing technology, are set to come into effect in 2024, ushering in more challenges to pharma and life sciences companies operating in the country.

colorful dragon
good distribution practices, corporate law among new Chinese regulations in year of the dragon • Source: Shutterstock

The year of the ox in 2023 brought many uncertainties to the pharma sector in China, but as we move to the year of the dragon in the 12-year Chinese zodiac cycle, the outlook is for multiple further changes in the country's biopharma policy and regulatory environment. 

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from China

China Approvals Rise But Conditional-To-Full Conversion Slips

 
• By Xu Hu

A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.

Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers?

 
• By Dexter Jie Yan

While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.

China Signals Commercial Insurance, Biotech And Foreign-Owned Hospitals As Policy Priorities

 
• By Xu Hu

The main 2025 policy priorities for China's government as outlined in an annual report will include the strengthening of commercial insurance for innovative drugs and opening up cell and gene therapy and the hospital sector to foreign investment.

PhRMA Kicks Off Year Attacking China, Wrapping Agenda In American Flag

 
• By Sarah Karlin-Smith

US pharma leadership is painting its mission, particularly its goal to end Medicare price controls, as patriotic and essential to America’s global dominance over China, a move that seems designed to align with President Trump’s priorities.

More from Asia

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By Vibha Ravi

Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By Lisa Takagi

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

Korea To Revise ‘Innovative Company’ Criteria Amid Calls From Foreign Industry

 
• By Jung Won Shin

South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.