Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
ElendiLabs
Hong Kong
ElendiLabs specializes in medical device regulatory affairs in Hong Kong, providing comprehensive support for MDACS registration and compliance.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
December 15, 2025
Approximately 5 minutes
China's Dual Drug Pricing System: CDR Registration to Support Global Expansion
China's Dual Drug Pricing System: CDR Registration to Support Global Expansion
China is implementing a transformative approach to pharmaceutical pricing with the introduction of the China Drug Registry (CDR). This database serves as a formal record of transaction prices occurring outside the public health insurance system, specifically in private hospitals, online platforms, retail pharmacies, and high-end medical institutions.
The Mechanism of the CDR
Unlike the heavily regulated provincial procurement platforms, the CDR operates on a self-reporting model:
- Authenticity: Manufacturers report their own prices, backed by a commitment letter confirming data accuracy.
- Verification: A state-owned operating unit conducts formal verification without interfering with the reported price level.
- Flexibility: Companies can apply to adjust prices based on clinical value, supply-demand dynamics, or competitive changes.
Overcoming International Reference Pricing (IRP) Challenges
The primary strategic goal of the CDR is to mitigate the impact of International Reference Pricing (IRP), where countries look at a drug's price in its home market to set their own limits.
- For Chinese Innovators: Companies seeking to launch in markets like Brazil have previously struggled because Brazilian regulators referenced low Chinese public insurance prices. The CDR provides authoritative proof of higher private-sector prices, facilitating fair market entry abroad.
- For Multinationals: Global firms can register private-market prices in China without fearing that these will be dragged down by public reimbursement rates, protecting their global price floors.
- Multilingual Certification: The registry provides multilingual certificates, allowing these prices to be officially recognized by international regulatory and procurement bodies.
A Broader Strategy for Innovation
The CDR is part of a larger wave of reforms aimed at making China a premier global hub for pharmaceutical innovation:
- China-ASEAN Procurement: Facilitating the entry of Chinese medicines into Southeast Asian markets.
- Confidentiality: Adoption of voluntary confidentiality pricing for the National Reimbursement Drug List (NRDL) and stricter rules for innovative drugs in commercial insurance.
- Supportive Measures: Implementation of 16 government measures to boost R&D, medical insurance access, and commercial insurance integration.
By separating public reimbursement from private market value, the National Healthcare Security Administration (NHSA) is providing a standardized and transparent platform that encourages both the globalization of Chinese medicine and the launch of new foreign drugs within China.