Drug registration in China has become increasingly important as the country’s pharmaceutical drug market continues to grow. China is now the second-largest pharmaceutical industry in the world, after the United States. It is estimated to reach USD 161.8 billion by 2023, with an average growth rate of 5% in the coming years, accounting for nearly 30% of the global market.
Moreover, the acceleration of new drug access, evolving regulatory requirements across different product categories, and the rapidly aging Chinese population have significantly increased overall medical demand. As a result, these changes create substantial opportunities for pharmaceutical companies.
After more than 13 years of regulatory development, the Chinese regulatory system has introduced multiple updates to existing rules and guidelines. These updates are intended to reduce procedural complexity and align more closely with global regulatory standards.
Highlights of China’s new provisions and opportunities
Let’s look at some key highlights introduced by Chinese regulators:
– A 60-day timeframe for CTA approval, aligned with global regulatory practices
– Clearly defined timelines for review and approval across different application types
– Streamlined coordination between the registration process and manufacturing authorization to ensure GMP compliance
– Improved communication between applicants and the Center for Drug Evaluation (CDE) to support a more efficient CTA process
– Parallel, risk-based site inspections and laboratory testing conducted alongside technical review
– Breakthrough designation, conditional approval during clinical trials, and priority review during marketing authorization to accelerate approval and address unmet medical needs
Regulatory authority for drug registration in China
The National Medical Products Administration (NMPA) is the primary authority responsible for pharmaceutical oversight, regulatory policy formulation, and review management.
Meanwhile, the Drug Evaluation Center (CDE) is responsible for evaluating clinical trial submissions, marketing authorization submissions, supplementary applications, and re-registration requests for overseas-manufactured products.
Who can apply for drug registration in China?
The Marketing Authorization Holder (MAH) is eligible to submit clinical trial submissions, marketing authorization submissions, re-registration requests, and supplementary materials. In addition, the MAH is responsible for ongoing obligations related to product safety, effectiveness, and quality control.
Medicinal product registration categories in China
The requirements to develop and register a medicinal product in China depend on its classification:
– Chemical medicines
– Biological products
– Traditional Chinese medicines
Each product type is further divided into specific categories that determine submission materials, including clinical trial and marketing authorization documentation.
Registration categories for chemical medicines
– Innovative drugs
– Improved new drugs
– Generic drugs
Registration categories for biological products
– Innovative biological products
– Improved new biological products
– Marketed biological products, including biosimilars
Accordingly, submission requirements are based on product characteristics, degree of innovation, and applicable review management principles.
Review process for marketing authorization
After completing pre-clinical and clinical studies, the applicant submits a marketing authorization submission in accordance with regulatory requirements.
First, materials undergo formal examination. If requirements are met, the submission is accepted. Then, technical experts organized by the Drug Evaluation Center conduct a comprehensive review. Finally, a registration certificate is issued. Otherwise, the submission is not approved.
