China Drug Product Registration

Registration of Drug Products in China

Drug quality and safety are closely related to people's health. In order to effectively strengthen drug quality and safety supervision, Chinese regulators have made several changes to drug registration rules and guidelines, aiming to establish a strict drug safety supervision system. Drug registration refers to the examination and approval process by the National Medical Products Administration (NMPA) to systematically evaluate the safety, efficacy, and quality controllability of the drugs to be marketed according to the drug registration application and legal procedures, and finally decide whether to agree with the application. The current version of the Drug Registration Management Measures was adopted by the NMPA on January 15, 2020, and has been in effect since July 1, 2020.

NMPA is the main regulatory agency responsible for the development of drug registration regulations, drug registration management, and drug registration review. NMPA's Drug Evaluation Center (CDE) is responsible for reviewing applications for drug marketing authorization applications, drug clinical trial applications, supplementary applications, and drug re-registration applications for drugs produced overseas.

About Us

Our company provides scientific and regulatory support for China drug product registration.

As a trusted advisor on China drug product regulatory compliance, our company provides professional services related to the registration of chemical and biological drugs. Our professional technicians are familiar with the laws, regulations, and technical requirements for drug registration and maintain effective two-way communication with clients and government regulatory authorities in many aspects. We provide end-to-end consulting services and regulatory support for drug registration in China until approval from NMPA. Our extensive practical experience ensures the rapid progress of the project and helps clients reduce time to market.

Our Drug Product Registration Categories

• Registration of chemical medicine, including innovative drugs, improved new drugs, and generics
• Registration of biological products, including innovative biological products, improved new biological products, and marketed biological products
• Registration of traditional Chinese medicine

China Drug Product Registration Services

We provide comprehensive drug registration application services to our clients, including new drug applications, applications for drugs with existing national standards, applications for imported drugs, and supplemental applications. Our related services include but are not limited to:

• Drug product regulatory services and consulting solutions in China
• Authorized local agent for drug product registration application
• Drug classification and the determination of registration category and application type
• Collection and collation of application dossier checklist and data gap analysis
• Dossier preparation and document translation
• Customized dossier analysis including risk assessment and optimized registration strategies
• Assistance with communication with CDE reviewers
• Business strategy and regulatory market consulting
• Arrangement of the on-site audit or mock inspection
• Preparation and submission of supplemental applications or applications for change
• Regulatory intelligence
• Post-market approval services, including preparation, writing, and submission of annual reports and benefit-risk reports
• Regulatory software solutions
• Support for Translation Services

Our Advantages

• Experienced registration specialists
• Overseas multi-country registration experience
• Cost-effective strategies to ensure speed-to-market
• Keeping abreast of the latest regulatory trends and obtaining the latest information from regulators

If you need help or have a question, please feel free to contact us for more details.