China’s pharmaceutical drug market is constantly growing and is the second-largest pharmaceutical industry in the world, after the United States. It is estimated to reach $161.8 billion by 2023, with an average growth rate of 5% in the coming years, taking a 30% share of the global market.
The acceleration of new drug access, changing regulatory landscape of individual categories, the rapidly aging Chinese society, and subsequently increasing medical needs provide a range of opportunities for the pharmaceutical market.
After 13 years, the Chinese regulatory has made several changes in the rules and guidelines for registering drugs. These changes made are to reduce the complexity and match up with the other global regulators.
Let’s look at some highlights of new provisions made by the Chinese regulators
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The National Medical Products Administration (NMPA) is the main regulatory authority responsible for drug registration management, formulating drug registration specifications, and organizing drug registration review and approval.
NMPA’s Drug Evaluation Center (CDE) is responsible for the review of drug clinical trial applications, drug marketing authorization applications, supplementary applications, and drug re-registration applications for overseas manufactured drugs.
The Marketing Authorization Holder (MAH) can submit applications for drug clinical trials, drug marketing authorization, re-registration, and supplementary applications. Along with these duties, MAH can also handle various other duties.
The requirements to develop and register a medicinal product in China depend on further classification:
Each type is then classified into three registration categories, which determine the materials that the applicant must provide as part of its registration application example clinical trial application, marketing authorization application, etc.
For chemical medicines, registration categories are as follows
For biologics, registration categories are as follows
The corresponding application materials requirements are based on the product characteristics, degree of innovation, and review management needs of the registered medicines.
The drug category in which an applicant chooses to register decides the clinical trial application review and approval process. NMPA manages the clinical trial application.
The validity period of the drug registration certificate of drug Marketing Authorization Holder is five years. During the validity period, the MAH must take responsibility of the safety, effectiveness and quality controllability of the listed drugs and apply for drug re-registration six months prior the expiration of the validity period.
According to the regulation, NMPA initiated new drug review process and has divided the approval process into the following four categories
The applicant needs to know for which category of drugs do these review processes apply at which stage of drug development may apply.
The applicant is required to pay a fee per applicable regulations. The National Medical Products Administration (NMPA) charges the drug registration fees to review and approve clinical trials as a part of the drug registration process. The fees are different categories of drugs as below.
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