13 FAQs: Unlocking the Drug Approval Process in China

As you may know, China is a major pharmaceutical market with a growing demand for innovative drugs. However, the Regulatory landscape of the country can be complex and challenging to navigate for new as well. The FAQs mentioned below are designed to provide answers to common questions, which will help you bring your medicinal product to the Chinese pharmaceutical market with confidence.

Q1: What is NMPA?

A1: The National Medical Products Administration (NMPA) is the Chinese governmental agency that is responsible for regulating the development, production, and sale of pharmaceuticals, medical devices, and cosmetics.

Q2: What are the requirements for drug approval in China?

A2: To be approved for sale in China, a drug should meet the following requirements:

• It must be safe and effective.
• It must be of high quality.
• It must be manufactured in accordance with Chinese Good Manufacturing Practices (GMP).
• It must be labeled and packaged in accordance with Chinese regulations.

Q3: What is the drug approval process in China?

A3: The typical drug approval process in China consists of the following steps:

• The applicant submits a New Drug Application (NDA) to the NMPA.
• The NMPA reviews the NDA, following which it conducts an on-site inspection of the applicant’s manufacturing facilities.
• The NMPA may also request additional clinical data or other relevant information from the applicant.
• If the NMPA is satisfied with the NDA, it will approve the drug for sale in China.

Q4: How long does it take for a drug to be approved in China?

A4: The average time taken for a drug to get approved in China is approximately one (01) to two (02) years. However, the actual time may vary, depending on the complexity of the specific drug and the availability of clinical data.

Q5: What are the challenges of drug approval in China?

A5: Some of the challenges of drug approval in China include:

• The complex and ever-changing Regulatory landscape of the country.
• The high volume of NDA submissions made to the NMPA.
• The need to conduct clinical trials in China.

Q6: What are some tips for a successful drug approval in China?

A6: Here are a few tips you can follow for a successful drug approval in China:

• Carefully plan and execute your clinical trial program in China.
• Collaborate with a qualified Regulatory consultant to ensure that your NDA meets the NMPA’s requirements.
• Be prepared to respond promptly to any requests from the NMPA for additional information or data.

Q7: What are the different drug approval pathways in China?

A7: There are three (03) main types of drug approval pathways in China:

• The regular approval pathway, which is used for most new drugs.
• The priority review pathway, which is designated for drugs that meet certain criteria, for instance, if they address serious or life-threatening diseases.
• The conditional approval pathway, which is intended for drugs that address significant unmet medical needs, where the benefits of early access outweigh the risks.

Q8: What are the different types of clinical trials that are required for drug approval in China?

A8: The types of clinical trials you need to conduct to get drug approval in China vary, depending on the drug and the type of approval pathway that you are using. However, for most new drugs, you will have to conduct at least one Phase Three (03) clinical trial in China.

Q9: What happens after a drug is approved in China?

A9: Once a drug is approved in China, the Marketing Authorization Holder (MAH) is responsible for ensuring that the drug is manufactured, marketed, and sold in accordance with Chinese regulations. The MAH also needs to submit periodic safety reports to the NMPA.

Q10: What are the different types of drug registration applications in China?

A10: China recognizes four (04) different types of drug registration applications, which are:

• New Drug Registration: This is applicable for drugs that have never been approved before in China or in any other country.
• Generic Drug Registration: This pertains to drugs that are replicas of drugs that have already been approved.
• Clinical Trial Application: This is mandatory for all new drugs and most generic drugs before they can be tested in clinical trials in China.
• Import Drug Registration: This is required for all drugs that are imported into China for sale.

Q11: What are some of the common reasons for the rejection of drug registration in China?

A11: The most common reasons for the rejection of drug registration in China are listed below:

• Incomplete or inaccurate application materials
• Insufficient safety and efficacy data.
• Failure to meet manufacturing and quality control standards.
• Failure to meet packaging and labeling requirements.

Q12: What are the current trends in the drug approval process in China?

A12: Here are some of the current trends that can be observed in the drug approval process in China:

• Increased focus on innovative drugs.
• Increased acceptance of foreign clinical data.
• Increased utilization of priority review.
• Reduced timelines for review.

Q13: What is the success rate of drug registration applications in China?

A13: The success rate of drug registration applications in China varies, depending on the type of application and the complexity of the drug. However, the overall success rate is estimated to be around 70%.

Freyr is a global Regulatory solutions and services provider that can help you navigate all the aspects of the drug approval process in China. With a deep understanding of the Chinese Regulatory landscape and a proven track record of success, Freyr can help you bring your new drug to the market. Get a free consultation with our experts to discuss your specific needs and goals!