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Entering the Chinese market
Our in-house expert team assures your smooth market access in China
We provide a one-stop customized solution for regulatory strategy and filing, NMPA interaction, and other support.
SOLUTIONS
At VCLS, we provide pharmaceutical regulatory consulting and product registration services tailored to the unique and dynamic regulatory landscape of China.
Regulatory strategy development
Agency interaction
Operational support
Regulatory intelligence
International collaboration facilitation
- Feasibility and gap analysis
- Product development strategy and regulatory roadmap
- Type I, II, III meetings and other forms of interaction
- Meeting briefing package preparation
- IND application
- Marketing authorization application
- Dossier preparation
- Ad-hoc advice on regulatory requirements
- CRO or CMO partner selection
Updates and insights into the Chinese regulatory environment, including policy changes, draft guidelines, and market authorization trends
Facilitate collaborations with international partners, providing guidance on cross-border regulatory requirements and strategies
Customized solution
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Provide tailored solutions that meet your specific needs and objectives
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Global team structure to ensure streamlined process and timely delivery
In-house expert team
- In-depth knowledge and understanding in Chinese regulation and legislation
- Scientific expertise in the fields of CMC, nonclinical, and clinical
Confidentiality & integrity
Maintaining the highest standards of confidentiality and integrity in all our engagements
FAQs
How long does it take to obtain clinical trial approval after Investigational New Drug (IND) filing and manufacturing drug approval, following New Drug Application (NDA) filing in China?
The average approval time for an IND filing for drugs can be within 60 working days.
China now utilizes a “silent approval” system, where if the National Medical Products Administration (NMPA) doesn’t respond to an IND application, it’s considered approved.
Expect the drug approval process through the NDA to take 1 year to 1.5 years on average, depending on the drug’s complexity, data completeness, and potential for additional inquiries from the reviewers. It is stated officially that NDA review takes 200 working days, or 130 working days with priority review.
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Do Chinese authorities accept the dossier in CTD format?
In 2017, China became a full member of ICH, demonstrating a commitment to aligning its regulations with international standards.
This means that CTD format is fully accepted by Chinese authorities, with regional differences in M1 of the CTD.
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Related Glossary
National Medical Products Administration (NMPA)
China’s Center for Drug Evaluation (CDE)
China Marketing Authorization Holder (MAH)
National Institutes for Food and Drug Control (NIFDC)
Chinese Pharmacopoeia (ChP)
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Questions? Get the answers from our expert team
No two product development paths are the same. Talk to our experts about your development challenges and we will provide you actionable recommendations.