Highlights of China’s New Regulations for ANDA Submission
- Conditional acceptance of foreign clinical data,
- Fast track review pathway,
- Simplification of bioequivalence (BE) study application,
- Adoption of ICH M4 CTD format for drug dossier.
Fig.1 Regulatory Reform and Impact on Generic Drug Import Market
TERM: BE Bioequivalence; ICH The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; CTD Common Techincal Document
Who can apply for an ANDA in China?
Generic Drug Development Requirements
Reference Listed Drug (RLD)
Clinical Trial/BE Study
NO CLINICAL STUDIES REQUIRED IN CHINA
|Clinical study exemption|
CLINICAL STUDIES REQUIRED IN CHINA
|Foreign clinical data available||Data fully accepted||Clinical study exemption|
|Data partly accepted/rejected||Clinical trial*/BE study required|
|No foreign clinical data||Clinical trial*/BE study required|
ANDA Submission Requirements
TERM: ANDA abbreviated new drug application; NMPA National Medical products Administration; CDE Center for Drug Evaluation; CFDI Center for Food and Drug Inspection; NIFDC National Institutes for Food and Drug Control
- The administrative costs are approximately $80,000 if clinical studies have been or will be conducted,
- or $60,000 if clinical studies are completely exempted.
Fast Track Review Pathway
Fig.3 Activities an ANDA Application can do before Application.
TERM: CDE Center for Drug Evaluation1. Have a Feasible & Strategic Plan for China Market
2. Apply for a CDE Communication Meeting (if needed)
3. Mind the Gap and Close the Gap
4. Follow Regulatory Updates
- Authorized local agent,
- Regulatory strategy plan,
- RLD confirmation & application,
- CDE communication meeting,
- Data gap analysis,
- ANDA dossier preparation, submission management & CDE review follow-up,
- Annual report,
- Pharmacovigilance (PV).