10 Small Submissions
No more than 10 Documents per submission
China
Country: China
Health Authority: National Medical Products Administration (NMPA)
eCTD, Accepted Since: Dec 29, 2021
eCTD Version: eCTD CN V1.0 DTD V1.0, M2-M5 - v3.2.2
Types of Applications
The China National Medical Products Administration (NMPA) supports “Investigational New Drugs applications (IND), New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) Application Types.
Process to be followed to make an eCTD NMPA submission
- Compile all regulatory documents adhering to NMPA's eCTD standards and validate the dossier
- Initially, China eCTD Submissions will be submitted through CD/DVD, but at some point, gateway submissions will follow
- NMPA reviews the submission technically, scientifically, and regulatory for completeness, accuracy, consistency, and compliance
- NMPA may issue clarification requests, which must be responded to timely with additional information or clarification
- NMPA decides based on the review and responses, issuing a marketing authorization or other relevant approval if approved
Challenges faced in making an eCTD NMPA submission
- Complex eCTD Format: The Chinese eCTD format is more intricate than the global standard, making it difficult to navigate and implement.
- Language Barrier: Documents must be submitted in Mandarin with English translations, posing challenges for non-Mandarin speaking companies.
- Consistency and Validation: Ensuring consistency between paper and electronic submissions and rigorous validation of the eCTD dossier is crucial.
- Regulatory Changes: The dynamic regulatory landscape in China requires constant adaptation and compliance with evolving guidelines.
- Technical Expertise: A strong understanding of eCTD standards, technical specifications, and validation tools is essential for successful submissions.
How can Freyr help?
- Guarantee your ROI with an eCTD software that optimizes cost-per-submission
- Integration with inbuilt eCTD validator and PDF manager, submissions tracker and HA query management tool
- eCTD software solutions and services from the secure certified cloud, pay-per-use model on usage volume with minimal investment for more information on the same, consult us
Other Countries
USA, EU, Health Canada, Switzerland, South Africa, Australia, EAEU, Jordan, Thailand, GCC, ASEAN
