A trial program of electronic submission of China drug registration applications was announced by China’s Center for Drug Evaluation (CDE). The trial started on July 1, 2024 and runs alongside the existing CD-ROM submission process, providing applicants with flexible submission options. The option to submit online aims to improve efficiency in the submission process and format review of drug registration applications.
Key points:
- Effective Date: The trial for submitting electronic drug registration information started on July 1, 2024. During this trial, applicants can choose between two submission methods: CD-ROM or online transmission. However, it should be noted that the application can only choose one option and applications that have already been submitted via the CD-ROM method should not be resubmitted online. .
- Scope of the Trial: The trial covers drug registration declaration information prepared according to the “Technical Requirements for Electronic CD-ROM for Filing Information” or “Technical Specifications for eCTD” (Electronic Common Technical Document). For storage of electronic submissions exceeding 10GB, applicants must still use CD-ROM, as online transmission will only accept files up to 10GB.
- Additional Submission Requirements: When submitting through online transmission, applicants are required to submit a physical CD-ROM copy of the full declaration data within 10 days of the acceptance of the application or the formal receipt of data during the review process. This CD-ROM serves as a backup for verification purposes. If the application involves clinical trial data, an additional CD-ROM containing the clinical trial database must also be submitted, with the CD-ROM marked with the appropriate information.
- Verification Process: Upon submission, the electronic declaration data can be verified by the CDE using the “e-Declaration Data Verification Standard” or “eCTD Verification Standard.” If the data passes verification, it will be accepted for further review. Otherwise, applicants will be required to rectify the submission. The trial also stresses the importance of using pre-verification features within the electronic submission software to ensure compliance with the standards and avoid delays.
- Training and Support: To ensure smooth implementation and assist applicants in understanding the network transmission process, the CDE will offer training sessions through their online platform. This will help applicants familiarize themselves with the submission system and its requirements.
- Software Access and Procedures: Applicants interested in online transmission must make an appointment and apply for a certificate via the designated applicant window. They will then be able to download the necessary software, manuals, and videos for electronic submission. After installing the software, applicants can submit their registration data in compliance with the operation manual.
Impact for Pharmaceutical Manufacturers of the online China drug registration application submission process:
- Increased Efficiency and Streamlined Processes
- Faster Submission: The introduction of online transmission offers a more efficient alternative to the traditional CD-ROM submission method. It reduces the time and logistical effort required for physical submissions, enabling companies to submit their drug registration applications digitally.
- Reduced Processing Time: Consistent with the application package format of ICH member countries, it saves time in organizing application materials, and the online submission method piloted by CDE is gradually approaching ICH eCTD. Digital submissions can lead to quicker data verification and processing by the National Medical Product Administration (NMPA), potentially speeding up the drug registration approval process. This can be especially important for companies looking to introduce new drugs to the Chinese market or for those seeking re-registration.
- Greater Flexibility in Submission Options
- Multiple Submission Methods: Pharmaceutical companies now have the option to submit their data either via CD-ROM or through the new online transmission system, allowing for greater flexibility. The trial provides a transitional period, enabling companies to choose the method that best suits their current infrastructure and capabilities.
- Compliance and Risk Management
- Adherence to New Standards: Companies will need to ensure that their electronic submissions comply with the eCTD Verification Standard or e-Declaration Data Verification Standard. Failure to meet these standards could lead to delays or rejections in the drug approval process.
- Backup Requirements: Even with online transmission, companies are required to submit physical CD-ROMs within 10 days of submitting their electronic data. This ensures that data is backed up and can be verified in case of discrepancies. Regulatory managers will need to track these requirements closely to avoid delays or compliance issues.
- Future Regulatory Trends
Digital Transformation: This trial is part of a broader trend toward digital transformation in regulatory affairs. As the NMPA continues to enhance its “Internet + drug supervision” capabilities, it is likely that online transmission will become the preferred or even mandatory method for submissions in the future. Companies that invest early in digital tools and processes will be better positioned to adapt to future changes in regulatory requirements.
Further information
Read the original CDE announcement on China drug registration electronic submission – trial program.
Read our previous article on China drug registration electronic submission requirements updates from CDE.
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