In order to improve the management of the electronic filing for drug registration applications, and to enhance the internet-based drug regulation service, the NMPA (National Medical Products Administration) decided (No.119-2021) to fully develop and promote the filing system of the electronic Common Technical Document for Drugs (eCTD) on September 29, 2021.
Starting from December 29, 2021, the registration of chemical drugs which belong to the class 1 and class 5.1, and the registration of class 1 therapeutic biological products and class 1 preventive biological products can be conducted through this eCTD filing system.
Scope of application
The eCTD is applicable to the clinical trial application, marketing authorization application, re-registration application, and other supplementary applications for chemical drugs and biological products. In vitro diagnostic reagents which are managed as biological product are not included.
Basic requirements
- Applicants should prepare and submit an eCTD CD-ROM containing the application files, according to the requirements for the eCTD technical documents, and submit the corresponding paper materials within 5 work days after the acceptance of the eCTD CD-ROM. If applicants do not submit paper materials within the prescribed time, the registration process will be terminated. At the same time, the applicant should promise that the submitted electronic materials are completely consistent with the content of the paper materials. Any problems arising from the consistency of the materials shall be borne by the applicant. The applicant shall also ensure the authenticity of the submitted eCTD application materials.
- After the applicant submits the application materials by using the eCTD, all subsequent submissions, including preliminary supplementary submission and technical supplementary submission, etc., should be also conducted through the eCTD, the paper materials will no longer be accepted.
Specific requirements
- The choice of storage medium and the requirements for disc-burning – If there are too many application materials and thus the capacity demand is large, the applicant should use one DVD instead of multiple CDs. If applicants must use multiple discs, they shall split the content according to the different modules. It is recommended that applicants use storage media with faster read and write speeds to improve the reading speed of the application materials, such as 16x DVD discs. In order to reduce the security risk brought by the storage medium during delivery and transportation, the storage media submitted to the regulatory agency will not be returned to the applicant.
- Disc cover information – Applicants should fill in and then print the cover information for the disc from the online drug application system of NMPA. It should be pasted on the surface of the disc box and submitted along with the application materials.
- Virus check – Applicants need to perform virus inspection on the submitted eCTD materials in advance and provide a virus check statement in an explanatory letter. After receiving the application materials, a virus check will be carried out later by the NMPA. If a virus is found, the application materials will be rejected.
- Technical Verification – After all the eCTD application materials are prepared, applicants should use a professional verification software (Applicants can download a free version of the verification software from the Pharmacovigilance website of the CDE) to verify the application materials. The verification software will generate a corresponding report after the verification is completed. The verification report will indicate whether there are “errors” in the materials and inform the applicants of possible problems through “warnings”. If the report shows “error”, it means the corresponding standard marked is a key standard that must be followed. Any “errors” will lead to rejection of the application. If the report shows “warning”, it means this standard marked is a recommended standard. It is recommended that the applicants solve this problem before the official submission.
By Sun Jinlin. Contact Cisema if you would like to learn more.
