Adjust the time and form of submission of supporting documents for imported drugs during the epidemic
Published:
2020-05-14
Source:
医药网
Author:
On May 13, CDE issued a notice that due to the impact of the epidemic, when submitting an application for registration of imported drugs, notarized overseas documents could not be mailed or the supporting documents could not be notarized:
1. You can specify the items in the application form, submit the electronic scanned version of the certificate, and promise to bear the corresponding legal responsibility for its authenticity, validity and consistency with the original notarized certification;
2. Commitment to submit the original notarized and certified originals in one-time complete before approval;
3. Recognition of electronic certification documents issued by overseas drug regulatory authorities.
Attachment: Notice on Adjusting the Submission Time and Form of Proof Documents for Imported Drugs During the Epidemic Period
Recently, our center has received reports that due to factors such as the closure of foreign embassies, flight suspensions, and express delivery suspensions during the epidemic, when submitting an application for registration of imported drugs, the original certified documents that have been notarized overseas cannot be mailed, or the certification cannot be verified. Documents are notarized. At the same time, the European Medicines Agency (EMA) has issued a statement on March 30, 2020 that the new system will be used, and paper certificates will no longer be provided, only electronic signatures and authentication certificates will be provided.
Taking into account the important role of drugs in the fight against the new crown pneumonia epidemic, in order to ensure the smooth progress of the registration and declaration of imported drugs. After research, the submission time and form of the supporting documents for the registration application matters of imported drugs (including clinical trial application, marketing registration application, supplementary application and re-registration application) are adjusted as follows:
If the original notarized and certified overseas certification documents cannot be mailed, or the certification documents cannot be notarized and certified, the overseas licensee/registered agency shall explain in the special statement in the application form, and submit the electronically scanned version of the certification documents. Commitment to bear corresponding legal responsibility for its authenticity, validity and consistency with the original notarized certification. It also promises that the original notarized and certified copies should be submitted completely in one go before approval.
If the above circumstances are met, the original supporting documents and their notarized certification documents will not be required for the time being when the formal examination is accepted, and the registration application can be accepted. If the original notarized certification is not completed as required before the approval, the registration will not be accepted, and the applicant will be responsible for it.
In addition, the electronic certification documents issued by overseas drug regulatory authorities shall be recognized.
The above content will come into force from the date of this notice, and the time for the normal submission of supporting documents will be notified separately depending on the situation of the epidemic.
Center for Drug Evaluation, State Drug Administration
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