Recently, China Center for Drug Evaluation (CDE) has received feedback from overseas companies regarding Covid-19 impacts on drug application submissions; these impacts have included impact from closure of foreign embassies, travel disruption and international delivery services. As a result, required documentation could not be notarized, certified and delivered timely.
Taking in to account the important role of medicines in combating Covid-19. After investigation, CDE has decided to adjust the submission time and form of certifications of imported drugs (including clinical trial applications, marketing registration application, supplementary application and re-registration application) in order to ensure the smooth progress of imported drugs’ registration application. The details are as follows:
For the overseas drugs which cannot be notarized in foreign countries notarized or posted, the overseas holder or domestic registration agency shall illustrate in the special statement part of drug application form and submit electronically scanned version of certifications. In the statement, the applicant shall make a commitment to bear the corresponding legal responsibility of its authenticity, validity and consistency of original notarized certifications, and also promise that the original notarized certifications will be submitted completely before approval.
The registration applications according with the above situation could be accepted by CDE. The applicant shall take the responsibility of the rejection for not supplementing original notarized certifications according to relevant requirements before approval.
In addition, the electronic certifications issued by overseas drug administration departments will be approved.
The above content will be implemented since the release date. The time for normal submission time of certifications will be notified according to the pandemic situation.
Release Date: 2020.05.13