July 1, 2022
The CTD for a drug has become completely electronic
Many pharmaceutical workers involved in the regulatory activities remember the times when a drug dossier was brought to the Ministry of Health of the Russian Federation in large bags. Sometimes a dossier for one drug took thousands of pages, and, of course, one mechanical work to collect a paper dossier was a laborious task. Everything changed with the introduction of a modular dossier system, where only Module 1 was required on paper. Finally, in March 2022, the drug registration dossier became fully electronic.
According to Appendix No. 1 to the Rules for Registration and Examination of Medicines for Medical Use, “The registration dossier can be submitted in electronic form, without additional submission of relevant documents and information on paper.”
Now all dossiers must be uploaded through the personal account of the Federal State Budgetary Institution NCESMP. To do this, the applicant must issue a power of attorney to a user authorized on the website of the Federal State Budgetary Institution NCESMP. Further, the expert institution checks the full name of the employee specified in the power of attorney and the user whose unique identifier is indicated in the power of attorney. If a discrepancy is detected, the power of attorney is not accepted, and access to the service is not provided.
The most simplified sequence of actions when submitting an electronic dossier is as follows:
Figure 1 Submission of the dossier in electronic form (slide from the presentation of the Head of the Control and Organizational Department, Candidate of Biological Sciences, Rychikhina E.M.)
Thus, according to the new procedure, only applications with confirmation letters are required to be submitted to the Ministry of Health of Russia.
- Materials of the SCIENTIFIC-PRACTICAL CONFERENCE “MODERN APPROACHES TO THE EXAMINATION AND REGISTRATION OF MEDICINES” REGLEK — 2022
- Decision of the Council of the Eurasian Economic Commission dated 03.11.2016 No. 78 (ed. 23.12.2020) “On the Rules of Registration and Expertise of Medicines for Medical Use”
