Review of clinical and non-clinical trial reports – new regulation comes into force
From now on, all applications for the registration of new medicines must be in accordance with the newly adopted regulation (Order N 1528) on Disclosure of Preclinical and Clinical Research Data. This means that pre-clinical and clinical trial disclosure reports should be added to the dossier for medicinal product registration.
Report forms were also adopted by the appropriate order. Each study has its own separate report, which will be checked by the State Expert Center (SEC) for compliance of the information available in the dossier. In the case of a positive assessment, the SEC will issue a recommendation to the Ministry of Health to register the medicinal product, while also certifying that the information in the clinical and preclinical research reports is accurate.
We can anticipate that applicants’ submissions to the Ministry of Health for registration of new medicines can be a little delayed. After all, if the applicant plans to file a new registration in August or September of this year, he / she is unlikely to have the time and resources to complete all the reports according to the new standard. The order entered into force without a transition period and applicants did not have a definitive understanding of the format of the reports until they were approved and published. Therefore, applicants will now need some time to study and complete them. Moreover, for example, a large number of reports may be required for an innovative medicinal product, as reports are submitted for each of the studies. Therefore, some filing delays will unfortunately happen.
Representatives of the professional community discussed this order at the Ministry of Health in early August. The discussion was attended by representatives of the European Business Association’s Health Care Committee.
The Association’s Health Care Committee would like to thank the representatives of the State Expert Center of the Ministry of Health of Ukraine for providing information at the meeting on the process of reviewing the reports and clarifying the basic rules.
At the same time, in order to dig deeper into the rules of filling in the reports, discuss the nuances, consider some examples of already completed reports, it was agreed that a working meeting for a wide range of pharmaceutical companies with the participation of experts of the SEC will be hosted by the European Business Association in autumn. We are grateful to the SEC for this initiative. We hope this will help you to set up a new process effectively.