The process started beginning of 2014 when OCT was granted a phase III trial in patients suffering from ocular inflammation after undergoing uncomplicated unilateral cataract surgery.
This was an open-label, randomized, multicentre comparative study to assess the efficacy and safety of the investigational product which is eye drops for the treatment of ocular inflammation following cataract surgery.
OCT was fully responsible for the project starting from Essential Study Documents preparation and regulatory submissions, including management of the project, clinical monitoring, data management and statistics, and final study report writing.
OCT has prepared the package of documents and submitted the registration dossier to the Russian regulatory authorities, which was followed by obtaining approval of the Ministry of Healthcare (MoH) to conduct this study in the Russian Federation at the end of February 2014.
165 subjects have been recruited for the current study by the means of 8 medical centers within 6 months and have been undergoing treatment up to the end of 2014 when the investigational sites were closed, data base was locked, data was cleaned and final study report was prepared by OCT medical writers.
The last milestone was submission of the final clinical study report to the Regulatory Authorities earlier this month, so the “second step” had been performed and the process of the investigational product registration had been re-initiated.
OCT expect to get the Registration certificate for the investigational product at the end of September, 2015.
OCT strong expertise on local regulatory environment makes us a reliable partner for both Russian and foreign pharmaceutical and biotechnology companies whose goal is to bring their products to the Russian market.
To obtain marketing authorization of a drug in Russia, a registration dossier must be prepared and submitted to the MoH, which is followed by a second submission to obtain an approval for a clinical study conduct after the positive results of expertise of the submitted dossier are received.
OCT in-house registration manager with years of experience in the local market and regulatory environment can either prepare the registration dossier from scratch or review the package of documents provided by Sponsor and check it for compliance with the local standards.
After the clinical trial is completed and the final clinical study report is prepared by the team of OCT medical writers, it is submitted to the MoH to complete the registration dossier and re-initiate the process of drug registration. All the documents are analyzed by the experts and the registration certificate is issued to the study sponsor.