February 2022: Peru Update

The Peruvian Registry of Clinical Trials (REPEC) published a notification (PRESS RELEASE No. 006-2022-OGITT/INS) on February 03, 2022, stating that-

The services of REPEC Version 2 (V2) have been restored. All the documentation entered through [email protected] during the month of January to date must be regularized in the REPEC V2 in order to have the updated information of the clinical trials presented.

January 2022: Peru Update

The Peruvian Registry of Clinical Trials (REPEC) published a notification (PRESS RELEASE No. 005-2022-OGITT/INS) on January 26, 2022, stating that-

  • From January 06, 2022 (the date since which REPEC Version 2 [V2] is out of service), until the REPEC V2 system is enabled again, all documents must be directed to [email protected] and  [email protected] emails.
  • Once the system’s services are restored, this documentation must be regularized in the REPEC V2.

September 2021: Peru Update

A notification (PRESS RELEASE No. 005-2021-OGITT/INS) dated September 09, 2021, was published on the Peruvian Registry of Clinical Trials (REPEC) website on September 13, 2021. In the context of the same:

Due to preventive maintenance, services of the REPEC Version 2 System will be temporarily suspended as of Sunday, September 12, 2021. The services provided in the previous version of REPEC (REPEC Version 1) will continue as normal.

Note: As of September 24, 2021, the registry website (Version 2) is back to working.

July 2021: Peru Regulatory Update

The Peruvian Registry of Clinical Trials (REPEC) published a notification (PRESS RELEASE No. 004-2021-OGITT/INS) on July 23, 2021, as a reminder for the sponsors of clinical trials stating that the authorization of a clinical trial is granted for the total period of time scheduled for its execution. In this context, to request the extension of time for completion of the clinical trial, the sponsor must submit the documents as established in Article 80 of the Clinical Trials Regulations approved by Supreme Decree No. 021-2017-SA within 30 calendar days prior to the end of the validity of the clinical trial.

This is not added as new information, it is a part of the existing regulation.

July 2021: Russian Federation Regulatory Update

In Russia, the Registry of Approved Clinical Trials (RCT) is hosted by the State Register of Medicines. An update was posted on the State Register of Medicines notifying its users to change their passwords by 12 July 2021. This action has been undertaken to comply with the requirements of regulators in the field of information protection and prevent unauthorized access to resources of the information system.

June 2021: Slovakia Regulatory Update

Clinical Trials With Medical Devices: Questions About the EUDAMED Database and Regulation EP and R (EU) 2017/745 (MDR)

The State Institute for Drug Control (SUKL), regulatory agency of Slovakia, has posted an update addressing the questions related to registration in the EUDAMED database and the Regulations on Medical Devices [Regulation (EU) 2017/745]. The update provides information on the following: registration obligations for EUDAMED, Declaration of Responsibility for Information Security, notification of different classes of medical device (ZP) to SUKL, validity of certificates issued before 26 May 2021.

Additionally, the update also covers information regarding the devices lawfully placed on the market before 26 May 2021 and the timeline for the Unique Device Identification (UDI) carrier to be placed on the device. For further details please follow the link.

June 2021: Peru Regulatory Update

Measures Established for the Receipt of Documents by Documentary Procedure

Peruvian Registry of Clinical Trials (REPEC) published a notification (PRESS RELEASE No. 003-2021-OGITT/INS) on June 02, 2021. In context of the same:

The General Office of Research and Technology Transfer (OGITT) has enabled the below emails to streamline the procedures regarding the receipt of documentation submitted through the Documentary Processing System of the National Institute of Health (INS).

  • Submission of requests for documentary processing related to all types of new or ongoing clinical trials, not related to COVID-19 can be processed through [email protected].
  • Consultations and submission of applications for processing clinical trials related to COVID-19 can be done using [email protected].
  • [email protected] should be used for consultations related to all types of clinical trials, new or running, not related to COVID-19.

Documents that were sent to the [email protected] mail, as of June 7, 2021, must be sent to the [email protected] mail.

All requests must be addressed to the General Directorate of the OGITT-INS with the specific reason for the request along with a descriptive title. An infographic of the notification is also made available here.

June 2021: Slovakia Regulatory Update

Clinical Trials With Medical Devices: EP and R Regulation (EU) 2017/745 on ZP (MDR) – EUDAMED, UDI

The State Institute for Drug Control (SUKL), regulatory agency of Slovakia, published an update on 01 June 2021 that outlines the registration procedures related to EUDAMED. The update also details the ACTORS module and Unique Device Identification (UDI) process.

It covers the following points- role of the EUDAMED in data provision, various electronic systems within EUDAMED and their launch schedules, electronic system registration of economic operators under Article 30, and registration of manufacturers, authorized representatives, and importers under Article 31.

Additionally, it also incorporates the registration of economic operators and allocation of Germany under the ACTORS module, and information related to UDI- a standardized system for the identification of medical devices, along with the timetable for the introduction of UDI in the European Union (EU). Further information can be accessed through the link.

April 2021: Republic of Korea Regulatory Update

Notice for Partial Correction of Input Items and Changes to Existing Registered Research Data

Clinical Research Information Service (CRIS), the primary registry of Korea published a notice on 20 April 2021. In context of the same:

  • Recently, WHO ICTRP announced that some of the choices in the Study Data Sharing Plan for the International Clinical Research Registration Guidelines have been removed. In accordance with the same, CRIS has deleted the “Undecided” selection in the research data sharing plan and changed the registered research data. In case “tentative” is selected for existing registered studies, it has to be changed to “No”.
  • For previously registered studies, where “Undecided” was selected, the data will be changed to “No” collectively. Research that corresponds to data bulk changes will be sent to the registrar’s email. Sponsors can change it to “Yes” if their IPD sharing plan changes.
  • Modifications to input items and changes to existing registered research data are expected further.
  • Detailed information can be accessed through Announcements (nih.go.kr)

April 2021: Republic of Korea Regulatory Update

Notice of Temporary Suspension of the Functions of CRIS (Primary Registry of Korea) due to Homepage Renewal Work

Clinical Research Information Service (CRIS) published a notice on April 20,  2021. In the context of the same:

  • Due to the renewal of the Clinical Research Information Service (CRIS) website, functions related to clinical research registration are temporarily suspended (until April 22, 2021).
  • The functions of creating, submitting, supplementing, registering, and renewing clinical research are temporarily suspended. Other clinical research inquiry functions are serviced normally.
  • Modifications and changes related to input items are expected further.