June 2021: Turkey Regulatory Update

New Medical Device Regulations came into force

As per the update posted on Turkish Medicines and Medical Devices Agency (regulatory agency of Turkey) on 14 June 2021, the “Medical Device Regulation” and the “In vitro Diagnostic Medical Device Regulation”, were published in the Turkish Official Gazette.

  • The “Medical Device Regulation” prepared in full compliance with the “Regulation (EU) 2017/745 on Medical Devices”  was published in the Official Gazette on 02.06.2021 and entered into force in a way that is valid as of 26/05/2021.
  • The “In vitro Diagnostic Medical Devices Regulation” prepared in full compliance with the “Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices” was published in the Official Gazette on 02.06.2021 and will enter into force on 26/05/2022.

For more detailed information, please click here.

December 2020: Turkey Regulatory Update

Revised Research Budget Form

Turkish Medicines and Medical Devices Agency (TITCK), the regulatory agency of Turkey posted the following update on December 30, 2020:

The Research Budget Form (KAD-FR-16) which is used to specify the financing of the research in the application files has been revised and put into effect as of 01.Jan.2021 to be used in research applications.

Based on the guideline updates, the initial application forms and change application forms were updated. Current forms are included in the announcement annex and can be accessed from the Application-Forms section of the relevant website address.

In this context, as of 01.Jan.2021:

  • In   applications, up-to-date application forms and research budget form should be used. Applications not made with updated forms as of 15.Jan.2021 will not be taken into consideration
  • If there is no change in the total budget figure declared in the budget form in applications to add a center due to the update made in the budget form, it is not necessary to submit the budget form

Note: These forms are not used for applications related to medical device research.

December 2020: Turkey Regulatory Update

Submission of annual notifications for the progress of clinical trials registered and not registered on Clinical Research Portal (KAP)

Turkish Medicines and Medical Devices Agency (TITCK), the regulatory agency of Turkey posted the following update on December 11, 2020:

Annual notifications covering the dates 01.Jan.2020 – 31.Dec.2020 must be made until 31.Jan.2021. As of 01.Jan.2021, annual notification is mandatory for all studies that are authorized by the institution and are ongoing (the final notification has not been submitted to the institution).

  • Studies enrolled in the Clinical Research Module: Annual notifications of trials registered in the Clinical Research Module will be made by filling the information in the module. If an annual notification form is submitted, these forms will not be taken into consideration. It is sufficient to submit only a cover letter and fill in the notification in the Module. The cover letter sample is available on the Clinical Research page.
  • Clinical Trials Module registered to non-research: For annual notifications of trials not registered in the Clinical Research Module, using the annual notification form, the Electronic Application System will be submitted through the General Documents Application. Submission of the cover letter and annual notification form is sufficient. Cover letter and form sample can be accessed on the Clinical Research page.

Click here for the original news.

March 2020: Turkey Registry Update

New Version of Clinical Research Portal (KAP)

On 17 March 2020, a new version of KAP is available. The new version of the Portal contains information about the researches applied to the Agency in 2016 and after and the researches and Bioavailability/Bioequivalence studies completed as of 01 January 2020 are not available on the Portal.

February 2020: What’s New on ClinicalTrials.gov PRS

ClinicalTrials.gov PRS posted following updates for February 13, 2020:

PRS Guided Tutorials: Registration Coming Soon, Tutorials Will Replace PRS Help

Registration content will be added to the PRS Guided Tutorials in early March. At that time, links to the tutorials will replace the current Help content available through PRS module help pages. We will continue to collect feedback on the PRS Guided Tutorials through a survey, intended to help us develop improved content and features.

Provide Your Comments to the ClinicalTrials.gov Request for Information

The National Library of Medicine is requesting public comment to guide efforts to enhance and better support the users of ClinicalTrials.gov, particularly within the following topic areas: Website functionality, information submission processes, and use of data standards. For consideration, your responses must be received electronically by March 14, 2020 using the web-based form linked from the Request for Information.

February 2020: What’s New on EudraCT

EudraCT has posted below notification:

As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period.

The transition period began on 1 February 2020 and is due to end on 31 December 2020.

January 2020: What’s New on ClinicalTrials.gov

Following updates were posted on ClinicalTrials.gov, on January 29, 2020:

  • Modernization Webinar Materials Available: A recording of the January 22 webinar and slides have been added to the ClinicalTrials.gov Modernization page.
  • New Advanced Search Fields: Two new fields have been added to the Advanced Search page: Results First Posted and Results Submitted. Results First Posted can be used to find studies based on the date summary results were first available on ClinicalTrials.gov. The Results Submitted field can be used to find study records based on whether the study sponsor or investigator has submitted summary results information and if submissions with QC comments are available.
  • National Library of Medicine Technical Bulletin Article on Updated Posting Procedures: This article highlights key features of the recent updates to ClinicalTrials.gov procedures for posting results information submitted for applicable clinical trials.

January 2020: What’s New on ClinicalTrials.gov

ClinicalTrials.gov updated the What’s New section on January 7, 2020, with the following update :

  • ClinicalTrials.gov Modernization RFI: The National Library of Medicine (NLM) has issued a Request for Information (RFI) seeking public input to guide us in planning infrastructure enhancements aimed at ClinicalTrials.gov users and submitters as part of a multi-year modernization initiative. For more information on opportunities to engage with us to enrich and modernize ClinicalTrials.gov, see this guest post on the NLM Musings from the Mezzanine blog.
  • Webinar on ClinicalTrials.gov Modernization and How to Provide Input: Join us for a webinar on January 22, 3:30-4 pm ET, about ClinicalTrials.gov Modernization. Register to learn more about the modernization efforts, the RFI, and ways to share your feedback. A recording of the webinar and slides will be made available for those who cannot attend live.

December 2019: What’s New on ClinicalTrials.gov PRS

ClinicalTrials.gov PRS posted following update on December 30, 2019:

Changes to Posting Procedures for Applicable Clinical Trials

Consistent with requirements under 42 CFR 11.52, NIH must post results information for applicable clinical trials (ACTs) on the public website within 30 days of submission, regardless of whether the quality control (QC) review process is complete. For more information, see the Final Rule (42 CFR Part 11) Information page.

As of midnight EST (05:00 UTC), January 1, 2020, initial results submissions for ACTs that do not meet QC criteria will be posted publicly on ClinicalTrials.gov along with the brief standardized major issues. For details on the new procedures see the ClinicalTrials.gov Webinar: Updated Quality Control and Posting Procedures.

Major Comments List

The complete list of ClinicalTrials.gov Major Comments (issues) that may be provided to the responsible party by National Library of Medicine staff during QC review is now available on the ClinicalTrials.gov public website. This list will be updated as major comments are added or retired from use.

December 2019: What’s New on ClinicalTrials.gov

What’s New section of the ClinicalTrials.gov was updated with the following post on December 17, 2019:

  • Implementation Update on Changes to Posting Procedures for Applicable Clinical Trials: The Training Materials and Final Rule (42 CFR Part 11) Information pages have been updated to specify the implementation date for the change in procedures to meet the requirement to post results information for applicable clinical trials within 30 days of submission. As of January 1, 2020, initial results submissions for applicable clinical trials that do not meet quality control criteria will be publicly posted on ClinicalTrials.gov with brief standardized major comments. Also available is the Major Comments List containing the complete list of brief standardized major comments that may be provided to the responsible party by National Library of Medicine staff during the quality control review conducted to identify apparent errors, deficiencies, or inconsistencies in a submitted study record.
  • New England Journal of Medicine Article on Results Information Submission: This article describes the current requirements, challenges, and opportunities for results information submission, 10 years after the ClinicalTrials.gov results database was launched. This and other publications by ClinicalTrials.gov staff are available on the Selected Publications page.