Draft Regulation on Clinical Trials of Pharmaceuticals and Biological Products
Turkish Medicines and Medical Devices Agency (TITCK), the regulatory agency of Turkey posted the following update on February 02, 2022:
Within the scope of the efforts for the Turkey institution to be among the authorities listed by the World Health Organization, the Regulation on Clinical Trials of Pharmaceuticals and Biological Products published in the Official Gazette dated 13/04/2013 and numbered 28617 was amended.
The authority have prepared the “Comparison Table of the Draft Regulation on Clinical Trials of Pharmaceuticals and Biological Products” with changes made. Any comments regarding the draft can be sent via email using the Opinion Form to [email protected] by the end of February 10, 2022 and the comments would be evaluated by the authority.
For the draft regulation and opinion form, please check the original post.
New link available for registration
Turkish Medicines and Medical Devices Agency (TITCK), the regulatory agency of Turkey posted the following update on 17 September 2021:
As of 20 September 2021, EBS Provincial Health Transactions System, which provides service over https://ebs.titck.gov.tr, also serves at https://onlineislemler.titck.gov.tr. The same user name and password can be used by all defined provincial health users for login to the system.
For more information, please click here.
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.
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.
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.
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.
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.
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.
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.