February 2022: Turkey Regulatory Update

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.

September 2021: Turkey Registry Update

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.

July 2021: Clinical Trial Data Reporting in EU Countries

In Europe, the enthusiasm for trials is not matched with a zeal for reporting the results to the public. Nearly 28% of completed European trials in the EU Clinical Trials Register (EUCTR) on 1 July—had not posted their results according to the latest data from the EU Trials Tracker, set up by U.K. researchers in 2018. Public research hospitals and universities are responsible for the vast majority of the lapses, which appear to violate European rules that require sponsors to post their results within 1 year of a trial’s conclusion.

Some researchers from public trial centers aren’t keen to disclose negative results and others believe publishing results in a journal fulfills the reporting requirement, even though journal articles can come years later and are often not made public. The Public Assistance Hospitals of Paris (AP-HP), the largest clinical trial center in Europe has reported results for just one of 35 trials completed more than 12 months ago, according to the EU tracker. More than 200 of the center’s trials are listed on EUCTR as ongoing, even though more than half of them began more than 10 years ago.

The current rules stem from 2001 European guidelines are considered as “soft legislation” and some nations seem to be taking advantage. According to current French regulations, there is no obligation to post results in the EU database, their priority has been to publish both positive and negative results in peer-reviewed journals. In the Netherlands, it is sufficient if sponsors post results in the Dutch trial registry, run by the Central Committee on Research Involving Human Subjects (CCMO). The CCMO website states that sponsors must also post results of medicines trials in the EU database, but Amsterdam University Medical Center (AUMC) does not follow that rule seeing any advantage in double registrations or in doubling researchers’ administrative burden.

Europe is getting more serious about enforcing the reporting requirements. Since the launch of the EU tracker in 2018, timely reporting of results has risen from 50% to 72% of completed trials. The European Medicines Agency (EMA) has stepped up reminders to trial leaders and has sent out about 30,000 reminders to overdue trial sponsors since 2018, another possible driver of improvement. Special notices go out for COVID-19 trials.

EMA’s new trial registry Clinical Trials Information System (CTIS) launch scheduled for Jan 2022 will eventually replace the EUCTR portal after a 3-year transition period and will end the tedious process of registering trials in each participating country. Sponsors will upload all trial data, from start to finish and the relevant national regulators will review the data before the information becomes public in one, linear, straight-through process. Once CTIS goes live, a 2014 European regulation will take effect, empowering national regulators in the European Economic Area to enforce the reporting of results. It will be for governments to decide how the national regulators should enforce reporting and what penalties they should impose for lapses.

Denmark, known for its vigilant regulation of drugs and trials already has a law that allows authorities to fine or imprison clinical trial leaders who do not meet deadlines for reporting results.

Additional details are found here.

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: Updated Fields of jRCT

Updated Fields of jRCT

Below updates were made to the jRCT system for “Regenerative Medicine Research” on December 25, 2020:

  • The number of files that can be uploaded for the attached documents (‘others’ which includes explanatory documents that cannot be included in the text) had been increased
  • The English name column was added for the Name of the administrator (representative administrator when conducting as a multicentre joint research) in the applicant information
  • The reception date/notification date is now displayed on the registrant screen.

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.

December 2020: Slovakia Regulatory Update

Updated Assessment Procedure of Documentation When Submitting Changes to Clinical Trials

State Institute for Drug Control (SUKL) posted the following update on December 02, 2020:

The SUKL / Department of Clinical Trials of Medicinal Products announces that the assessment procedure of documents (part of regulatory submissions) will change from 01 January 2021. The minor changes should be implemented and notified to SUKL along with the substantial changes as it will not be possible to add a minor change to the EU Portal / CTIS. The contracting authority is obliged to comply with the statutory deadline (35 days) after notification of the facts and implementation of substantial changes.

August 2020: Updated Fields of jRCT

Below updates were made to the jRCT system on August 31, 2020:

  • Entry column was added for the ‘Primary Sponsor’ field
  • The input fields of ‘Name of client, etc.’, and ‘Primary Sponsor’ were added for the ‘Other clinical research (*)’ field
  • The input field of ‘IPD sharing’ was added in the initial application/change application for the ‘Other clinical research (*)’ field
    (*) Observational studies, surgery, procedures, etc.

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.