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Clinical Research Organization

REGULATORY PATHWAY IN TURKEY

Regulation on Clinical Trials - Turkey


A new Regulation on Clinical Trials has been published in Official Gazette #28030 of 19.Aug.2011 and entered into force on the same date by Ministry of Health, the competent authority (CA) in Turkey.


This Regulation is issued based on:

  • Article 43, Decree Law #181 of 13.12.1983 on the Organization and Mandate of the Ministry of Health, and supplemental article 10, Fundamental Law #3359 of 07.05.1987 on Health Services; and
  • is aligned with Directives 2001/20/EC and 2005/28/EC of the European Union on Good Clinical Practice concerning medicinal products; and
  • is aligned with Directives 93/42/EEC and 90/385/EEC of the European Union on Medical Devices and Active Implantable Medical Devices, respectively
  • Ethics Committees


    Ethics committees will be comprised of (not less than seven and not more than fifteen) members with at least one of them a non-health care professional and one a jurist, and the majority consisting of health care professionals holding a doctorate or medical residency degree.


    Ethics committees will be assembled as:


  • Ethics Committee for Drug Clinical Trials,
  • Ethics Committee for Bioavailability/Bioequivalence Trials, or
  • Ethics Committee for Non-Drug Clinical Trials,
  • depending on the field of clinical research. However, at centers where clinical trials are conducted infrequently, it is possible to assemble only an Ethics Committee for Clinical Trials to review all clinical trials, excluding bioavailability/bioequivalence trials and comparability studies for biosimilars.

    The Ethics Committee for Drug Clinical Trials will form their opinion and communicate it to the applicant within thirty days after the application date. Permission of the Ministry is required to commence a clinical trial that has been approved by an ethics committee. The study sponsor will make an application to the General Directorate of Pharmaceuticals and Pharmacy to obtain permission of the Ministry.

    Advisory Board for Clinical Trials


    An Advisory Board for Clinical Trials will be established within the General Directorate of Pharmaceuticals and Pharmacy of the Ministry, with the Minister’s approval. The Advisory Board for Clinical Trials will comprise of members specified in supplemental article 10 of the Fundamental Law #3359 of 07.05.1987 on Health Services.

  • Reviews complaints filed against ethics committees and objections raised against ethics committee decisions, and gives its opinion to the Ministry.
  • Upon the request of the Ministry, gives its opinion on matters related to clinical trials requiring an expert opinion which have been referred to the Ministry by ethics committees or by parties to a clinical trial.

  • Guidelines for Conducting Trials


    The application dossier for a clinical trial will be prepared according to the Guideline for Good Clinical Practice and other applicable guidelines, using the application form and its relevant annexes posted on the Ministry’s website, and will be reviewed for Ministry permission and ethics committee approval according to this Regulation and the guidelines to be issued by the Ministry.In multi-center clinical trials, the scientific and ethical approval will be obtained of the ethics committee in the locality where the coordinating center is located, and notifications will be made to ethics committees in places where the other sites are located. The application for a clinical trial will be made to the relevant ethics committee or general directorate by the sponsor, consisting of natural/juristic person(s), or by a contract research organization domiciled in Turkey appointed by the sponsor. If the sponsor has no representative domiciled in Turkey, the application for a clinical trial must be submitted through a contract research organization domiciled in Turkey.

    If, after the commencement of a clinical trial, the need arises to make any of the amendments described in the Guideline for Good Clinical Practice, such amendment(s) will be notified to the ethics committee concerned, to be approved by the sponsor, and to the relevant general directorate. Should the amendments be found acceptable, the ethics committee will approve them within fifteen days, and the general directorate concerned within thirty days, to the extent they find the amendments acceptable.

    Investigational Products


    The responsibility rests with the sponsor to ensure that the investigational product, after it has been manufactured or imported, is stored, dispensed and delivered to the trial site in a manner compliant with the product’s characteristics, that these conditions are maintained at the trial site, that unused products are recovered from the trial site or are properly destroyed, and that a record of all of these processes is maintained or caused to be maintained. The responsibility rests with the principal investigator at each center for accepting the delivery of products, maintaining them, dispensing them according to written instructions and/or the study protocol, checking the inventory, and following the protocol requirements for and keeping a record of any remaining products. The principal investigator will appoint a pharmacist from the trial team to perform these functions. Permission of the Ministry must be obtained for manufacture and importation of investigational products; for medical devices, permission is necessary only for importation. The application to obtain such permission may be submitted by either the sponsor or a contract research organization authorized by the sponsor

    Adverse Events & Serious Adverse Events


    All adverse events mentioned in the protocol or the investigator’s brochure or adverse events occurring during the clinical trial and deemed as not requiring immediate reporting will be reported to the relevant ethics committee and the general directorate concerned within the timeframes specified in the protocol. The investigator will report all serious adverse events immediately to the sponsor, who is obligated to urgently report to the Ministry on this information. The sponsor will submit a detailed report on serious adverse events to the relevant ethics committee and the general directorate concerned within eight days. In the urgent report and in any follow-up reports, a single identifier will be used for subjects enrolled in the study

    Adverse events and/or laboratory findings identified as critical to safety evaluations will be immediately reported to the sponsor in the manner and timelines mentioned in the protocol. In the event of death of a subject, the investigator will supply the sponsor, the relevant ethics committee, and the general directorate concerned with any additional information requested. The sponsor will keep detailed records of all adverse events reported to it by the investigator or investigators. These records will be submitted to the general directorate concerned, if they so request.

    Once a year, the sponsor will provide the relevant ethics committee and the general directorate concerned with a listing of all suspected serious adverse reactions, including information relevant to subjects’ safety, using the interim report form provided in the relevant guidelines to be issued by the Ministry. In short-term studies or where necessary, the general directorate may request a report earlier.

    Miscellaneous and Final Provisions


    Confidentiality of documents related to a clinical trial is essential, and such documents may be disclosed to authorized parties only upon the request of legally authorized persons or bodies Clinical trials being conducted, trial sites, sponsors and contract research organizations, manufacturing sites of investigational products, laboratories where analyses relevant to the trial are being performed, and ethics committees mentioned in Article 10 herein may be inspected in and/or outside of the country by the Ministry, with or without advance notice, to determine compliance with this Regulation and other applicable regulatory provisions

    Inspectors of good clinical practice are obligated to maintain confidentiality of all information they acquire during inspection.

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