Turkey: Way To A New Era For Clinical Trials In Turkey

Last Updated: 31 August 2011
Article by E. Sevi Firat

Legal aspect of clinical trials occupies the agenda of medical and pharmaceutical sector as of the cancellation action filed by the Turkish Medical Association ("TMA") in March 2009 against certain provisions of the Regulation Pertaining to Clinical Trials dated 2008 ("Regulation"). In course of time, legal grounds of the clinical trial legislation became subject to a profound debate.

The 10th Chamber of Council of State, who examined the action, ruled on stay of execution of some articles of the Regulation in November 2009 due to miscellaneous reasons, such as payment shall not be done to the volunteers as a result of their participation in clinical trials and they shall be informed and enlightened by a person who is independent from the research team; concurrent applications shall not be made to Ethical Committees and General Directorate of Pharmaceuticals and Pharmacy and it is not possible for the changes in protocols become effective unless such are approved; the impossibility of establishment of constant committees, namely Ethical Committees and Clinical Trials Consultative Committee by a regulation, such shall only be established by a law or under the authority of the High Council of Health. The Council of State, with this interlocutory stay of execution decision, prevented implementation of these provisions until a final decision is rendered on merits of the action and proceeded with the next examination stage in order to reach a final decision.

Upon this decision, the Ministry of Health ("MoH"), without waiting for finalization of the pending action, chose to constitute ethical committees within the scope of the High Council of Health by reflecting the above mentioned alterations to the Regulation on March 11, 2010. On the other hand, both the MoH and TMA filed a review request with the Plenary Session of the Chambers for Administrative Cases of the Council of State ("PSCAC") being the higher chamber of the 10th Chamber.

The review decision that was rendered by PSCAC in July 2010 initiated hot debates. With this decision, the decision of the 10th Chamber of Council of State is taken one step forward. It is underlined that the Regulation was directly related to right to life and immunity of physical integrity, which are among primary fundamental human rights, and the trials in scope of the Regulation constitute intervention to immunity of physical integrity, this basic human right could only be limited by law even in case of existence of subject's consent and it would be against the Constitution that a person be subject to scientific and medical experiments unless authorized by law. This decision gave rise to the interpretation that the Regulation became invalid from a legal aspect. Upon this decision, the MoH ceased accepting trial applications on October 1st, 2010 and this led to concerns with regard to the status of the ongoing trials.

Consequently, leading universities in clinical trials decided to take the required steps in order to continue clinical trials and constituted independent Ethical Committees within their scope by adopting the interpretation that universities are granted authority by the Higher Education Law to conduct scientific trials including clinical trials. And upon this development MoH announced that they continue accepting clinical trial applications.

In May 2011, the 10th Chamber of Council of State delivered its final judgment on the action. In this decision, contrary to PSCAC, it is accepted that the MoH has appropriate legal grounds to regulate clinical trials and the rules regarding clinical trials could be set forth under a legal text with the force of a regulation1. In April 2011 the TMA appealed the decision and appeal application is still under examination of the PSCAC. However, considering below summarized developments, the final decision is expected to be in direction of an approval of the decision of the 10th Chamber.

On the other hand, it is not ignored that the aforesaid developments have given rise to the necessity to enact a law in order to maintain an appropriate and legitimate background for the conduct of clinical trials and enactment procedures are initiated rapidly. By way of adding an article ("Law") to the Principal Law on Health Services no. 3359 on April 6, 2011 that appropriate legal ground was provided. This provision, which contents with drawing the general frame of clinical trials, leaves the details to be set forth by the MoH through issuing regulations.

Following the entry into force of the Law, the MoH acted quickly and issued a new clinical trial regulation ("the New Regulation") on August 19, 2011 which is based on the Law and the international treaties that Turkey is a party to, such as Helsinki Declaration.

Henceforward clinical trials in Turkey shall be conducted in compliance with below stated principles pursuant to the Law and the New Regulation:

  • Even though such is not explicitly stated within the Regulation, it could be inferred from joint interpretation of the relevant articles that it is not possible to carry out clinical trials in private hospitals, and only universities, education and research hospitals and other governmental hospitals and health centres can be appointed as trial institutions.
  • Either the pharmaceutical company that is to conduct the clinical trial (Sponsor) or the Contract Research Organization (CRO) that is assigned by this company shall be resident in Turkey.
  • Clinical trials on human beings with medicinal products and combinations, even though registered or permitted, observational studies on medicinal products, observational studies on medical devices; clinical trials with all other ingredients or products which can be conducted in humans, including medical devices, advanced therapy products, traditional herbal medicinal products, cosmetic raw materials or products; bioavailability and bioequivalence studies, comparability studies for biosimilar products, studies to be conducted on industrial advanced medical products and non-industrial advanced medical products, studies on stem cell transplant on humans, studies on organ and tissue transplant, surgical studies, gene therapy studies, as well as the clinical trial sites and physical or legal persons conducting clinical trials are all subject to the New Regulation.
  • The non-invasive clinical trials, else then the ones defined as observational studies, are left out of the scope of the Regulation and except from those, approval of the Ethical Committee is required for all of the above stated studies. However, due to some inconsistent wording in the New Regulation, definition of non-invasive still needs to be clarified.
  • The Ethical Committees are grouped into three as "Pharmaceutical", "Non-Pharmaceutical" and "Bioavailability/Bioequivalence (BA/BE)" Clinical Trials Ethical Committees. 2
  • Prior to the approval of the Ethical Committee; the issues such as objective of the trial; expected benefit, analysis of risks and damages; trial brochure; obtainment of consents of volunteers; insurance covering the researcher or sponsor and volunteer; research team; trial budget and places where the trial will be conducted shall be clarified.
  • It is possible to inform and enlighten the volunteer by a member of the research team in course of obtaining the consent of the volunteer.
  • During Ethical Committee approval phase, the Committee is permitted to request correction from the Sponsor or CRO only once and thus the approval procedure is aimed to be shortened.
  • Upon approval of the Ethical Committee, it shall be applied to the relevant general directorate of the MoH in order to obtain trial permission after filling the forms and preparing the annexes published and required by the MoH.
  • A pharmacist shall be assigned for storage, distribution, delivery, destruction of the trial product pursuant to the New Regulation; it is foreseen that the responsible pharmacist shall be notified during the course of the approval application before MoH.
  • Following the approval of the MoH, the trial is expected to be conducted in line with the Law, New Regulation and the relevant guidelines.

Another recent development regarding clinical trials is the new Medical Device Regulation which is published in the Official Gazette and entered into force on June 7, 2011.

Article 15 of the Medical Device Regulation sets forth special provisions regarding medical device clinical trials while the Regulation Pertaining to Clinical Trials envisages general provisions for all types of clinical trials including medical device trials. The Medical Device Regulation can be deemed as an exact adoption of the EU Directive no. 93/42/EEC in general view.

Issuance of new rules for medical device clinical trials, while the Regulation Pertaining to Clinical Trials covering medical devices is still in force, give rise to questions regarding which set of rules has priority of implementation. Considering that there are huge legal gaps concerning clinical trials in the Medical Device Regulation such as details of the Ethical Committee approval procedure, the principles regarding the protection and insurance of trial subjects, the details of the ICF, the standards of the places where the trial will be conducted, the specifics of the trial approval of the MoH, the conduct of the trial, the responsibilities of the parties, the import of the trial product, adverse event reporting etc., the Regulation Pertaining to Clinical Trials still remains as an important and effective guide for the conduct of the medical device trials. Also, from a legal point of view, as the New Regulation Pertaning to Clinical Trials is published at a later date, it shall prevail over the rules set forth under the Medical Device Regulation as far as there is a contradiction between the same.

Since the medical device clinical trial related provisions are recent and unimplemented, changes in the latter are expected upon practice. However, at first glance, the below stated principles seem to be in force in order to conduct a medical device trial;

  • The objective of a medical device clinical trial shall be to verify that under normal conditions of use, the performance of the devices conform to those referred to in Annex I of the Medical Device Regulation, and to determine any undesirable side-effects, under normal conditions of use, and to assess whether they constitute risks when weighed against the intended performance of the device.
  • In case the clinical trial is conducted using a medical device bearing CE marking for the purpose that is referred to in the relevant conformity assessment procedure, only the provisions of Annex X of the Medical Device Regulation which are in line with the EU rules are applicable.
  • Prior to applying to the MoH for approval, Ethical Committee approval shall be obtained in accordance with the new Regulation Pertaining to Clinical Trials.
  • In accordance with Article 15 of the Medical Device Regulation, manufacturer or its authorized representative should prepare a declaration consisting of the data allowing identification of the device in question, a trial plan, investigator brochure, undertaking of insurance coverage for trial subjects, informed consent form, statement whether any substance included in Annex I/7.4 of the Medical Device Regulation or human blood derivatives is contained in the device, whether animal based tissues are used in the device, the opinion of the Ethical Committee concerned and details of the aspects covered by its opinion, the name of the medical practitioner or other authorized person and of the institution responsible for the trial, the place, starting date and scheduled duration for the trial, statement that the device in question conforms to the essential requirements apart from the aspects covered by the trial and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient. It should be noted that the manufacturer declaration to be filed to the MoH consists of a broader and more detailed document when compared with the declaration envisaged in the EU Directive.
  • Clinical trials must be performed on the basis of an appropriate trial plan reflecting the latest scientific and technical knowledge and defined in such a way to confirm or refute the manufacturer's claims for the device; these trials must include an adequate number of observations to guarantee the scientific validity of the conclusions.
  • The procedures used to perform the trials must be appropriate to the device under examination and must be performed in circumstances similar to the normal conditions of use of the device. All the appropriate features, including those involving the safety and performance of the device, and its effect on patients must be examined.
  • All adverse incidents must be fully recorded and notified to the MoH.
  • The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the data collected during the clinical trial.
  • According to Article 15, the MoH shall, if necessary, take the appropriate steps to ensure public health and public policy. In case the MoH refuses, ceases, suspends, demands significant alteration, it shall inform the European Union Commission. Similarly if the trial is terminated early due to security reasons, the EU Commission shall again be informed. In such way, different from other types of trials, medical device trials are maintained to be monitored in an international platform.

Given the latest developments, it could be stated that the problem related to the legal ground of clinical trials is almost solved. In our opinion, the problems that might arise during the implementation phase, especially related to medical device trials, can be solved by the MoH personnel, researchers and other related persons who are endowed with experience in the field.

However it should be borne in mind that there are still plenty of issues required to be solved by means of general principles of law. For instance, some issues remain unanswered within the scope of the clinical trial related legislation such as preparation of clinical trial protocol and trial reports; protection of clinical trial data; liability and limits of the sponsor, physician and research institution; the scope of damage and liability insurances. Consequently, it seems that all shareholders who take part in clinical trials need to put more effort to understand limits of their responsibilities and liabilities under the related legislation focused to protect human life.


1. The 10th Chamber of Council of State rejected demands of TMA except the volunteers being offered remuneration and being informed by the research team.

2. It is possible for the trials that are falling into responsibilty of "Pharmaceutical" and "Non-Pharmacological" Ethical Committees to be examined by only one Ethical Committee that is to be established as Clinical Rtrials Ethical Committee; however a seperate Ethical Committee shall certainly be established for BA/BE studies.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement

    Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of www.mondaq.com

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at enquiries@mondaq.com.

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.

    By clicking Register you state you have read and agree to our Terms and Conditions