Authorisation
What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Clinical trials for pharmaceutical products are regulated by the Regulation on Clinical Trials of Pharmaceuticals and Biological Products, together with several guidelines published by the Pharmaceuticals and Medical Devices Agency regarding specific topics. In order to undertake a clinical trial, ethics committee approval must first be sought, as well as agency authorisation where necessary. The authorised representative of the sponsor in Turkey or a contract research organisation domiciled in Turkey and authorised by the sponsor can apply for ethics committee approval; if the committee discovers that the trial's benefits are bigger than its possible risks, ethics committee approval is secured. It may later be necessary to apply to the agency with relevant information and documentation, including ethics committee approval, depending on the subject and subjects of the clinical trial. It is also possible to apply to the ethics committee and agency concurrently if preferred.
Clinical practices
How robust are the standard good clinical practices followed in your jurisdiction?
Good clinical practice is mainly regulated by the Good Clinical Practice Guideline and various supplementary guidelines published by the Pharmaceuticals and Medical Devices Agency in different specific topics. Considering that the clinical trials may be conducted only at centres determined pursuant to good clinical practice, trial applications are prepared in line with good clinical practice. The main issues (ie, determination of the changes that require ethics committee and agency approval or that have informative values only) are regulated by the Good Clinical Practice Guideline. Good clinical practice is well adhered to in Turkey.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
Pursuant to the relevant legislation, clinical trials which are approved by the Pharmaceuticals and Medical Devices Agency will be registered in a publicly available database on the condition that confidentiality of personal data is protected. In order to perform such a registration obligation, the agency has created a website (http://kap.titck.gov.tr/). The information provided in this publicly available database for clinical trials on pharmaceuticals and medical devices includes the status, number, type and name of the clinical trial, as well as the names of the coordinator physician and coordinator centre. There is no mandatory requirement to publish clinical trial results.
What are the informed consent obligations with respect to clinical trial subjects?
While conducting a clinic trial, the subject's consent is obtained confirming willingness to participate freely in a particular trial after having been informed of its nature. The trial subject's consent is documented in written form, with informed consent forms that include informative matters (ie, the nature, purpose, significance, duration, conditions, implications and risks of the study) and indicate the subject's right to withdraw from the trial at any time, as regulated by the Regulation on Clinical Trials of Pharmaceuticals and Biological Products. However, receiving informed consent forms does not eliminate the subject's right regarding the retrieval of loss arising from the trial.
INSURANCE
What are the insurance requirements for clinical trials?
Insurance procedures within clinical trials are regulated with the Regulation on Clinical Trials of Pharmaceuticals and Biological Products, together with a guideline published by the Pharmaceuticals and Medical Devices Agency. The insurance requirements and guarantees regulated in the said legislations are concerned with the clinical trial subjects participating in the trial and there is no explicit provision or regulation for insurance required for institutions and investigators. Even though a compulsory pecuniary liability insurance exists regarding medical malpractice for doctors, it does not usually include clinical trials.
Data protection
What data protection issues should be considered when conducting clinical trials?
In addition to the regulations in the recently published Law on the Protection of Personal Data, the clinical trials rules also confer specific importance regarding the protection of the personal information of the trial subjects and provides several restrictions on the data to be accessed by different parties. Accordingly, the sponsors or contract research organisations can access trial data only for monitoring purposes, to the extent allowed by law. Accordingly, these rules specifically govern that neither the case report form nor the adverse event reports will include the identification of the trial subject.
On November 24 2017 the Regulation Regarding Amendments within the Regulation on the Processing and Protecting the Privacy of Personal Health Data (the Amended Personal Health Data Regulation) was published in the Official Gazette, which introduced additional requirements regarding data protection when conducting clinical trials.
MARKETING AUTHORISATION
Authorisation
What is the marketing authorisation procedure for medicinal products in your jurisdiction?
In order to obtain marketing authorisation for a pharmaceutical product, a real person or legal entity domiciled in Turkey can make an application to the Pharmaceuticals and Medical Devices Agency in the common technical document form with certain information and documents, depending on the specialties of the product. The agency will complete an initial examination of the application dossier and request additional information and documents if required. According to the Licensing Regulation, in principle, an application must be reviewed and concluded by the agency within 210 days following submission. However, the agency does not follow this regulatory rule strictly and completion of a marketing authorisation issuance process may take approximately a minimum of two to three years, depending on deficiencies in the dossier. On the other hand, a new guideline was published by the agency in 2016, which aims to regulate prioritisation of review and issuance processes for some applications.
What criteria are considered in granting marketing authorisation?
The main criteria for consideration when granting a marketing authorisation should include product efficiency and safety, as well as satisfaction of the required technical and medicinal features. Having said that, the most important criterion for granting marketing authorisation is the issuance of a good manufacturing practice certificate for the relevant manufacturing site by the agency. The agency makes good manufacturing practice site inspections for the manufacturing facilities in Turkey and abroad. In the event of imported products, in most cases the agency will not accept a good manufacturing practice certificate issued by an EU authority only and conducts a site inspection at the facility located abroad.
What is the fee for obtaining marketing authorisation?
Fees for obtaining marketing authorisation vary depending on the status and type of the authorisation and product.
What is the validity period for marketing authorisation?
Pursuant to the Licensing Regulation, an application for the renewal of a marketing authorisation will be submitted to the Pharmaceuticals and Medical Devices Agency at least three months before the end of the first five years as of the marketing authorisation's issuance date, together with the pharmacovigilance data and information regarding quality, security and operation of the marketing authorisation and details of all changes that have occurred. Marketing authorisations must be renewed every five years accordingly.
What are the consequences of failure to obtain marketing authorisation?
Pursuant to the Licensing Regulation, none of the medicinal products which fail to obtain marketing authorisation from the Pharmaceuticals and Medical Devices Agency will be put on the market. As per the Pharmaceuticals and Medical Preparations Law, failure to obtain marketing authorisation risks imprisonment of between one and five years. Moreover, failure to obtain marketing authorisation for a product offered to the market may trigger certain criminal penalties pursuant to the provisions of the Criminal Code (765).
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.
