Documents

• 2013 GCP Regulation..
• 2014 amendment of 2013 GCP Regulation..
• Updated Regulation Clinical Trials of Medicinal and Biological Products (2014)..
• Bylaw on The Safety of Medicinal Products (2014)..
• Regulation on Clinical Trials - 08/2011
• Regulation on the amendment of Clinical trial regulation (2010)
• Headings For Aspects Of A Clinical Trial That Might Require A Substantial Amendment
• GCP regulation (2008)
• Information and Documents For The Import Of Drugs To Be Used In Clinical Drug Trials and Documents To Be Included In the Application File To Be Prepared For The Control Of The Centers Performing Bioavailability And Bioequivalence Studies
• Regulation Regarding the Implementation and Inspection of the Support for Research & Development Activities
• Regulation on Licensing for Medicinal Products for Human Use
• Regulation on Drug Research in Turkey (1993)

• Draft guidance for non-commercial clinical trials (2006)
• EU Directive 2004/10 on the GLP regulation harmonisation..
• EU Directive 2004/9 on the inspection of GLP
• [Regulation (EC) No 1901/2006 on medicinal products for pediatric use
• EU Directive 2001
• EU Directive 2005 28 EC

Guidelines - OUTDATED

• Bylaw on Clinical Research (2013) (English)..
• Guidance On Insuring Volunteers In A Clinical Trial (2011)
• Guideline For Observational Studies Conducted On Drugs (2011)
• Guideline Regarding Application Format for Application to Ethics Committee in Clinical Trials (2011)
• Guideline Regarding Application Format for Application to Ministry in Clinical Trials (2011)
• Guideline Regarding Independent Data Monitoring Committees (2011)
• Guideline on Storage and Distribution of Investigational Products (2011)
• Guidance on Observational Studies with Drugs (2010) (old version)
• Guidance on Ethical Considerations for Clinical Trials on Medicinal Products with the Pediatric Population (2010)
• Guidance On Insuring Subjects In A Clinical Trial (2009)
• Guideline regarding application format and documentation to be submitted to in an application for ethics committee opinion clinical trials (2009)
• Guidance on Observational Studies Performed with Drugs in Turkey (May 2008)..
• Guidance on Planning, Conducting and Evaluating Observational Studies Performed with Drugs in Turkey (In English)..

• WHO Health Statistics of Turkey

• Documents needed for compassionate use..
• How to apply for device related clinical trials?
• How to perform observational studies in Turkey?
• How to submit adverse events to the ethical committees?

• Transparency in Clinical Research and Status in Turkey & Middle East
• Turkey's Position Regarding Clinical Drug Trials
• Evaluation of research ethics committees in Turkey
• Clinical Research Association: A Leading Civil Society Organisation in Turkey..
• Transparency in Clinical Research and Status in Turkey & Middle East..
• Footsteps of a New CRO Era in Turkey Driven by Enhancement and Increasing Clinical Trial Activities..
• Clinical Trials Journey of Turkey-Long and Thin Road..
• Orphan Drugs: R&D Challenges with Updates from Turkey and Middle East Countries..
• Patients? Motivation about Clinical Trials: A Local Perspective from Turkey...
• Challenges and Barriers to Academic Cancer Research..
• Clinical Scientific Research Potentials in Turkey
• New GCP Rules in Turkey
• Getting It Right: Being Smarter about Clinical Trials
• Turkey’s Position Regarding Clinical Drug Trials
• Turkey's Trial Status

• Clinical Trial Application Form
• Clinical Trial Budget Form
• Ethics Committee Evaluation Form of a Clinical Trial Application
• Application Form Of A Clinical Trial For Specialty Thesis and/or Academic Purposes
• Notification Form To Obtain Ministry Approval And Opinion Of The Ethics Committee For A Substantial Amendment To A Clinical Trial
• Annual Notification Form To The Ministry And Ethics Committee For A Clinical Trial
• Application Form To Import Investigational Products For Clinical Trial Use
• Notification Form Of The End Of A Clinical Trial To The Ministry And The Ethics Committee
• Biological material Transfer Form (11 May 2009)
• Post-marketing adverse event report form (in Turkish)
• Severe Adverse Event Reporting Form (In Turkish)
• 6 Monthly Progress Report Form (In Turkish)

• WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks
• CIOMS - International ethical guidelines for health-related research involving humans (2016)
• ICH-GCP E6(R2) (2017)
• Helsinki Declaration - Seoul 2008..
• Nuremberg Code

• EC Guidelines On Medical Devices (April 2004)
• For Q&A related to this subject go to..
• Regulation on Medical Devices (In Turkish -2007)
• Regulation on Invitro Diagnostic Medical Devices (In Turkish -2007)
• Regulation on Active Implantable Medical Devices (In Turkish - 2007)
• Classification of Medical Devices

• Why invest in Turkish Pharmaceutical Industry? (2021)
• Clinical Development Success Rates 2006-2015
• Corruption In The Pharmaceutical Sector..
• Clinical Research in Turkey (pps)..
• Patient Rights (ppt)
• National Regulations on Ethics and Research in Turkey

• Comparative Data on 10 Regulatory Authority..

• New Law on Clinical Trials (2011)
• Law on Supporting Research and Development Acitivities (2008)

• Clinical Trial Application for Bioavailability and Bioequivalence Studies (07 May 2009)
• Documents To Be Included In the Application File To Be Prepared For The Control Of The Centers Performing Bioavailability And Bioequivalence Studies
• Bylaw on Bioavailibility and bioequivalance (1994 - in Turkish)
• Documents required for Firms, which will make their LABORATORY practice of bio-availability, bio-equivalence studies in abroad centers..
• Documents required for Firms, which will make their CLINICAL practice of bio-availability, bio-equivalence studies in abroad centers..

• Clinical Research Advisory Committee Standard Operating Procedures
• Standard Operating Procedure Of Ethics Committees