Last year, many legislative amendments were made in the field of health due to Covid-19. As welcoming 2021, we would kindly like to share information on the legislative amendments introduced concerning the clinical trials in 2020.
1. New Guideline on Import of the Clinical Trial Products
Guideline on Import of the Clinical Trial Products (“Import Guideline”) has been published by the Turkish Medicines and Medical Devices Agency (“TMMDA”) on the 26th of February, 2020.
Since the import of the clinical trial products had been regulated under Article 16 of the Regulation on Clinical Trials of the Medicines and Biological Products (“Regulation”) published on the Official Gazette dated 13th of April, 2013 and numbered 28617, the Import Guideline has a feature detailing the rules and procedures within this regard.
The Import Guideline regulates the details on:
Essential principals on import of the clinical trial products;
The required content of the pro forma invoices;
Instructions on the import applications to be made to the TMMDA;
Information on the evaluation period of the TMMDA.
2. Measures to be Taken in Clinical Trials Due to COVID-19 and Frequently Asked Questions
Guideline on Measures to be Taken in Clinical Trials Due to COVID-19 Pandemic (“Measures Guideline”) has been published by the TMMDA on 20th of March, 2020. Frequently Asked Questions related to the Measures Guideline (“FAQ”) has followed this publication on 20th of April, 2020. Both the publications have been updated on the 25th of July, 2020 by the TMMDA.
a. Guideline on Measures to be Taken in Clinical Trials Due to COVID-19
It has been specified under the Measures Guideline that the clinical trial sponsors are in a primary position to make regular risk analysis and organize and update their trial transactions accordingly. Risk analysis should be made by taking the priorities and emergencies arising from COVID-19 into consideration. The workload of the clinical trial sites must be decreased, and it must be ensured that the social isolation rules are being followed. The safety of the volunteers must be the priority.
Precautions and suggestions regarding the conditions below have been detailed under the Measures Guideline:
Suspension and early termination
Urgent safety measures
Protocol deviations/infringements
Monitoring activities
Supply of the clinical trial products
Laboratory and scanning services
Clinical trial site visits (patient visits)
Investigator meetings and trainings
Ethics committee meetings and applications to the ethics committee
Applications to the TMMDA regarding the ethics committee
Increase in the number of volunteers and additional trial sites
Applications to the TMMDA
Evaluation timelines/processes
b. Measures to be Taken in Clinical Trials Due to COVID-19 – Frequently Asked Questions (“FAQ”)
FAQ contains thirty Q&As in total, regarding the measures to be taken in clinical trials due to COVID-19. Certain significant questions from the published FAQ are as the following:
How and when to apply for urgent safety measures?
Can urgent security measures be presented on a company basis, covering all the trials?
Can the trial product be transferred to the volunteers via a logistics company?
Which rules should be followed in trial product transfer?
Can the locations such as private clinics and family health centers be included in the trial as trial sites?
Can a new trial site be included in the trial within the scope of urgent safety measures during this period?
What should be considered during the volunteer visits to be conducted at homes?
How should the volunteer consent be obtained for temporary or permanent volunteer transfers between trial sites?
What should be considered when engaging with a third-party service provider within the scope of trial product provision or home-care/nursing services?
Which documents can be submitted electronically signed?
Are electronically signed documents obtained from abroad valid?
Some of the authorized institutions in foreign countries running the apostille transactions suspended carrying out the activities. What should be done in this situation?
Can documents created in order to find volunteers (announcement, booklet, patient referral letter, etc.) be submitted during this period?
Are the compassionate use programs within the scope of the “Measures to be Taken in Clinical Trials Due to COVID-19 Pandemic”?
What should be done if the clinical trial is not displayed on the “Approved Trials” screen despite the first application made through Clinical Trial Module being approved?
3. Updates to the Guideline on the Clinical Trial Applications to the TMMDA and Guideline on the Clinical Trial Application to Ethics Committees
Within the scope of the Electronic Process Management Project of the TMMDA, the "Clinical Trial Module" was put into service on the 1st of December, 2019 in order to standardize clinical trial applications, ensure efficient time management and create an effective database. Following the launch of the Module, Guideline on the Clinical Trial Applications to the TMMDA and Guideline on the Clinical Trial Applications to Ethics Committees have been published on the 13th of November, 2019.
Upon the feedbacks received and assessments made, the abovementioned Guidelines have been updated on the 4th of December, 2020. Under the updated Guideline on the Clinical Trial Applications to the TMMDA;
Certain amendments on the filling method of the “Trial Detail” screen have been introduced;
Apostilled certificate/document of Good Manufacturing Practices has been counted among the required document to be submitted;
Instructions to follow in case of not being able to launch a clinical trial within 90 (ninety) days following the approval date have been specified.
Similarly, below amendments have been enacted on the Guideline on the Clinical Trial Applications to Ethics Committees;
Instructions to follow in case of not being able to launch a clinical trial within 90 (ninety) days following the approval date have been specified.
Published on Lexology on 27.01.2021