Research and Development Process of Health Products
The large population of our focused region consisting of people from different ethnicity, a variety of diseases, rare and genetic diseases which are often seen throughout the region, constitute essential advantages for the research and development (“R&D”) activities of health products. On the other, Turkey is an ideal location for the R&D activities with these particularities in the region. Besides, application for R&D activities is made online before the Turkish Medicines and Medical Devices Agency and concluded without any delay.
Regulations in Turkey that constitute the legal framework of R&D activities for pharmaceuticals, medical devices, and healthcare services are based on the European Union (“EU”) standards. R&D activities could be conducted in fully-fledged health institutions by experienced academicians, and specialist doctors, in conformity with the Good Clinical Practice (“GCP”) standards, with predictable and fewer costs in Turkey, comparing to the EU member countries. In addition to this, the Turkish State provides financial incentives for the R&D activities conducted in Turkey.
Within the framework of our activities, the entire R&D process to be conducted in the healthcare industry is carried out from beginning to end in Turkey.
Our primary activities in this context are as follows:
- Managing contract negotiation process in detail, with the health institution where the R&D activities will be carried out, forecasting all expenses which can be born along the process.
- Preparing a detailed financial plan in line with the contractual relationship established with the institution.
- Deciding on the laboratory with Good Laboratory Practices (GLP) System Certificate, where the animal experiments will be performed in the preclinical phase.
- Confirming whether animal experiments are performed in accordance with the Good Clinical Practice (GCP) standards or not.
- Preparing the research protocol for the product subject to the research.
- Filing a license application to enter into the clinical research process and, preparing a license application file to be submitted concurrently to the Turkish Medicines and Medical Drugs Agency and the Ethical Committee.
- Monitoring concurrent applications that have been made before the Turkish Medicines and Medical Devices Agency and Ethical Committee, informing the firm regarding the process on a regular basis.
- Examining regulatory compliance and ethical aspect of the provided financing to the clinical research.
- Obtaining permission for imported products to be used in clinical research.
- Lodging an application to the Turkish Medicines and Medical Devices Agency regarding any changes arisen which should be notified during the clinical research
- Issuing “Informed Volunteer Consent Forms” to be taken from experimental subjects in accordance with the legislation.
- Making the documents suitable for submission to the Turkish Medicines and Medical Devices Agency by providing notarized translations of the documents to be submitted to the institution which are issued in a foreign language other than English.
- Providing regulatory consultancy to ensure that human subject experiments are conducted in conformity with whole relevant legislation, particularly international agreements, GCP standards, and the applicable legislation in Turkey.