TURKEY

Regulatory and Ethical Procedures

The Regulation Relating to Drug Research of 1993 led to the establishment of Research Ethics Committees, and an administrative control was provided. This regulation is based on the Declaration of Helsinki and the Turkish Medical Ethics Regulation of 1960. Furthermore, a circular of the Drug and Pharmacy Department of the Ministry of Health of 1995 underlines the importance of ethical principles and compliance with ethical rules and Good Clinical Practice. Local Ethics Committees, set up in health institutions, examine and evaluate clinical trial protocols and send them to the Ministry of Health within one month if approved. The Central Ethics Committee, set up in the Ministry of Health, reviews the documents submitted by the Local Ethics Committees, examines the research proposals and gives an opinion within two months. Turkey bringing pharma laws into line with EU Early 2004 the Turkish government has implemented a number of regulations and issued more for consultation as part of a drive to bring its pharmaceutical laws into line with those in the EU. Health Care System Health services are provided mainly by the Ministry of Health, the Social Insurance Organisation, universities, the Ministry of Defence, and private health facilities. The majority of the population is covered by the social insurance system. In the past few years there has been a substantial increase in the number of people covered by private health insurance. The government (assisted by the World Bank) has a health reform programme aimed at expanding health insurance to cover those lacking insurance coverage. The health reform projects also include establishing a family physician system, reforming hospital care, and improving the quality of health care particularly in the poorer rural and eastern parts of the country. Why Turkey? Huge potential in all aspects of - Patients - Indications (rare diseases) - Experienced investigators - Site staff with expertise in GCP - Fully equipped hospitals - Accredited laboratories according to international standards Cost sensitive services Why with ECRON? Expertise on local regulations and laws Experienced, dedicated team Broad range of therapeutic area experience Excellent communication with opinion leaders Smooth relations with LEC and regulatory authority Authorities Ministry of Health