NEWSLETTER-2017

390 NEWSLETTER 2017 in the Turkish pharmaceutical sector, 56 of which are local firms, and 71 are also engaged in drug production 10 . The pharmaceutical sector is an intensively regulated sector, both globally and nationally. Licens- ing and repayment systems are examples of regulations to which this sector is subject 11 . Licensing Process The main duty of the regulatory bodies and authorities in the pharmaceutical sector (which is directly related to public health) is to analyze the reliability of the drugs, subject to approval in terms of their effectiveness and quality, and to ensure that they are accurately licensed. Following scientific research and development activities, before a newly developed drug is offered to the market, approval from all of the different authorized regulatory bodies in the pharmaceutical sector must be obtained. In Turkey, the ministry authorized for the licensing of drugs is the Ministry of Health (“Ministry”). More specifically, the Turkish Drug and Medical Devices Administration is authorized for the determina- tion and application of the rules and standards for licensing, storage, sales, import, export, market supply, distribution, putting into service, withdrawal and use of drugs 12 . Licensing of drugs was initially regulated in Turkey by the Pharmaceuticals and Medical Preparations Law 13 in 1928. Licensing of drugs are completed according to the Regulation Regarding the Licensing of Human Medicinal Products 14 which entered into force 10 İş Bankası Pharma 2016/1 Report, https://ekonomi.isbank.com.tr/UserFiles/pdf/ sr201601_ilacsektoru.pdf (“ İş Bankası ”). 11 İş Bankası. 12 Article. 27, Statutory Decree Regarding the Structure and Duties of Ministry of Health and Related Institutions ( Sağlık Bakanlığı Ve Bağlı Kuruluşlarının Teşkilat Ve Görevleri Hakkında Kanun Hükmünde Kararname ), Decree No: KHK/663, published on the Official Gazette dated 2 November 2011 - Number: 28103. 13 Law No: 1262 Regarding Pharmaceutical and Medical Products (*) Enactment Date: 14 May 1928 published on the Official Gazette dated 26 May 1928 and numbered 898. 14 Regulation on Licensing of Human Medical Products by Ministry of Health pub- lished on the Official Gazette dated 19 January 2005 and numbered 25705 (“ Reg- ulation ”).