The mandatory requirement imposed by the Turkish authorities for overseas manufacturers exporting pharmaceutical products to Turkey to obtain Good Manufacturing Practice (GMP) certification issued by the Turkish Ministry of Health is causing inordinate delays in the registration of new pharmaceutical products in Turkey. However, these delays can be resolved once the US Food and Drug Administration and European Medicines Agency start accepting Turkish GMP certificates, for which Turkey should obtain membership of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme.
Turkey offers six years of data exclusivity for innovator pharmaceutical products; however, this is limited by the patent protection term. Innovator pharmaceutical companies argue that data exclusivity and patent protection should be treated separately, which is not the case in Turkey, and they are also pushing for the commencement of regulatory data protection as soon as local regulatory approval is granted in Turkey.
TABLE OF CONTENTS
4 EXECUTIVE SUMMARY
5 DRUG APPROVAL PROCESSES
5 The General Directorate of Pharmaceuticals and Pharmacy is the key authority responsible for
new drug approvals in Turkey
6 Drug approval process in Turkey
13 INTELLECTUAL PROPERTY PROTECTION
13 Intellectual property bodies in Turkey
16 Data exclusivity
16 Drug counterfeiting
LIST OF FIGURES
5 Figure 1: Turkey – key authorities and their responsibilities
5 Figure 2: Organizational structure of the General Directorate of Pharmaceuticals and
7 Figure 3: Turkey – regulatory approval procedure
9 Figure 4: Regulatory approval procedure for generic drugs
13 Figure 5: Procedures for patent applications
14 Figure 6: Number of personnel and number of patent registrations at the TPE, 2006–12
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