Recent Development The Turkish Medicines and Medical Devices Agency (“TITCK”) recently published on its website the Preparation Guidelines for the Turkish Pharmacopeia (“Guidelines“). Background Pharmacopoeia refers to a document containing national and international rules and methods that must be legally and scientifically complied with, including the physicochemical features of the active and inactive substances used in medicine production as well as the qualitative and quantitative analysis methods of such substances. The Guidelines aim to provide guidance for institutions, organizations, academics and others who submit information and documents for the development of methods, monographs, finished products and magisterial products for possible inclusion in the Turkish Pharmacopoeia in parallel with the EU Pharmacopoeia. |
The Guidelines introduce detailed rules on the establishment of pharmacopoeia working groups as well as technical requirements for the preparation of pharmacopoeia, such as form requirements for the development of monographs. The Guidelines are available here (in Turkish). The updated Guidelines entered into force on March 28, 2018. Conclusion The TİTCK continues to demonstrate its commitment to providing comprehensive guidelines for the pharmaceutical sector. Companies should take note of the Guidelines and take the necessary steps to ensure compliance. |
