The Regulation Amending the Regulation on Manufacturing Plants of Medicinal Products for Human Use has been published in the Official Gazette dated 10 June 2022 and entered into force.
With the addition made to the Article 9 of the Regulation on Manufacturing Plants of Medicinal Products for Human Use within the scope of the amendment, it is stated that the Good Manufacturing Practices (“GMP”) inspections made by authorized other countries’ authorities or regional or international institutions and organizations with comparable standards would be deemed safe for the inspections to be conducted by Turkish Medicines and Medical Devices Agency for imported products
Within this framework, it is considered that GMP inspection processes and therefore medicines licensing process will become shorter. Details of the relevant topic will be made clear by the guideline that will be published.
You can access the relevant amendment from the link below (in Turkish):