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THE GOOD REGULATORY PRACTICES GUIDELINE FROM THE TMMDA


The Turkish Medicines and Medical Devices Agency (“TMMDA”), has declared on 11 May 2022 by the announcement provided on its website that the Good Regulatory Practices Guideline (“Guideline”) has been published.


The purpose of the Guideline is stated as to explain the merits of execution of regulatory proceedings carried out by TMMDA during the fulfillment of its duties, powers and responsibilities. In this direction, the below principles are determined as the Principles of Good Regulatory Practices:

· Legality

· Consistency

· Independence

· Impartiality

· Proportionality

· Flexibility

· Clarity

· Efficiency

· Transparency


With the publication of the Guideline, parallelism with the World Health Organization Good Regulatory Practices Guideline, which was published last year and covers the same principles, has been ensured as well.


You can access the Guideline from the link below (in Turkish):

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