اعتماد دلائل ارشادية لتحضير الملف الفني لتسجيل الأدوية

The Drug Technical Document covers all the Quality, Safety and Efficacy information of a drug in a common format called the Common Technical Document (CTD). It has revolutionized the regulatory review processes, led to harmonized submission enabling the implementation of good review practices. For the pharmaceutical industries, it has eliminated the need to reformat the information for submission to the different regulatory authorities.

To improve the review and evaluation of the Module 3 and Module 5 of the Drug Technical file, the MOPH drafted the following 3 Guides:

* Guideline for the Quality Module 3- Part S - Drug Substance- 2017
* Guideline for the Quality Module 3- Part P - Finished Product- 2017
* Guideline for Bioequivalence - Module 5- 2017