Manuals & Guidelines
Guidelines for the Drug Technical File Submission: Module 3 (S and P Parts) and Module 5 (Bioequivalence Study)
Author: Dr. Rita Karam & Technical Subcommittee’s Experts
Source: MOPH
Source: MOPH
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
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
These Guides are prepared by scientific experts and are intended to provide guidance and requirements for the preparation of the technical file to be submitted to the MOPH Technical Committee of Drugs. They are based on ICH standards and are useful for the Applicants of Generic Drug Technical file.
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