Drug Regulatory Affairs

Drug Regulatory Affairs

Drug Regulatory Affairs in Pharma Industry plays an important role as all departments of Pharma product Manufacturing Like Quality Assurance, Quality Control, Production, Microbiology also same as Formulation & Development Department & Analytical Development Department.

Drug Regulatory Affairs comes in the last stage of Product Preparation & distribution like after complete & successful manufacturing, packaging & incorporation for the stability of  Validation batches. the main role of the DRA department is acting as the mediator in between Regulatory authority & Manufacturer of Pharmaceutical products. DRA mainly works on eCTD, CTD, ACTD, Clinical studies, Non- Clinical Studies. nowadays DRA works on ICH guideline M4: The Common Technical Document.

As per ICH  Organisation of  The Common Technical Document for the Registration of Pharmaceuticals for Human use should be as per given below;


Module 1: Administrative Information and Prescribing Information.


1.1 Table of Contents of the Submission Including Module 1.

1.2 Documents Specific to Each Region (for example, application forms, prescribing information).

Module 2: Common Technical Document Summaries.


2.1 Common Technical Document Table of Contents (Modules 2-5).

2.2 CTD Introduction.

2.3 Quality Overall Summary.

2.4 Nonclinical Overview.

2.5 Clinical Overview.

2.6 Nonclinical Written and Tabulated Summaries.




2.7 Clinical Summary.

-Biopharmaceutic Studies and Associated Analytical Methods.

-Clinical Pharmacology Studies.

-Clinical Efficacy.

-Clinical Safety.

  • Literature References.

-Synopses of Individual Studies.

Module 3: Quality.


3.1 Table of Contents of Module 3.

3.2 Body of Data.

3.3 Literature References.

Module 4: Nonclinical Study Reports.


4.1 Table of Contents of Module 4.

4.2 Study Reports.

4.3 Literature References.

Module 5: Clinical Study Reports.


5.1 Table of Contents of Module 5.

5.2 Tabular Listing of All Clinical Studies.

5.3 Clinical Study Reports.

5.4 Literature References.

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