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Drug Regulatory Affairs

Drug Regulatory Affairs in Pharma Industry plays 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 last stage of Product Preparation & distribution like after complete & successful manufacturing, packaging & incorporation for stability of  Validation batches.main role of DRA department is act as mediator in between Regulatory authority & Manufacturer of Pharmaceutical products. DRA mainly works on eCTD, CTD, ACTD, Clinical studies, Non- Clinical Studies. now days 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;

ORGANISATION OF THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

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.

-Pharmacology.

-Pharmacokinetics.

-Toxicology.

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.