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.
2.7 Clinical Summary.
-Biopharmaceutic Studies and Associated Analytical Methods.
-Clinical Pharmacology Studies.
- 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.