DATA REQUIRED FOR CTD APPLICATION

1. Applicant Information
2. DML & DSL
GENERAL 3. SECTION APPROVAL LETTER
INFORMATION 4. LAST CRF NOC
MODULE I 5. MANAGEMENT DETAIL
6. APPROVED TECHNICAL STAFF SIGNATURE AUTHENTICATION
7. E-APP ID & PASSWORD FOR E-FILLING

Raw Material Import Documents Like:

1. Name & Address Of API Manufacturer
2. API Import Clearance Documents
3. ADC NOC For API (Now PSSW Approval E-Prints)
DRUG SUBSTANCE 4. Nda Agreement B/W API Manufacturer and The Firm
5. COA Of API
DATA
6. 3 – COA Of The Same API With The Prior MFG Date Of The Purchased API MFG Date
(will be provided
7. MSDS Of The API
by the API 8. Other Import Documents Like Airway Bill Etc
Manufacturer) 9. DML Of API Manufacturer Along With Their Gmp Certificate
MODULE II For E.G Aarti Drugs India DML & GMP Certificate
10. DMF (Drug Master Formulary) W/C Will Be Provided By The API Manufacturer To The Firm
Purchasing Raw Material W/C Includes The Below-Mentioned Documents.
10.1. Stability Data On Zone Iv-A (Hot Humid/Tropical Zone)
10.2. Process Validation Data By The API Manufacturer
10.3. Analytical Method Validation By The API Manufacturer
10.4. Method Of Manufacturing
10.5. Characterization (Elucidation Of Structure And Other Characteristics (A) List
Of Studies Performed (E.G. Ir, Uv, Nmr, Ms, Elemental Analysis) And Conclusion From
The Studies (E.G. Whether Results Support The Proposed Structure):
10.6. Specifications
10.7. Justification Of Specification
10.8. Reference Standards Or Materials
10.9. Container Closure System (A) Description Of The Container Closure System(S)
For The Shipment And Storage Of The Drug Substance.
1 Description and Composition of the Drug Product
DRUG PRODUCT (a) Description of the Drug Product:
(b) Composition of the Drug Product: i. Composition, i.e. list of all components of the Drug
DATA
Product and their amounts on a per unit basis and percentage basis (including individual
(will be provided
components of mixtures prepared in-house (e.g. coating percentages s) and overages, if any
by the Firm
applying for (c) Description of accompanying reconstitution diluent(s), if applicable:
Registration of (d) Type of container closure system used for the Drug Product and accompanying
Product) reconstitution diluent, if applicable:

MODULE III 2. Analytical certificates (in-house) –COA of three batches of API along with the COA provided
by the drug substance manufacturer

3. Trial Batches BMR of atleast three batches of Drug product with following rules:
 a) ICH/WHO guidelines.
b) At least 2 batches having the following minimum batch size considering the scientific
reliability • OSDs : 5000 Units • Oral Liquid/Suspension : 2000 • Injectable : 2000 • Aerosol
and any other specialized preparations : 500
c) At least 3 batches having scientifically rational batch size, sufficient enough to perform
complete testing till the claimed shelf life.

4. Analytical method validation report (HPLC) of Drug Product

5. Pharmaceutical Equivalence Report of Drug Product with Reference/ ME-TOO Product.

6. Batch Analysis Reports

8. Reference Standard

9. Process validation

10. SOP regarding Batch Numbering system

11. SOP regarding stability protocol

12. SOP regarding In-Process controls

13. Blank BMR

14. Stability Data – Digital logger sheet

15. Chromatograms should be 21-CFR Compliant

16. Other Data is detailed below:

MODULE IV & V
OPTIONAL. Not Required

For More Information, please visit:

https://www.dra.gov.pk/wp-content/uploads/2022/01/Guidance-Document-on-CTD-Doc-No.-
PER-GL-AF-004.pdf