Last Updated on February 22, 2022
Drug Product Registration Application Types
Registration Board of DRAP under Section 7 of the Drugs Act, 1976 registers drugs (pharmaceuticals and biologicals) for human or veterinary use. Divisions of Pharmaceutical Evaluation & Registration and Biological Evaluation & Research of DRAP receive various types of applications for drug product registration as explained below. It is a pre-requisite to have a Drug Manufacturing License (DML) for manufacturers or Drug Sales License (DSL) for importers to apply for any of the following types of drug product registration.
![](https://i0.wp.com/www.dra.gov.pk/wp-content/uploads/2022/01/Reg_Types1-1.png?resize=720%2C405&ssl=1)
Forms required for application
Following are the regulatory forms required for applying for various type of drug product registration for human use:
S.No | Details | Application Form |
1 | New Drug / Molecule (local manufacture / import) | Form 5 F |
2 | Any other Drug for Import | Form 5 F |
3 | Locally manufactured drug with imported source of Half-Finished Products (Ready to Fill Bulk i.e., Pellets, Granules, etc) | Form 5 F |
4 | Generic Drugs (local manufacture) | Form 5 F |
5 | Drugs for Export Purpose | From 5 / 5A / 5D) |
6 | Drugs for export purpose on contract manufacturing basis. | Form 5 |
7 | Drugs for Export Purpose; where no generic product is available. | Form 5 D |
8 | Grant / extension of contract manufacturing permission | Form 5 F |
Requirements of Form 5 F (Common Technical Document)
Mandatory form for submission of registration application is Form 5 F. The requirements of Data submission on Form 5 F (Common Technical Document) under SRO 713(I)/2018 dated 08 June 2018 for registration of a pharmaceutical drug for human use are as follows:
Category | Module 1 | Module 2 | Module 3 | Module 4 | Module 5 |
New Drug Product | Yes | Yes | Yes | Yes | Yes |
Generic Drug Product | Yes | Yes Optional: 2.3.S.2.2 2.3.S.2.3 2.3.S.2.4 2.3.S.2.5 2.3.S.2.6 2.3.S.7.2 | Yes Optional: 3.2.S.2.2 3.2.S.2.3 3.2.S.2.4 3.2.S.2.5 3.2.S.2.6 3.2.S.7.2 3.2.R.3 | Yes Optional for approved drug products in the same combination, strength, and dosage form by reference regulatory authorities adapted by Registration Board. | Yes Optional for approved drug products in the same combination, strength, and dosage form by reference regulatory authorities adapted by Registration Board. |
Guidelines
Guidance document for submission of application on Form 5 F (CTD) for registration of drugs