Regulatory Fees

Last Updated on October 25, 2022

The Drug Regulatory Authority of Pakistan (DRAP) charges fees for various regulatory functions and services its provides. These regulatory fees and charges are defined under relative legal statutes of the therapeutic goods regulation.

Following is the guidance on applicable fee for various regulatory functions and services provided by the DRAP in accordance to the under Section 7(n) of DRAP Act, 2012.

Schedule of Charges ; Regulatory Fees for Therapeutic Goods by Drug Regulatory Authority of Pakistan
English ( 326 KB – PDF)

Note. This guidance document does not provide an exhaustive list of all regulatory functions being performed by the DRAP, as some regulatory functions and services are being carried out without any charges / fee. Similarly, the relevant legislative statute may be referred to for exact wordings of applicable fees, where necessary.

How to Pay Regulatory Fee?

DRAP has introduced an online fee challan system to facilitate the therapeutic goods industry. The applicant is required to first register in this system using any of following information :

  • Drug Manufacturing license (DML);
  • Drug Sale license (DSL);
  • Establishment License;
  • Establishment Enlistment number.

Once the account is created, this system will help user in the selection of applicable regulatory fee for the required service(s) under the respective regulatory function. The applicant can generate the fee challan(s) for any required purpose. The applicant must ensure that the correct fee challan is generated.

What services of DRAP are free?

DRAP is not charging any fee for following public services:

  1. Issuance of Personal Based NOC for Import or Export of a therapeutic goods (For applying go to Personal Use online services)
  2. Issuance of NOC to import donations