Pakistan

01/04/2023

Reliance Mechanism In Regulatory Processes "DRAP Approach on Good Reliance Practice". " This document aims to provide policy guidance to define criteria, procedures, and mechanisms for reliance pathways to facilitate regulatory decisions by giving significant weightage to the assessments performed by other National Regulatory Authorities or trusted institutions as a reference for various decision-making processes in regulatory functions performed by DRAP. "

02/27/2023

SRO 224(I)/2023: Notification of Amendment. Notification of Amendment in the Medical Devices Rules, 2017, dated 27th February 2023.

04/17/2023

Updates: Schedule of Charges; Regulatory Fees for Therapeutic Goods by Drug Regulatory Authority of Pakistan. The Drug Regulatory Authority of Pakistan (DRAP) issued a consolidated notification of Regulatory fees for various functions and services.

05/20/2022

Guidance on Clinical Trails Applications. This document is intended to provide general guidance to applicants in making new applications for clinical trials on therapeutic goods or any subsequent submissions to the Drug Regulatory Authority of Pakistan (DRAP).

04/30/2022

Imports & Exports of Therapeutic Goods. This document is applicable f for the import and export of therapeutic goods for commercial and non-commercial purposes.

How can RegDesk help?

RegDesk is an AI-powered Regulatory Information Management System (RIMS) designed to simplify global compliance for medical device companies. With regulatory intelligence covering 120+ markets, RegDesk helps you prepare and publish global submissions, manage standards, conduct impact assessments, and stay ahead of regulatory changes all from a single, centralized platform. Expanding into new markets has never been easier.