General

Due to unavoidable issues in internet services, you may face trouble or unavailability of online systems until the issue is resolved.

Strategic Plan sets ambitions for us to achieve our strategic objectives that contribute towards ensuring availability of quality assured, safe and effective Therapeutic Goods (TGs) in Pakistan. We are committed to maximize opportunities of treatment for patients for the people of Pakistan.

Our Strategic planning is based our vision of enhancing Access to Medicine for all by contributing to advancement in the health care regulations in Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) is striving to fulfill its mission of ensuring the availability of safe, effective, and quality therapeutic goods through a transparent and efficient regulatory framework. In line with the Government’s “Digital Pakistan” vision, DRAP has successfully digitized all regulatory functions related to pharmaceuticals, biological drugs, and medical devices, streamlining processes to foster an environment conducive to the ease of doing business. The Alternative Medicine & Health Products online system will also be launched soon.

To facilitate stakeholders in navigating these digital advancements, the following key initiatives and directives are brought to your immediate attention:

1. Comprehensive video tutorials and step-by-step user guides are available on the official DRAP website to assist stakeholders/applicants in navigating these online portals.
2. To ensure clarity and regulatory predictability, DRAP has published detailed guidelines for various regulatory processes, ensuring that requirements are transparent and accessible to all.
3. A Case Management System has been launched to streamline regulatory correspondence and planning of regulatory interactions, when required.

While DRAP has made every effort to simplify the regulatory interface, it has been observed that some stakeholders continue to rely on third-party consultancy services for processing their applications. DRAP strongly discourages the direct engagement of unauthorized consultants. Stakeholders are advised that the use of intermediaries can lead to complications regarding accountability and data integrity.

To safeguard your legitimate rights and business interests, please adhere to the following security protocols:

1. Ensure that all login credentials for DRAP’s online platforms are kept secure and under the direct control of your authorized company personnel.
2. Strictly limit or restrict access of outside consultants to your digital portals to prevent unauthorized data manipulation or privacy breaches.
3. Regularly visit DRAP’s official website for regulatory updates and notifications.

The digitization of DRAP is intended to empower stakeholders by providing a direct and transparent link to the regulator. DRAP is actively collaborating with trade associations and health partners to conduct specialized training sessions. These programs are designed to promote a culture of compliance across the industry and to gather direct user feedback to continuously refine and improve the online systems. DRAP remains your partner in progress, committed to continuous improvement through direct engagement and technological innovation.