Regulatory Procedures

Last Updated on August 22, 2024

Regulatory procedures are the practices followed in accordance with laws and regulations. The Drug Regulatory Authority of Pakistan (DRAP) has published simplified regulatory process flows for pharmaceutical products, biological products, drug manufacturing licenses, clinical trial approvals, import and export procedures of therapeutic goods, and approval of advertisement of therapeutic goods. These simplified processes are aimed at enhancing the understanding of regulatory procedures for the industry and relevant stakeholders.

Please navigate to the concerned section to understand the relevant regulatory procedure and its process flow.

In collaboration with the Board of Investment (BOI) Pakistan, we have also developed a comprehensive knowledge hub for all regulatory processes. This hub provides extensive details on data and documentation requirements, explanations, regulatory fees for each process, and a section for frequently asked questions (FAQs). The knowledge hub also includes specific process flows for various departments, ensuring that stakeholders have access to clear and detailed information on regulatory procedures. This initiative aims to streamline regulatory compliance and support stakeholders in navigating the regulatory landscape more effective.