Last Updated on November 5, 2024
Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to Clinical trials or bio equivalence centers/ studies and Advertisement of therapeutic goods.
1. Conduct of Clinical Trials and Bio-equivalence/ Bioavailability
Guidelines to Conduct Clinical Research in Pakistan
English ( 1.35 MB – PDF)
Guidance for Conduct and Reporting of Good Clinical Practice Inspection
English ( 1.35 MB – PDF)
2. Advertisement of Therapeutic Goods
Guidelines for Advertisement of Therapeutic Goods
English ( 510 KB – PDF)
Monitoring Advertisement of Therapeutic Goods
English ( 510 KB – PDF)
3. Rational Use of Drugs
Guidelines for Responsible Use of Antimicrobials
English ( 335 KB – PDF)
Guidelines on Standards for Establishment of Hospital Pharmacy in Pakistan
English ( 859 KB – PDF)
4. Ethical Marketing to Healthcare Professionals
Guidelines on Submission of Expenditure Details Under the Ethical Marketing to Healthcare Professionals Rules 2021
English ( 409 KB – PDF)
5. Reliance Mechanism
Reliance Mechanism in Regulatory processes, A DRAP’s approach on Good Reliance Practices
English ( 454 KB – PDF)