Last Updated on June 26, 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
2. Advertisement of Therapeutic Goods
![](https://i0.wp.com/www.dra.gov.pk/wp-content/uploads/2022/02/Guideline-Icon.png?resize=134%2C134&ssl=1)
Guidelines for Advertisement of Therapeutic Goods
English ( 510 KB – PDF)
![](https://i0.wp.com/www.dra.gov.pk/wp-content/uploads/2022/02/Guideline-Icon.png?resize=134%2C134&ssl=1)
Monitoring Advertisement of Therapeutic Goods
English ( 510 KB – PDF)
3. Rational Use of Drugs
![](https://i0.wp.com/www.dra.gov.pk/wp-content/uploads/2022/02/Guideline-Icon.png?resize=134%2C134&ssl=1)
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. Reliance Mechanism
![](https://i0.wp.com/www.dra.gov.pk/wp-content/uploads/2022/02/Guideline-Icon.png?resize=134%2C134&ssl=1)
Reliance Mechanism in Regulatory processes, A DRAP’s approach on Good Reliance Practices
English ( 454 KB – PDF)