Last Updated on May 11, 2023
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
Guidance on Clinical Trials Applications-For Applicants
English ( 750 KB – PDF)
Guidance on GCP Compliance Inspection
English ( 276KB – 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)
4. Reliance Mechanism
Reliance Mechanism in Regulatory processes, A DRAP’s approach on Good Reliance Practices
English ( 454 KB – PDF)