Importance of Guidelines in Regulatory Toxicity studies Guidelines are the consensus document accepted by a regulatory body Prevent duplication of clinical trials in humans Ensure SAFETY, EFFICACY and QUALITY of medicines Minimize the use of animal testing without compromising safety and effectiveness

1. Importance of Guidelines in Regulatory
Toxicity studies
Chander K Negi
M.S Pharm, Regulatory Toxicology
National Institute of Pharmaceutical
Education and Research, S.A.S.
Nagar, Punjab-160062
chandernegi09@gmail.com

2. Guidelines are the consensus
document accepted by a regulatory
body

3. REGULATORY AGENCIES
■ ICH
■ OECD
■ FDA
■ WHO

4. NEED OF GUIDELINES

5. ■ Prevent duplication of clinical trials
in humans
■ Ensure SAFETY, EFFICACY and
QUALITY of medicines
■ Minimize the use of animal testing
without compromising safety and
effectiveness

6. ■ Provides the definite parameters of
evaluation
■ Provides a roadmap to prepare a study
protocol
■ Increase international harmonization of
technical requirements to ensure that
safe, effective, and high quality
medicines are developed and registered
in the most efficient and cost effective
manner

7. ■ Supports economic growth, raise
living standards, maintain financial
stability and contribute to growth in
world trade
■ Regulation of biocides – OECD
biocide programme aims to attain a
harmonized approach in the
regulation of biocides

8. ■ Assessment of chemicals- harmonized
activities concerning new chemical to
reduce work of government and cost of
industry
■ Chemical testing guidelines- most
relevant internationally agreed method
used by government, industry and
independent laboratories to assess safety
of chemical products

9. Thank You