Clinical drug evaluation: the regulatory perspectives

Area of Science:

• Pharmacology
• Regulatory Science
• Health Policy

Background:

• Discusses the regulatory framework for clinical drug evaluation in Singapore.
• Highlights the role of the Centre for Drug Evaluation.
• Compares Singapore's system with those in developed countries.

Purpose of the Study:

• To examine the regulatory perspectives of clinical drug evaluation.
• To analyze benefit-risk assessments for new drugs.
• To explore international harmonization in drug evaluation.

Main Methods:

• Review of regulatory documents and guidelines.
• Comparative analysis of international drug evaluation systems.
• Discussion of benefit-risk assessment principles.

Main Results:

• Implications of Singapore's Medicines (Clinical Trial) (Amendment) Regulations 1998 and Good Clinical Practice Guidelines analyzed.
• Exploration of international harmonization through the International Conference on Harmonisation.

Conclusions:

• Developing drug evaluation capability is crucial for Singapore's knowledge-based economy.
• Investigator understanding of clinical drug evaluation and regulatory aspects is vital for better clinical trials.