Regulatory Systems and Policies


The objectives of WG2 are to examine how the existing national policies and regulations (for production,

quality control, and pharmacovigilence) conform to accepted international standards for best regulatory

practices and standards.

Key research questions:

1. What are the national regulatory systems for production, quality control, distribution and prescribing and

dispensing medicines for nationally produced and imported medicines?

2. How are these regulations developed, what are the enforcement mechanisms?