Question

Can someone please give and explain 3 elements that define Pharmaceutical world as highly regulated.

Answer 1

Ans - State Regulatory Infrastructure, Monitoring the Private Market and Public Quality Control. Identifying the different variables that affect a state’s institutional capacity and current standard level offers new insights to the state of pharmaceuticals in the developing world.Countries possess their own regulatory authority, which is responsible for enforcing the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing, labeling and the product life cycle of pharmaceutical products. In an ever-changing regulatory environment, the role of regulatory affairs personnel is essential to ensure compliance with legislation in all regions in which a company wishes to distribute its drug