- Jan 9, 2022
Because US FDA is considered gold standard of certification. Without that you cannot export to North American market, and will have impact on even european market access.How the hell does US FDA have so much control over a foreign country's pharma factories? US is not even the biggest market out there.
FDA is most well funded drug regulatory agency in world. Not all chunnu munnu countries can afford to go and inspect every factory in some developing country, hence they refer to FDA report.