FDA..does every country has its own FDA -food and drug administration?

Question

hii there

Is US fda the only regulatory or each country has their own regulatory . And if a company outside usa produces a product ..does the company need to go to usfda or any other?

Answer 1

Yes countries have their own agency.   It's called different things like...Health Canada in Canada, Ministry of Health (MOH) in many S. American countries.  European Medicines Ageny (EMEA) in the European Union.  For clinical trials there is an set of rules called The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) which were agreed on by many countries so that when clinical trials are performed in one country other counties could be sure they were being performed a standard way.   Also trials can be done in multiple countries at the same time without having multiple sets of rules.  Data from an ICH trial can be used to support a license application in another ICH country.  However drugs are not going to be approved by the FDA unless some of the trials were performed in the US.  As for your second question if a company outside of the US has a product they want to market in the US they will need approval from the FDA.  If the company does not have offices in the US they will most likely license the product to a company already established here and let them handle the approval, manufacturing and marketing.

Answer 2

most countries have something similar to the FDA.

Products need to be approved by the authorities of every country in which it's marketed. However some co-operation between countries exists.