Regulatory authority

In Regulatory & approvals

Also known as: competent authority, health authority, FDA, EMA, MHRA

A regulatory authority is the government body that authorizes trials and approves medicines in its territory. Examples include the FDA in the United States, the EMA and national authorities in Europe, the MHRA in the United Kingdom, the PMDA in Japan, and CDSCO in India. Their requirements overlap heavily thanks to ICH, but each has its own procedures and timelines.

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Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.