Regulatory Authority or Health Authority?

This post was originally published at www.regulatorybuddy.com

After I started working in Regulatory Affairs, I started noticing that we use regulatory authority and health authority interchangeably when talking about organizations such as FDA, Health Canada or MHRA (the organizations to which we generally submit drug applications for various purposes).

What is the difference between both terms? Can we really use them interchangeably? Is there a time when we should specifically use “Health Authority”?

Regulatory Authority is a government agency that regulates businesses in the public interest. In other words, it is an administrative body of government with administrative responsibilities towards its public. Regulatory Authorities define regulations. Regulation is a rule or order telling how something is to be done. In general, whether we know it or not, regulations have an impact in our daily life. They are not specific to a single Industry. Industries such as health care (Pharma/Biotech), finance, utilities, banking are regulated industries. And each industry is regulated by one or more regulatory authorities. For example, within US, Federal Deposit Insurance Corporation (FDIC) and Federal Reserve Board regulates Banks; FDA regulates Food and Drugs.

Because the products of Pharma/Biotech field impact public health, we are governed by regulations related to health. Hence, we use regulatory authority or health authority within the industry interchangeably. All health authorities are regulatory authorities but not all regulatory authorities are health authorities. Within our Industry, it is ok to use Health Authority or FDA or Regulatory Authority interchangeably. But you may not be talking about the same agency or authority if you are in a group that has people from different industries.

In a room full of people with different industries, if it every happens, better use the term “Health Authority” or specific agency (such as FDA) to refer to FDA.