Understanding Regulatory Agencies Involved in Drug Development

Drug development is highly regulated at a country specific level.  Here are some of the common acronyms and definitions we use in the pharma industry related to regulatory agencies.

FDA = Food & Drug Administration – the United States regulatory agency that oversees drug development and approval (in addition to many other products such as cosmetics, food and medical devices)

IND = Investigational New Drug application – to begin human trials of an investigational drug, in the U.S. an IND is required.  The clearance of an IND requires appropriate non-clinical safety data amongst other requirements including data related to the manufacturing of the clinical trial material to be studied.

NDA = New Drug Application – this is the application required by a sponsor to request that FDA formally approve a drug for marketing and sale in the United States.  This documentation includes data to support the safety and effectiveness of a therapy, the potency and purity of the product and appropriate labeling. 

EMA = European Medicines Agency – the FDA equivalent in Europe; the agency that oversees drug development in the European Union.  In Europe, it is a little more complex because drug approvals are at the level of the EMA whereas, the ability to initiate clinical trials with an investigational drug can occur at the country level.

CTA = Clinical Trial Application – submission to the regulatory agency of a specific country (competent National Regulatory Authority) to conduct a clinical trial in that country

PMDA = Pharmaceuticals and Medical Devices Agency – this is the FDA and EMA equivalent in Japan.

In South America, individual country regulatory agencies oversee drug development and approvals.  

Every regulatory agency has different rules and regulations governing clinical trials and drug approvals for marketing and sale.  The functional experts within a pharma/biotech company that are charged with understanding these processes and regulations are called “Regulatory”. Regulatory personnel can have a varied educational background including: pharmacists, science degrees, business.