Drug Registration Process In the USA

Drug Registration Process In the USA

The United States represents the largest continental pharma market worldwide and holds around 45% global market. The pharmaceutical market in the United States was expected to increase from $354bn in 2015 to $497bn by 2020. The FDA is the main regulatory body that handles drug approval in the United States.

Though markets like China and India have shown a massive leap in the pharma market, the United States and Europe are still the key players in the pharmaceutical industry.

The United States has the world’s most stringent standards for approving drugs, and drug approval standards are considered the benchmark by many regulators worldwide.

You need to know the following to register a drug in the United States

  • What are the different categories of drug applications in the USA?
  • Which category does a specific product belong to?
  • What are the documents required to register the specific category of drugs?
  • How about clinical trial data requirements and clinical study waivers in various circumstances?
  • Who can register the medical products in the USA and/or hold the marketing authorization for a specific drug in the USA?
  • What is the overall process applicable for registering specific drugs in the USA?

Get Complete Details on Regulatory, Requirements, and Process for Registering Pharmaceuticals in the USA.

Credevo has prepared this report by collecting the relevant information as per the current understanding and awareness of Credevo. Click on the blue button below to download the report.

Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for registering pharmaceuticals in the USA. While the report can be considered as an informative resource, it is not being presented as legal guidance, a binding document, or any authoritative report. The information in this report was prepared based on relevant information from the public domain as of the date, however, the regulations and requirements may change with time and it is advisable to refer to current regulations at any given time. It is recommended to confirm the specific details, requirements, and processes applicable to your specific products at a given time before initiating any process of registration.