International rules play a big role in how new drugs are developed and approved. These rules help make sure that drugs are safe, effective, and of good quality.

1. Approval Timeframes:

• On average, it takes about 12 to 15 months to get a new drug approved worldwide.
• In the U.S., most new drug applications (about 70%) are approved in under 10 months thanks to a special law that helps speed things up.

2. Organizations That Approve Drugs:

• In the United States, the FDA (Food and Drug Administration) is the main organization that looks at drugs.
• In Europe, this job is done by the EMA (European Medicines Agency).
• In Japan, there is the PMDA (Pharmaceuticals and Medical Devices Agency).

3. Requirements for Clinical Trials:

• Phase III trials usually need more than 300 people to take part.
• The information collected during these trials must follow strict rules called Good Clinical Practice (GCP).

4. Costs Involved:

• It costs, on average, around $2.6 billion to create a new drug.
• Before a drug can even be approved, it typically faces an average cost of $50 million just for meeting regulatory requirements.