Step 6

Official ok prior to launch

Every country has a special regulatory agency to check and monitor the safety and efficacy of medicinal products.

In Switzerland the regulatory agency is Swissmedic; for the EU countries it’s the EMA; and in the United States it’s the FDA, probably the best-known drug regulatory agency in the world. Most regulators also inspect the production plants for all drugs approved for marketing within their jurisdictions.

When a new drug is submitted for approval, regulators require comprehensive documentation. This usually fills hundreds of files, many of which have to be submitted in multiple copies.

It can take months to years for the authorities to complete their review.

During this time the drug maker and the authorities will be in regular contact with each other. A positive decision from a regulator means that the drug can be marketed within its jurisdiction.

Watch video on regulatory approval.