Before a medication or new device for treatment of medical issues is available to the public, it must be reviewed by the Medicines Control Council (MCC) and an ethical committee, and approved for public use. The MCC does this to learn more about the product and make sure that it is effective and safe.
To get MCC and ethics approval, the company that makes the medication or device is required to conduct clinical research studies.
The companies ask people to volunteer for clinical research studies. In these studies, volunteers are given the investigational medication or device and are evaluated by study doctors and staff members.
After clinical research studies are completed, the pharmaceutical company submits the study information to the MCC. The MCC reviews this information and decides if the investigational medication or device can become available to the public.