Regulation for market registration

The key principle of a medicine assessment, performed by the regulatory authorities, is the balance between the benefits and risks of a medicine. The medicine should be safe, effective, and of good quality to be suitable for use in patients. A medicine will only be authorised if its benefits outweigh the risks. The application should, therefore, include information on:

• the pharmaceutical quality, including its chemical and physical properties
• the mechanism of action
• the distribution of the medicine
• the benefits for the patient group
• the safety of the medicine
• how risks will be managed and monitored

All experiments and studies should be performed in compliance with international requirements, such as good manufacturing, laboratory, and clinical practice. Which pre-clinical and clinical studies are necessary depends on the candidate medicinal product and the intended patient group for whom the medicine is developed. Therefore, it is important to know the guidelines before designing a development plan.