What are variations in regulatory affairs?

Variations are all the changes made in the dossier of an authorised product after
its initial registration. They may concern administrative changes, Quality changes,
Safety/Efficacy changes or Vigilance changes.
Prior to the phase 4 trial
In phase 1 clinical trials, the safety, tolerability and toxicity of the drug at different doses
is tested in a small number of healthy volunteers. In phase 2, the drug's efficacy and
optimal dosing regimen are established.

After phase 2, the drug enters the most vital stage of its development, the phase 3 trial.
This is the last phase of testing the drug needs to complete before the drug information
and clinical trial results are submitted to the regulatory authorities for approval of the
drug for use in the general population.

Phase 4 trial
The phase 4 trial is also referred to as post marketing surveillance and as the name
suggests, it is conducted after the drug is already marketed and available to the general
public. The main objective of the phase 4 trial is to check the drug's performance in real
life scenarios, to study the long-term risks and benefits of using the drug and to discover
any rare side effects.

The change control process is a set of coordinated activities through which the desired
change is implemented in an existing function, process, or product in the pharmaceutical
industry.