International Regulatory Affairs

For a drug to be marketed, it needs to have been tested and approved by drugs approval authorities. The approvals authority checks the risk-benefit ratio as part of the approval proceedings.

Only if the benefits of the drug outweigh its risks is an approval justified. The issuing of an approval certifies that the drug is marketable and can be launched on the market.

A substantial dossier on the drug is submitted with the application for approval. The documentation contains all the insights and results from the development that document the quality, effectiveness and safety of the drug.

The International Regulatory Affairs department has an important interface function between the pharmaceuticals company and the approval authorities. International Regulatory Affairs 'accompanies' the development of a drug, drafts the approval documentation and submits this to approval authorities around the world.

Furthermore International Regulatory Affairs also ensures, after the approval has been issued, that the latest official or statutory approval requirements are taken into account.