Regulatory Affairs (RA)
What are regulatory affairs (RA)?
Regulatory affairs is a profession dedicated to protecting public health by monitoring and controlling the safety and efficacy of pharmaceuticals and medical devices, or medtech. The companies responsible for discovering, testing, manufacturing, and marketing these products may also have RA professionals to ensure that they supply safe and beneficial products for public health.
Some of the tasks of regulatory affairs include:
- Advising on legal and scientific restraints and requirements
- Keeping track of the legislation in all regions where a company wishes to distribute its products
- Collect, collate, and evaluate scientific data
- Present registration documents to regulatory agencies and complete any necessary negotiations to obtain or maintain marketing authorization
- Help the company avoid problems due to inappropriate scientific thinking, poorly kept records, or poor data presentation
- Approve packaging and advertising before commercial use
- Reviewing applications for new drugs
Those who work in regulatory affairs follow the product through its entire lifecycle, from development to testing to post-market monitoring.
Why is RA important for healthcare?
RA is crucial in ensuring products and medical devices are safe and effective for public use. It is their job to submit registration documents and prove that the pharmaceutical or device meets the requirements necessary for market approval.