|
 |
Please use the register page of this website to submit any comments, questions or
suggestions about this site.
Question: What is regulatory
affairs?
Answer: In order for a health authority to
issue a marketing authorisation (licence), it must
communicate with regulatory affairs professionals
within pharmaceutical companies. The regulatory
affairs department within most companies will prepare
volumes of technical information, which has been
generated during the research and development phases
of the product for which the licence is being applied.
The technical information will include pharmaceutical,
toxicological and clinical data, which is assessed by
regulatory health authority experts in order to
ascertain safety, quality and efficacy of the product.
It is the responsibility of the regulatory
professionals to provide complete and accurate
information and to respond to any questions raised
during the assessment process.
Once a licence has been granted, the work of the
regulatory department does not stop as the licence
needs to be maintained to support its safe use
throughout its licensed period which is usually five
years, after which the licence will need to be
renewed. |
| |
| |
| |
|
