Regulatory Affairs
Fast authority approvals for new products and changes to our existing portfolio
Regulatory Affairs ensures availability of high quality therapies to patients all over the world through rapid approvals of all Novo Nordisk’s products in the nearly 200 markets in which we operate.
We lead and support the processes around all authorisation applications and renewals. We give the company access to the marketplace by ensuring that we have sufficient documentation for licensing of our products and by developing scenarios for strategic decisions. We aim to proactively spot opportunities and engage in dialogue around guidelines that set barriers for marketing of Novo Nordisk’s products.
Regulatory Affairs is a fast-changing field and the 400+ dedicated employees worldwide possess negotiating skills, as well as scientific insight and serve as Novo Nordisk’s representatives around the world. We strive to be responsive to the business needs of the company and we work closely with authorities and partners within Novo Nordisk to be able to navigate through the complex regulatory environment.
A constantly changing field
In 1954, we submitted a seven pages application approval of three new products.
In 2008, we submitted the liraglutide application to the FDA electronically. As a consequence of carefully planned regulatory strategy and massive data requirements, it encompassed 930.000 pages.
A printout of the application would be as high as 116 meters – about one third of the height of Empire State Building.
