Module 18 2021

07/02/2021

CONDITIONAL MARKETING AUTHORISATIONS  Special authorisation: ● Designed to speed up access to medicines for patients with unmet needs. ● Renewed annually ● Authorised prior to completion of Phase III studies  Since 2006 ● Over 40 products approved on this basis – Including for HIV infection, breast cancer, severe epilepsy in infants

and multi-drug resistant tuberculosis – Almost half were orphan medicines

The Organisation for Professionals in Regulatory Affairs

19

What is the Marketing Authorisation?

 A COMMITMENT to manufacture, sell and supply a drug product in accordance with evidence provided on its: ● QUALITY ● SAFETY ● EFFICACY

The Organisation for Professionals in Regulatory Affairs

20

10