Module 7
Regulatory Strategy for Established Active Substances
Aim
The purpose of this Module is to enable students to study and understand the strategic issues to be considered in relation to medicines containing established active substances, including line extensions, generics and OTC products.
Learning outcomes
- Students will distinguish between the differing types of abridged applications possible in the EU and identify situations when the use of each of these is appropriate.
- Students will design and evaluate strategies for submissions in EU markets for products containing established active substances.
- Students will compare the routes to approval in the USA for products containing established active substances, sufficient to provide regulatory leadership to colleagues in this market.
Outline of Module topics
- The commercial importance of abridged applications
- The type and range of abridged applications in Europe
- The legal background to abridged applications including data protection, marketing exclusivity and patent protection
- Options for abridged applications, and use of the different regulatory procedures
- Strategy for abridged applications including implications for harmonisation of the SmPC
- Processing of abridged applications by the Regulatory Authorities
- Particular issues for products containing well-established active ingredients, generic and over-the-counter (OTC) products
- Routes to approval of products containing established active ingredients in the USA
