The global perspectives in medicines development
The pharmaceutical industry is no longer solely
a national or even a regional business. Companies seek to market new medicines
worldwide. The costs of medicines development are tremendous. This means that
the industry wants to market on a global basis to ensure their return on
investment. To achieve this goal, only a limited time is available. After
patent expiry, other companies are allowed to market a generic product. For a
generic product there will be no need to demonstrate efficacy or safety in
extensive clinical trials. Generic medicines, accordingly, cost far less in
development and sell at a much lower price than the originator product (i.e.,
the product first authorised for marketing) and are therefore sometimes
preferred by a health system.
Medicines regulation differs between countries and regions. In case, the format and the requirements for application for marketing authorisation (MA) differ between countries, there is considerable extra effort and expenditure involved for the industry, as this means different MA applications would need to be prepared. Each national and regional regulatory authority may require different information in an application dossier. These individual and/or additional requirements will impact on industry and therefore also on patients and society as they drive up the cost and prolong the time of the medicines development.