Masterarbeit

Dependencies between marketing authorisations in Developed and Emerging Markets – Implications for Regulatory Strategy ***

Svetlana Walter (2016)

Summary
Language: English
Global pharmaceutical companies striving to target their long-term strategy on emerging markets exclusively, often detect that a complete independence between the developed and emerging markets is not readily possible. This is due to the fact that medicinal products are often first authorised in developed markets (mostly Europe), followed by marketing authorisations in emerging markets, which forms a reference to the European medicinal products from the very beginning of the product lifecycle.
These so-called “reference licenses" are an important component of the marketing authorisations in emerging markets and can have a serious impact on the regulatory strategy of a company. Withdrawal or sale of marketing authorisations in developed markets, for example, would automatically result in a loss of the reference license, putting marketing authorisations in emerging markets at risk. Therefore, in order to achieve long-term independence of marketing authorisations between developed and emerging markets, various aspects must be considered in strategy setting.
Given the example of the current business separation activities at Abbott, this master thesis describes strategic and regulatory considerations to reduce the dependencies between marketing authorisations in developed and emerging markets, in particular in the Middle East, Africa and Eastern Europe, Caucasus and Central Asia (EECCA) regions.
The work related to this thesis includes data collected from interviews and experience of the Abbott regulatory offices in the respective regions, with regard to the communication with and the requirements of the concerned health authorities.
Pages: 53, Annexes: pages: 15