Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Maintenance of Marketing Authorizations of Medicinal Products in the MENA Region – Differences and Similarities to European Procedures ***

Zohaira El Malahi (Abschlußjahr: 2018)

Summary
Language: English
In the last years, the MENA region becomes one of the “emerging” markets in the pharmaceutical sector in the world. The importance of this region for many multinational pharmaceutical companies is very high. This is due to the growth of the population, the increasing affluence and the increase of life expectancy. Inside the region, the tendency of the increased numbers of MAH and manufactures increased since several is still ongoing and the authorities are developing and modifying new regulations and laws in order to justify this development.
The importance of marketing authorizations of medicinal products is not only limited in the approval of new marketing authorization. It is more important to maintain existing marketing authorizations in these countries to ensure the prevention, diagnosis and treatment of diseases and for patient rehabilitation.
Even the developing process of adequate regulations for medicinal products is still ongoing, in most of the MENA countries there are a lots of challenges. Many of the regulations are only available in Arabic. For the Maghreb States the submission dossier has to be provided in French. Additionally the political situation in some MENA country is not stabile and the processes are not transparent enough. These barriers complicate the authorization and maintenance for medicinal products in the MENA region. Finally the population has to face up with the consequence of these barriers.
This master thesis will provide an overview about the maintenance procedures for marketing authorizations in the MENA region and to compare them with the European procedure. This comparison conveys how far the development of the pharmaceutical sector in the MENA region is in opposite to Europe and how the trend will develop in the next years.
Pages: 60, Annex: 86