ABSTRACT
The end of the twentieth century has been characterized by a global approach by all types of industry. The conquest of the world market became the objective and companies, including pharmaceutical firms, considered mergers the way to achieve this goal. The ever growing companies are facing new types of challenges linked to their decision to go global, i.e., to work at an internationallevel. Some companies became real dinosaurs and risk extinction because they are no more flexible and cannot adapt to changing conditions as fast as their competitors. Some have realized that "small is beautiful" and look more into the area of codevelopment, comarketing, and small acquisitions, maintaining the entities separately, to keep their flexibility. Whatever approach has been opted for, globalization is also taking place at the level of the consumers and at the level of the authorities and organizations such as the World Health Organization (WHO), that want to protect the citizens, wherever located. Standards drafted by some regions become worldwide standards almost simultaneously or not long thereafter because human beings deserve respect everywhere, whether they live in skyscrapers or huts,
whether they risk dying from overeating or starvation. The pharmaceutical industry is facing the incredible challenges of the next millennium in the same way as other industries. The shrinking of the globe due to highly increased and fast transport and communication means has completely changed the conditions for industry. Evaluation of the immediate potential market is not the only factor determining the type of medicinal products that should be developed. Products to prevent and cure diseases in both the Northern and Southern Hemisphere are now a prerequisite for the pipelines of pharmaceutical companies. This means that clinical trials are not limited to some regions in the world, and that data collected elsewhere in the world need to be acceptable as part of submissions to regulatory authorities worldwide.
