STEFANIE LIETSCH-DALLWIG
Senior Director Global Program Management – Service Solution Lead Local Affiliate Services, PharmaLex

Abstract

The global pharmaceutical industry must navigate a rapidly evolving regulatory environment, where, despite harmonisation efforts, significant regional or country differences remain. This places huge pressure on the local affiliate model, as Stefanie Lietsch-Dallwig explains.

Globalisation is well-entrenched in the pharmaceutical industry. Companies of all sizes are increasingly looking beyond their own regions to market their products. Indeed, today, a typical large pharmaceutical company may have 100 or so operating companies or affiliates worldwide. Furthermore, manufacturing facilities can now be found in more than 150 countries, underscoring the global nature of the industry (1).

While Europe and North America combined account for nearly 75% of the global market, rapid growth in several key emerging markets means industry must ensure broad and deep global reach – and with it, the often widely diverging knowledge and expertise of all the markets in which they operate (2).

Even within the European Union, where the European Medicines Agency’s centralised procedure gives companies a single marketing authorisation for approved products (3) country-level regulatory professionals have found safety, quality as well as administrative and technology differences remain.

Further exacerbating the challenge is the fact that regulations have become more stringent and have changed rapidly ...