| Abstract | The pharmaceutical business of today is a complex interplay between the pharmaceutical industry (manufacturers), pharmaceutical research, pharmaceutical technology, regulatory environment and market demographics. In order to have innovation medicine available as soon as possible, the company needs to understand very clearly the requirement from each country, each region to ensure that the time to the market of new medicine, especially innovation medicine is the shortest. This is reason why Regulatory and Medical Affairs, a bridge between industry and Regulatory Agency plays as a very important key for the success of Pharmaceutical business.
Getting the approval for new registration in Vietnam is more complexity compared with other developed countries in the world and the region and leads a pharmaceutical company operating in Vietnam is facing with very critical task: getting new registration.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, how to shortness the time for getting the registration number means, how to have the shortness time to the market in every country of a new medicine is very important because it direct effects to the Bayer Schering Pharma business. Vietnam market is not an exception.
With the purpose of implementation “project 30+” in Vietnam, the roles and responsibilities of regulatory and medical affairs department becomes more important and challenge because improving performance of regulatory and medical affairs department is only the way to have more and sufficient products for selling in the market. |