Abstract
Cooperation and harmonisation of standards in the pharmaceutical domain is already a reality and, in fact, has been increasingly important in recent decades. This harmonisation seems natural and logical in the current environment of increased globalisation imposed by the current geo-economic-political situation. However, even though this is a reality, it is important to analyse whether or not all stakeholders benefit from this increased cooperation and harmonisation, in order to recommend future actions or potential improvements. Cooperation, convergence and harmonisation is indeed not an end in itself. Elimination of differences, agreement on common standards and the increase of cooperation are needed to protect and promote global public health. It is therefore very important to thoroughly analyse the value and impact of the harmonisation and cooperation process, and to determine whether or not all the efforts made throughout the years have indeed met expectations. After many years of experience, it seems important to have a thorough evaluation to answer several important questions: ▸. What has been the benefit of the multiple harmonisation and cooperation initiatives so far? ▸. Should such processes continue? Are there any other alternatives to resolve current challenges? ▸. Should current initiatives and projects be improved? If so, how and what are the priorities? ▸. Would greater harmonisation and closer cooperation be beneficial? Is it possible? Is it necessary? What are the limits of this process? ▸. What are the important lessons from the past and the on-going harmonisation initiatives that should be considered for planning the next steps? This book section’s goal is to answer these important questions by thoroughly evaluating the added value of cooperation, convergence and harmonisation. This book section also reviews the critical parameters and influencing factors for cooperation, convergence and harmonisation. This review/analysis of critical parameters and influencing factors is essential to understand the complexity of the situation and effectively discuss how to organise the next steps of global cooperation.