Regulatory challenges in global pharmaceutical market lead to new drugs, and generics development to a large extent. There are too many similarities around the world concerning drug safety and availability. Differences and similarities in regulatory system and drug markets continue to significantly impact the firm’s strategy and the relative performance of pharma or biotechnology companies of different countries.
A report calculated that one third of new drugs were invented by Germany in the 1960s and 1970s. This figure dropped to 13 per cent in the 1990s and continued to decline with time. The US and Europe drug development rate has grown because of excellent innovation and regulations.
The new drug development as well as the generic drug availability is well balanced by the current regulations. The fundamental objective of the regulatory harmonisation is to improve the efficiency of national economics and their ability to adopt to change and remain competitive. The complicated regulatory landscape can be a barrier to success for foreign companies that do not have the experience or resources that are essential to overcome the obstacles in countries such as China, Japan, Korea, and Taiwan. Regulatory processes are also undergoing international harmonisation. As international market becomes more important, pharma companies will require greater cooperation among national regulators to get life saving drugs which will help them to market faster.
The Asia-Pacific region is one of the most vibrant and rapidly growing areas in the world. China is expected to become the fifth largest global pharma marketplace within the next few years. The environment surrounding the regulation of pharma products has shown steady improvement since the beginning of the new century, with significant changes over the last five years. These changes have brought greater transparency and professionalism to the regulatory arena, and increased the opportunities for the pharma industry to conduct clinical trials and introduce novel therapies.
However, major regulatory challenges remain for pharma companies looking to expand their clinical trial programmes into this region. Equally important, the challenges are different for each country. The Asia-Pacific region cannot be treated as a single market, but must be approached with an abundance of local knowledge. Success is contingent upon understanding the regulatory – as well as medical and social – nuances that characterise each country. With the right combination of local knowledge, perseverance, and flexibility, sponsors can overcome most of the challenges and take advantage of the opportunities to expand their clinical development programmes in this dynamic part of the world and reduce regulatory compliance costs.