Tricks executed to evade the obstacles set up by FDA for approval of drugs in China!

China holds substantial share in the healthcare market which is extremely crucial for overseas and multinational pharmaceutical companies. In the year of 2014, the aggregate cost of drugs in the Chinese healthcare market marked RMB 1332.6 billion. Drugs that have been imported by multinational companies contributed around a one fourth of the overall healthcare market in China. It has been speculated that in the year of 2015. The total cost of drugs in the healthcare market are predicted to be more than RMB 1559 billion. Forecast update suggests Chinese healthcare market will overtake Japan and turn into second biggest drug market economy after the United States. 

Although in the area of pharmacy stringent laws are being enforced for the sake of approval of drugs during clinical trials and drug registration quite well but are proving to be substantial obstacles to global pharmaceutical companies. So it is important to know what are those challenges are all about and how do they spoil business in China? What kinds of strategies are adopted by pharmaceutical companies to tackle these challenges? Overseas and multinational pharmaceutical companies are curious to know the answers behind these unsolved questions to manage and run their respective businesses without any problem in the Chinese market. 

In China, there are two primary strategies being followed to seek permission for registration about drug that is going to be imported. Thus, one of the commonly practiced strategy is overseas or multinational pharmaceutical producer conducts an international clinical trial in China which involves many surveys and controlled experiments. Once the trials are complete and the recommendation of imported drug registration is being forwarded along with examination result and approval of the FDA located in China then a drug will be conferred marketing authority in China and needs to be sold in the Chinese market only. 

In the past 10 years period some multinational companies utilized data provided by multi-center regional trials outside China to support their claim for an application of imported drug to seek permission for marketing purpose and to satisfy all the expectations and accomplish standards set by Chinese FDA to enter instantaneously into Chinese drug market. This technique is called as the quick access of Multi-Regional Clinical Trials, this is perhaps nicest option found by the groups of multinational pharmaceutical manufacturers to make submition of the application process more quick and result oriented to sell their imported drugs by getting registration number to have breakthrough in the Chinese market after fulfilling all the parameters of FDA.