Thursday, May 21, 2015

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. 

Tuesday, May 12, 2015

USA presses Greece to deny Turkish pipeline project for its own benefit.

Washington is insisting Athens not to disown an extended support by western to Trans Adriatic Pipeline project for the sake of Russia recommended Turkish stream, it is basically a pipeline that will help Europe to source Russian Oil and Gas via Greece. Now it is depend on the mercy of Greece whether to consider and sanction this project which will enrich Europe with natural gas supplies from Azerbaijan through the passage of Turkey, Greece, Albania and the Adriatic Sea, this information has been revealed by the top US energy diplomat Amos Hochstein after important dialogue with Greek officials.

“Turkey Oil and Gas is not a part of this discussion. There is no association or body to build it and till date there no agreement has been signed to build it. Thus, do not involve Turkey into this proposal and wait until there is some visible change in the situation and we shall check whether that is applicable or irrelevant and mean while let’s pay attention on what is important. The pipeline about which we are keen have been agreed to term by the Greece and Washington”, Hochstein emphasized. He didn’t provide any crucial ingredient of the meeting with Greek officials and just went on saying more about what they agreed on.” Panagiotis Lafazanis is a Greek Energy Minister who said that the country will continue to support the Russian gas pipeline project. “We are going to participate in this project because we believe that it will be beneficial for our country”.