Innovative Drugs and Anti-Cancer Compounds Are Most Welcome in the Chinese Market, Says Asia-Pacific CRO George Clinical
BEIJING, May 9, 2018 (Newswire.com) - In another encouraging step towards securing China as a leading destination for clinical drug trials, a number of critical developments were announced by Chinese Premier Li Keqiang at The Executive Meeting of the State Council on the 12 April 2018.
The Executive Meeting of the State Council announced that from 1 May 2018, the import tariff of all "common drugs" including anticancer drugs, alkaloids with anticancer effects and the imported patented Chinese medicines will be reduced to zero. There will also be a "large reduction" in the value-added tax (VAT) applied to the production and import of anti-cancer drugs. This change will have a significant positive impact on the budgetary considerations of sponsors considering, or already scheduling, a trial in China.
There is a remarkable push by the Government to make sure that China is at the forefront of R&D globally. With this dynamism, there is an opportunity!
Philip Gregory, Managing Director of George Clinical
Secondly, in an effort to speed up the development of innovative drugs, the clinical trial application will change from the standard approval process to the default approval, similar to that implemented through the FDA IND mechanism. The result of this will mean that Imported chemical drugs can be cleared according to the examination results of enterprises, instead of compulsory batch custom examinations – speeding up timelines and again have a positive impact on a sponsor's bottom line.
Finally, to strengthen the protection of a sponsor's intellectual property rights, the maximum 6 years' data protection/exclusivity period is set for innovative chemical drugs, and the same varieties are not allowed to be listed during the protection period. The patent protection period for the maximum of 5 years will be compensated for drugs that are launched synchronously in China and globally.
"This is an exciting time to run a clinical trial in China," Philip Gregory, Managing Director of George Clinical, China said following the announcement. "There is a remarkable push by the Government to make sure that China is at the forefront of R&D globally. With this dynamism, there is an opportunity! George Clinical continues to support the Government's initiatives to bolster the R&D sector in China. As one of the earliest proponents of running pragmatic clinical trials in China, George Clinical will continue to support our Sponsor's to make the most of these opportunities, earlier and more effectively."
About George Clinical
George Clinical is a leading independent Asia-Pacific based clinical research organisation (CRO) with global capabilities differentiated by scientific leadership, innovation, and extensive investigator networks. With staff operating in 13 countries, and with significant operations in the USA, China, India, and the broader Asia Pacific region, George Clinical provides the full range of clinical trial services to the biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration, and post-marketing trials.
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Source: George Clinical
