Fake Clinical Data No More: China To Criminalize Forgery
China is planning to enact changes that will view the intentional forging of clinical trial and other data submitted to gain drug approvals as a criminal offence, punishable by prison terms of up to three years.
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China FDA now has more solid ground to enforce GCP norms. A legal explanation from the nation's highest People's Supreme Court clarifies responsibilities of study sponsors and CROs involving in data falsification.
Allowing early stage Phase I studies, setting a 60-day period for IND approvals, and dropping a requirement for hospital to get certified, the China FDA proposes fundamental changes that would allow any qualified sites to file for approval to get studies rolling.
While many pharma firms in China choose to partner with US companies, Jiangsu Hengrui is relying on itself to go global. The Chinese pharma giant is betting on its newly established US subsidiary Luzsana in a major move to make its wide-ranging products more available, accessible and affordable to patients in the US and the rest of the world.