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.
You may also be interested in...
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.
Increasingly looking to China to commercialize their latest therapies, multinationals may be leaping into unknown waters to navigate an intellectual property judiciary and administrative maze, in a country where some copy drugs have been approved before patent expiry. With a government trying to balance innovation and access, two recent rulings involving AstraZeneca shed rare light onto China’s protections for innovation, with advisors pointing to challenges and success factors.