According to the CFDA’s proposal, if a trial sponsor is found using fabricated data for drug registration, the agency won’t accept its NDA application for drugs in that same category for three years, as well as all NDAs for a year.
This seems like an inordinately light punishment for the crime in question.
While foreign companies have historically had to wait several years to bring treatments already approved in other countries into China, the country is speeding up its review of new medicines to combat increasing rates of diseases like cancer and hepatitis.
NVS’ Votrient and Jakavi recently received approval in China.
China revenue in the third quarter increased by 12 percent at AstraZeneca and the country now accounts for 15 percent of its global product sales - a far higher proportion than at other big pharma companies.
… straZeneca has had five new products recently added to the country’s National Reimbursement Drug List - Onglyza for diabetes, cancer drugs Iressa and Faslodex, heart medicine Brilinta and antipsychotic treatment Seroquel.