Source: United States & Canada – South China Morning PostIn the summer of 2015, a time when China’s pharmaceutical market was in a phase of rapid expansion, a sudden regulatory change sent tremors through the industry: drug companies would need to audit the clinical trial data for all pending applications.
If withdrawn within a month of the announcement, firms could avoid penalties for submitting flawed applications, but hiding or falsifying data would court severe punishments, including multi-year filing bans.
The response from the industry indicated…Read More