Raising the bar on talent
The report provided some interesting data points to buttress this reform agenda. It notes that in China it takes on average
a year and a half to obtain approval to launch a clinical trial—the less formal FDA notification process in the United States
typically takes no more than 30 days. In addition, staffing for regulation throughout China is kept abnormally low by quotas
that link hiring to a tiny fraction of the population being regulated. And the professional credentials of regulatory staff
lags significantly against the standard in industrialized countries. Only five percent of CFDA staffers hold a master's degree
or above; 45 percent of CFDA staffers lack even a bachelor's degree.
Susan Winckler, President of the Food and Drug Law Institute in Washington, who served in a personal capacity as co-rapporteur
for the work group on institutional structure and functions, told Pharm Exec that what is needed to accompany a new Drug Administration Law is adoption by the regulatory bodies of "an internal culture
of continuous improvement." She notes that the challenges facing the Chinese system are actually the same everywhere—it's
simply a matter of degree. "The US FDA is also resource-constrained and is under similar pressure to be more predictable and
transparent in the way it operates." Winckler believes that the Tsinghua project should thus act as stimulus to a broader
dialogue to which regulators in all countries can contribute. "Change will come about if that discussion includes not just
the regulatory community, but those who are regulated too."
Project phase II
Looking forward, CFDA officials anticipate that a first draft of a new Drug Administration Law is likely by the end of this
year, and it has invited Tsinghua to contribute ideas to help shape the process. In September, the Pharmaceutical Law Institute
team will commence a second phase of the project, with three new work streams to address the following topics: pharmacovigilance
and risk management standards; a regulatory pathway for biologics, including biosimilars; and legal/product liability reforms.
Since the thrust here is to identify and transfer best practices that might prove useful to China, Tsinghua hopes to draw
in contributing experts from Europe and other mature countries, in addition to the United States.
William Looney is Pharm Exec's Editor-in-Chief. He can be reached at firstname.lastname@example.org