Forbes magazine recently polled 50 drug multinational company executives asking them what was most important in their dealings with China, and 86% of those interviewed said reforms to the China Food and Drug Administration (CFDA) "were going to be essential for their company's future" there.
The executives said reforms at the CFDA would allow new drugs into the China market faster, would improve the infrastructure for "domestic innovation" and would raise standards by "thinning out" manufacturers whose capabilities do not meet global standards, Forbes reported.
"To get a sense of how bad this is, one has to keep in mind that the CFDA receives over 10,000 new applications a year, while as of today it has the bureaucratic capacity to review between 5-6,000 a year," Forbes said in its report. "Today, the backlog of new drugs in need of review stands at more than 21,000. Making the approval process harder, and shifting more of the burden to companies who submit drugs for review in the first place, will begin to clear the air."
China has made some progress on its reform efforts and said this week it was cracking down on "suspect" drugs and had rejected applications for 11 medicines, according to a report by Reuters.
The CFDA said on Nov. 11 its decision affected 8 Chinese companies making generic drugs for heart problems, schizophrenia, pain, infections and other diseases, Reuters reported.
"The CFDA seems very, very determined on this quality issue and that could change the Chinese pharmaceutical industry in a big way," a senior executive with a multinational drugmaker told Reuters.
Executives interviewed by Forbes said reforms at the CFDA would also bring in additional benefits like putting China on the radar for companies that currently do not view the mainland as a venue for global product launches because most multinationals wait until their drugs are well into commercialization elsewhere.
Forbes said as global companies focus more on China launches they will search for new models for sales and marketing, and the modern take on "new technology and platforms around how to talk to Chinese key opinion leaders … will grow more focused, with benefits to companies such as Dingxiangyuan, Xingshulin, Menet, and SeaRainbow who provide either digital interfaces or insights driven made possible by big data."