BASEL (Reuters)—A regulatory backlog in developing countries including China has created wait times for drugs awaiting approval of up to seven years, Roche Holding AG Chief Executive Severin Schwan said on Tuesday.
“Unfortunately, time lines are getting longer and longer in countries like China,” Schwan said at an oncology event at the Swiss company’s headquarters in Basel. “The authorities are still in their infancy.”
Schwan estimated an approval backlog had added “five, six, seven years to the regulatory process, on top of what we see in the developed countries”.
China’s official Center for Drug Evaluation said this year more than 18,500 drugs were awaiting approval at the end of 2014.
That was up by a third from a year before, adding to industry concern that it is getting harder to get medicines approved in the Chinese market.
Schwan did not specify which Roche drugs were among those whose approvals are delayed.
In previous decades, emerging countries including China recognised their authorities were ill-equipped to adequately scrutinize new pharmaceuticals, he said.
Consequently, they deferred to regulatory decisions by authorities in Europe or the U.S.
That has changed, Schwan said, as developing countries assert their independence.
While it may be understandable that China wants an independent regulatory system to oversee medicines, Schwan said, patients were suffering because of delayed access to medicines during the transition.
“In certain developing countries we see huge issues,” he said. “In a sense, it’s