SHANGHAI – At the recent China Healthcare Investment Conference (CHIC) – where investors and Chinese biotech CEOs meet up to try and make their investment dreams come true – the theme was growth vs. innovation. Whether innovation stems from growth or growth comes from other drivers, both appear to be significantly helped along by the recent spate of CFDA regulatory reforms.
When China's State Council issued circular No. 44 in 2015, the CFDA became empowered to fix many of the problems that had been plaguing the industry. Since then, regulators have unleashed a steady stream of guiding documents and regulations that have left the biopharma industry scrambling to keep up, but on the whole very pleased; the CFDA reforms have started to clear the backlog of drug applications and inch China closer to the U.S. or EU regulatory environment to support new drug applications. (See BioWorld Today, Oct. 22, 2015.)
But even in an environment of almost weekly updates and staggering changes, Ruijin Song, the executive president of Sino-PhIRDA, the China Pharmaceutical Industry Research and Development Association, a powerful industry trade group that communicates closely with policymakers, said at CHIC that "the recently launched draft CFDA documents were a big surprise; it will allow foreign clinical data to be used [in a new drug application] – no longer requiring imported drugs to be approved in the site of the manufacturing country."
The latest proposed reforms, still pending confirmation, open up the possibility that clinical trial data from overseas – as early as phase I – will be accepted by the CFDA in applications for new drugs. That puts out the welcome mat for multinational corporations MNCs as well as Chinese biopharma prescient enough to kickstart trials abroad. The requirement to test on Chinese patients in China looks set to be less relevant. (See BioWorld Today, March 22, 2017.)
"This is a big mindset shift for the regulators; it's not about how to maintain sovereignty but making it the purpose of regulators to improve quality of life for people by providing access to safe and efficacious products. It is not about letting some make money and not others," Song said.
The biggest winner looks to be the Chinese patient, who could have access to the most innovative and effective drugs three to four years earlier than before. It should also bring a wave of new entrants into the China market, which according to Elon Musk, entrepreneur extraordinaire, is the main driver of innovation. What Tesla has done for the car market, so too could a wave of new drugs coming to China for the first time, challenging the industry to move beyond less risky me-too and me-better drugs.
After years of pouring billions of dollars into China's biopharma industry and providing policy support, actual results have been slow in coming. From the vantage point of today, for all the talk of innovation in China, there is little that is first-in-class and little that can be talked about globally.
Growth, however, is a different matter. Until recently, China has had little problem with growth, and the health care sector remains one of the bright spots in the economy. Over the last decade, China's health care industry grew nine times faster than China's national GDP, according to Song. He also calculated that in the last 10 years the U.S. NIH had spent $8 billion compared to China's $2 billion for pharmaceutical research.
But for first-in-class drugs, "China has zero," said Song, while the U.S. delivered about 10 a year on average over the past decade.
Given more policies are soon to be launched that will move China even closer to following international practices, Song closed his remarks on a positive note: "With such a huge population, we should be confident and not just focus on the weaknesses but focus on the advantages; there are a lot of big changes waiting for us."
A VERY BUSY CFDA
The CFDA speaker that followed showed just how hard at work the agency has been to meet its fourfold objectives: to improve quality, improve efficiency, encourage innovation and be more open and transparent.
To improve the quality of drugs, the director of the medicine registration center of the CFDA, Yu Huan, said that since the State Council issued circular No. 44, the agency has issued 120 guidelines covering everything from chemical drugs to biologics, along with the definition of new drugs to follow the international standards.
"These have guided the research and development for the industry. We want to guide the quality in the market; it is about catching up." He went on to say that as of January, his office was processing applications for 330 new drugs under class 1 and class 2, "showing that the polices have had an active role" in that regard.
He pointed out that technical guidelines can be searched online on the CFDA website, including review and evaluation documents. Information transparency has been further improved with electronic submissions and a move toward using the common technical document (CTD) system of the ICH. There is also greater information disclosure once drugs have been approved.
"Since last year, on the CFDA website we publish a list of approved drugs, the name of the drug, indications and the review report, to guide the industry and to avoid overlapping applications," said Huan.
Regulators have also been on a talent search, hiring more reviewers and overhauling the system of communication between reviewers, principal investigators and sponsors. Currently, Huan said the agency has 400 reviewers and is aiming to have 600 by the end of the year. Drug applications are now the responsibility of a team leader who will coordinate the review and liaise with an expert advisory board.
Huan gave some hope that more good news may be coming down the pike. "In future, there might be a move towards a 60-day clinical trial approval," he said. While that is twice as long as the 30-day system in the U.S., where applicants are free to move ahead with a clinical trial unless they have been contacted by the FDA, it is much better than China's past system, where sponsors could be left in a limbo lasting 18 months to two years.
And he gave a glimpse behind the curtain to the debates ongoing about the use of clinical trial data from outside of China.
"We are discussing how to accept foreign clinical trial data. If they have finished early stage trials and come to China for later-stage trials and want to market in China, can we follow ICH guidelines? This is being considered," he said.