HONG KONG – The CFDA has, over the last few years, multiplied supervision of imported pharmaceuticals while speeding up local drug reviews.
According to an annual report published on the CFDA website, the regulatory body conducted 49 inspections of overseas drug manufacturing facilities. That marks a dramatic rise from just eight inspections conducted in 2011.
"The standards for overseas pharmaceuticals entering the Chinese market have been pretty loose and undefined prior to this. But there has been internal pressure to tighten up the process and set a common standard. That's why the CFDA has been conducting more inspections, especially in the last two years," Serena Shao, CLSA's head of China health care research, told BioWorld Asia. The numbers of foreign inspections have been increasing yearly. In 2015, there were 34.
As part of the latest annual report, the CFDA said it found 117 deficiencies as part of its overseas inspections, of which three were critical and 18 major.
Some of the main issues that surfaced from the inspections included inconsistencies in production processes and sites compared to what was outlined during drug registration application; major changes to production processes without notifying Chinese authorities; and significant problems in data integrity with serious impact on drug quality.
At the same time, the proportion of the items under review was increased in last year's inspection rounds. Products under application for clinical trials, production and re-registration or going through supplementary application processes were included in the scope of inspections.
Throughout 2016, the CFDA carried out inspections in 19 countries. The biggest group was in Europe, where Chinese regulators carried out 33 inspections. The CFDA also carried out six inspections in North America, six in East and Southeast Asia and two in South America, along with one inspection each in Australia and India.
The regulatory body considered countries such India and Vietnam to be of "high regional quality risks." It also confirmed that "inspection on the varieties in South America and Australia was also intensified."
In February, the CFDA released a document, titled "Notice of CFDA on Matters Requiring Imported Pharmaceutical Products to Meet the Pharmacopoeia of the People's Republic of China," requiring all pharmaceutical products imported to China to meet specific variety requirements or general technical requirements as outlined in Chinese Pharmacopoeia.
The setting of a standard and a more vigilant overseas inspection process not only ensures quality products for Chinese consumers, but could also be beneficial for foreign companies entering China by streamlining the approval process.
"Though it might prove to be a barrier of entry for some companies, especially smaller foreign enterprises, it could actually speed up the product review process in the long run," Shao said.
With that, China also seems to be increasingly looking toward developing homegrown pharmaceutical innovations.
The CFDA has been speeding up drug registration and approval processes. The regulator reviewed 9,394 new drug applications in 2015, a 90 percent increase from 2014. The current review time could last anywhere from three to eight years.
China is the second largest pharmaceutical market in the world. The market is predicted to grow from $108 billion in 2015 to $167 billion by 2020, representing an annual growth rate of 9.1 percent. But there is much room for growth. Despite accounting for 20 percent of the world's population. China only has 1.5 percent of the global drug market.
Currently, pharmaceutical sales amount to 17 percent of total health expenditures, or $78 per person. In terms of the market breakdown, generics dominate with a hefty 64 percent of total sales.
An integral factor
According to BMI Research, human resources are an integral factor in speeding up the review process.
In 2015, the CFDA had a staff of 130 and just 80 drug evaluation specialists, according to BMI. By comparison, the U.S. FDA had a staff of 5,000 and Japan's drug regulator had 700, while the EMA had 4,500 experts. The lack of staff is a key reason behind the backlog of drug applications in China, according to BMI.
BMI also pointed to health care reforms that could boost orphan drug applications.
The CFDA has released a number of policies and documents to boost new drug applications from orphan drugmakers and improve access to treatments for rare diseases. Those policies align the practices in China along with those in use in Europe and the U.S. An expedited review program is expected in February 2018 that could grant conditional approvals to orphan drugs with prior approval in some Western markets without the need to wait for in-country trials.
At the same time, the CFDA is working to reduce the shortage of stuff.