On track: More health foods expected to be approved via registration track in China as 2020 figure hits new high
This was around twice as many as in 2019, where 342 health foods were approved, statistics tabulated by China regulatory consultancy firm CIRS. has shown.
It should be noted that none of these products approved last year came from overseas enterprises.
Most of the products claim to strengthen the immune system.
In China, health foods can be approved via the registration or the filing route, of which, the former is opened to products containing raw materials not listed in the Health Food Raw Material Directory.
As such, it also takes a longer time for a product to be approved via the registration as opposed to the filing track.
Out of the 715 approved products, 610 made only one health claim, of which, 60.49% (369 products) have made the claim of strengthening the immune system.
Another 43 products have made two health claims, with strengthening the immune system and reducing fatigue as the most common claims, as seen in 41.86% products.
Seven claimed to supplement vitamins and minerals.
The health claims made by the remaining 55 products were not publicly declared, but according to the raw materials used, it is likely that most of these products would claim immune boosting properties.
Immune boosting was the most common claims mainly because it catered to the needs of the general population, Cathy Yu, senior food regulatory consultant and GM of the Food Business division at CIRS told NutraIngredients-Asia.
“There is also no need to conduct human clinical trial for products that claim to strengthen the immune system, which makes it easier for companies to make such products as well in terms of the dossier requirements,” Yu said.
Nonetheless, there are also other factors such as market demand, the areas that a particular health need that a company is focusing on, Yu added.
This year, it is expected that more products would be approved via the registration track as the approval protocol becomes more clearly defined, Yu said.
When both the health foods filing and registration tracks were introduced in 2016, the framework, which was still in its infancy, saw slow progression.
It was only two years later when 10 products were approved via the registration track.
This led to a bottleneck in the number of applications that the regulator needed to go through, which has been subsequently alleviated from 2019, Yu explained.
For the products approved last year, most of their applications were reviewed between 2013 and 2015.
Not taking into account the lack of momentum when both the registration and filing tracks were introduced, on average, it takes about four years for a product to be approved.
However, as the authorities clear the bottleneck, Yu said it could be expected that the review period from now on would be shorten to three years.
Why no overseas products?
No overseas products were approved via the registration track last year, which could be attributed to two reasons: 1) local applications submitted before July 2016 were considered first and 2) there was a much lesser number of applications coming from overseas firms.
“As the transition to the new registration and filing duo track framework has caused the review process to stall for a period of time, the authority has prioritised the reviewing of applications submitted by local firms before July 2016 [which was before the introduction of the new framework],” Yu said.
“Subsequently, the authority might review those which are applying for extension of the product registration validity, change in product registration, or technical transfer, before reviewing the applications of the imported products.”
As the registration track is more complicated, time and financially consuming, this has deterred overseas firms from applying for product registration, in turn, leading to lesser number of successful applications as compared to that of the local firms.
Beijing and Guangdong leading the pack
Out of the 715 products approved, most of them came from companies based in Beijing, followed by Guangzhou.
Yu explained this was because there were more health foods enterprises based in these two locations, hence there were more applications coming from them.
There were 131 products (18.32%) coming from companies based in Beijing and 121 (16.92%) coming from the Guangdong province.
Out of the 492 enterprises with products approved, most came from Beijing Shiji Hehui (北京世纪合辉医药科技), with 19 products approved. This is followed by Beijing Dingweifen (北京鼎维芬健康科技), with 11 products approved.
Capsules most common
Capsule is the most commonly seen dosage format amongst the approved products.
About a-third of the approved products (218) were capsules.
Tablet, soft-gel capsule, and powder were the next most commonly seen formats, with 131, 128, and 82 products made in these formats.