Pharmacists at a Traditional Chinese Medicine clinic in Taizhou city, Zhejiang province, dispense doses of herbal medicine to consumers, on April 2. [Photo / China Daily]

Unapproved Chinese medicines will be removed from store shelves

BEIJING - Traditional Chinese Medicine (TCM) herbal treatments will be outlawed in European Union (EU) countries starting in May in a move that is likely to cost the industry $500 million a year and put about 100,000 practitioners out of work.

Under the EU legislation, named the Traditional Herbal Medicinal Products Directive, all traditional herbal medicines that have not received official approval will be pulled off store shelves.

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And, so far, none of the TCM products sold within the EU have been approved.

"The coming ban will deal a huge blow to the TCM industry in the EU," said Shen Zhixiang, secretary-general of the World Federation of Acupuncture-Moxibustion Societies.

The European market consumes about one fourth of the total TCM exports from China, according to statistics from China's State Administration of Traditional Chinese Medicine.

In response, Chinese commerce and TCM administrations are talking to EU officials in a bid to defer the ban to 2019, he noted.

Under the directive, which came into force in 2004, a seven-year mercy period was given to manufacturers of herbal medicines so manufacturers could register their brands.

"But the requirements were too tough for Chinese manufacturers," said Huang Jianyin, deputy secretary-general of the World Federation of Chinese Medicine Societies.

Experts estimate that the cost of getting a single TCM product into the EU market, including the cost of registering it and meeting all other legal requirements, ranges between $80,000 and $120,000. The requirements, such as a real-time stability test, also need extra investment and effort.

Many TCM producers hesitated while they waited for others to register their products first, said Shen, who explained that once a specific TCM medicine is registered, all manufacturers of that product would have been able to take a free ride.

However, with the mercy period set to end and the knowledge dawning on producers that it would have been easier to register products during the mercy period than it will be in future "it will now be even harder for TCM products to enter the EU market," he said.

A staff worker with the Beijing-based Tongrentang, a time-honored TCM brand and the biggest TCM producer in China, told People's Daily that the requirement to provide academic proof, such as the results of a large-scale clinical study, to show that a TCM product had been in use in the EU for at least 15 years, was another major barrier to getting products registered.

Other factors, like whether the production of the medicine harms wildlife and the fact that TCM medicines sometimes contain excessive levels of heavy metals and pesticides, as well as reports about adverse reactions, have also affected the chances of TCM products being officially recognized in the EU, Huang noted.

"A lack of understanding of TCM as a medical science among foreigners is the root cause of such problems," he said.

Fu Yanling, a professor with the Beijing University of Chinese Medicine, told Guangzhou Daily that TCM companies must improve product quality if they hope to be accepted in such markets.