Xiao Yao Wan Becomes A Legally Registered TCM Formula in the European Union - But TCM Regulations Vary

EU member states arguably have better healthcare systems, cost controls and outcomes over countries such as the United States (general source).  Along those lines, the EU has made tremendous strides in broad ranges of consumer and data protections and workers rights, among other advances.  Within the realm of Chinese Medicine, however, they have not performed as well in proper regulation, usage and general acceptance.

Chinese Medicine usage and regulations vary wildly across the EU.  In some member states an MD is required to practice acupuncture, in some it isn’t, and some it isn’t regulated at all.  Chinese herbal medicine availability, legality, etc. also vary.  Generally, Chinese herbal medicine has faced a tough road through the regulatory processes of the EU - (source and another).

While on average I appreciate the role the EU policies have played in both avoiding excessive commercialism/advertising of medicines and in controlling costs, they have not been pliable enough for Chinese Medicine (which has a wildly extensive historical and current usage history - certainly compared to nearly any western medicine available).

Recently researchers from a range of Chinese institutions, including members from Tasly Pharmaceuticals, presented a paper discussing the relatively arduous process they went through to make the infamous Chinese herbal formula Xiao Yao Wan among one of the first to be successfully registered via the EU processes.  What is known in English as the “Free and Easy Wanderer”, was successfully registered to “relieve the symptoms of mental stress and exhaustion”.

As an aside, Tasly pharmaceuticals has offices in the US, Europe and is based in Tianjin China, they primarily handle Traditional Chinese Medicine herbal formulas - while not directly part of the paper, their size alludes to the amount of legal and financial overhead one must be able to meet to go through this process.

The general rules for EU acceptance of herbal products are discussed in some details within this document.  Long story short it is a complicated process.

The herbal regulation process was “simplified” in 2004, but remains somewhat vague in how it can be interpreted.  From their Q/A on the process, for example, they state “…This means that the herbal medicinal product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the EU” and “The data on the traditional use of the herbal medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience.”  While both of those sound both valid enough for Chinese Medicine and vague enough to gain approval for many formulas, it is apparently not that straightforward.

According to the researchers while this simplified procedure “has played an import role” in allowing more herbal products into the EU framework, there still are only a few from Chinese Medicine that have been registered.  These include:

Diao Xin Sue Kang (2012)

Danshen Capsule (2016)

Phynova Cold and Flu Relief Powder for Oral Solution (2017)

YuFeng Ningxia Tablet (2019)

And - Xiao Yao Tablets (2021)

The two major challenges are showing efficacy and safety in a way that meets the needs of regulators.    For efficacy, in the case of most formulas, showing 30 years of usage/safety history within China is fairly easy.  Finding 15 years of usage history within the EU, however, is an entirely different story.  The researchers also mention that “effective evidence should be able to prove that the proposed indication is consistent with the traditional use, and the indication should also meet the requirements of self-treatment at the same time”.  This is complex, as most Chinese Medicine formulas are by the nature of the underlying diagnostic system, rarely for “one” thing.  While it may not always be appropriate or the “best” formula, Xiao Yao Wan is one of those examples, however, where you can feel a little more easy about allowing people with “stress” to utilize it.  Other formulas would be far more complicated to get in line with these constraints.

As practitioners will understand, these processes are not in line at all with the value of the Chinese Medicine diagnostic procedures.  A primary value of the medicine is in tailoring to the individual.  However, even the most ardent supporters of the field as a whole, when viewing global health issues from a cost and results standpoint, would likely come around to the idea of global availability for certain formulas - even with the knowledge that under the guidance of a practitioner there are likely better options.

A related problem in this regulatory process was that “the formula and indication” of whatever formula they are trying to get through the regulatory process “has to be fixed” and the clinical indications of that formula have to be translated “from traditional words into modern medical terms”.  Most manufactured formulas are relatively fixed - but not ultimately.  Both preferences and supply issues may factor into what is the full composite of a particular formula from a given supplier.  Besides complications in passing regulatory processes, this also heavily restricts production capacity as ingredients would not be able to be swapped if/when necessary.

Then there is the “translation” issue - the translation of concepts such as “liver qi stagnation” into “depression” is troublesome at best and functionally “knee-caps” the diagnostic system in order to help gain availability and global usage.

So what should happen?  Well for myself, I don’t know.  I would prefer to see proper broad acceptance of licensing/regulation for practitioners of Chinese Medicine across EU member states.  With that the freedom for the practitioners themselves to have unrestricted access to the full Chinese pharmacopeia, pre-manufactured and raw.  But if herbal medicine need to go through these processes, it should at least come with required training for the medical practitioners in their proper utilization.

All in all this study describes processes that have made the integration of Chinese Medicine into the EU more troublesome than it need be.  And accepting the relative risks of fundamentally enforcing self-treatment with herbs rather than a full regulatory framework for the proper practice of Chinese Medicine is troublesome.  While there is room for improvement, the way integration has happened in the US is by far superior to what has happened in the EU.  When you consider the health benefits, cost savings and minimal overall risks involved with Chinese Medicine, it seems that EU citizens would benefit from tackling this at a broader regulatory level and creating a system akin to what the US and Canada have.  Only time will tell how this will all play out.  But for now, this is a good exploration of the work involved in the proper acceptance and integration of Chinese Medicine.