China: can traditional and modern medicinal products live in harmony?

In 2008, China hosted a memorable Olympics in Beijing and now, in 2009, they are celebrating the 60th anniversary of the founding of the People's Republic of China. The UK is supporting this 60th anniversary by hosting a high profile reception to be attended by key members of the business community and celebrities used to the red carpet treatment. Global Regulatory Services have been invited to witness these celebrations which will combine the traditional with the modern.

 

The Beijing Olympics demonstrated that China can provide quality products and services. Unfortunately, she is still battling against large scale corruption and fraud which is why many companies are hesitant about setting up in China. To overcome this hesitancy, many venture into China be establishing a strategic alliance with an existing credible Chinese company who has the local knowledge and experience they are looking for. In fact, it is through such an alliance that Global Regulatory Services (GRS) is able to offer regulatory compliance solutions in China (see GRS Press Release; Regulatory Services for the Chinese Market.)

 

The Chinese government is investing substantially in the development of new healthcare products. It is likely that this financial commitment, combined with the European or American education of their young scientists, will help China to achieve her objective to be a world leader in the development of innovative healthcare products. This reflects modern China but what about historical, traditional China?

 

Traditional Chinese Medicines (TCMs) are steeped in history. They are not simply herbal remedies as they also include products such as acupuncture (now readily accepted by the UK's National Health Service).

 

When considering herbal TCMs, Chinese companies are currently facing two key challenges:

 

(1) To market these in Europe, they are required to apply for a Traditional Herbal Medicines Registration (THMR) or a full Marketing Authorisation (MA). The Medicines and Healthcare products Regulatory Agency's (MHRA) advice is to register 'simple' products first (of no more than 3 herbal ingredients) so that companies can more readily cope with the steep learning curve. The reality, however, is that many herbal TCMs include numerous herbal ingredients and therefore, are too complex.

 

(2) It is argued that, by the very act of registering a herbal TCM, the remedy will no longer be 'traditional'. There is a lot of history and Chinese culture intertwined with TCMs which cannot be ignored but which will not be an integral part of any submission dossier. Chinese practitioners don't just treat a symptom, instead they consider the patient as a whole i.e. holistically.

 

Earlier this year, a research consortium was established to run a three year funded project (entitled "GP-TCM") with their objectives being to review the current status of TCM research, identify problems and propose solutions by applying modern methods of investigation as well as providing a forum for the exchange of opinions, experience and expertise among scientists in the EU and China. This project should help to address the two challenges cited above.

 

"In contrast to the reductionist approach of Western medicine that is based on modern anatomy and cell and molecular biology, TCM uses a unique theory system and an individualised holistic approach to describe health and disease, which is based on the philosophy of Yin-Yang balance. These two medicine systems disagree with each other in many situations since they observe health from their own limited perspective. GP-TCM aims to inform best practice and harmonise research of the safety and efficacy of TCM, especially Chinese herbal medicines and acupuncture, in the EU" (Quote by Dr Qihe Xu, Lecturer in the Department of Renal Medicine, Division of Gene and Cell Based Therapy).

 

As a regulatory compliance consultancy, we strongly believe in culture and tradition and therefore are pleased to be involved in addressing the challenges facing those who produce herbal TCMs for the European market. Our involvement will be in the form of presentations, workshops and forums as well as future participation with the GP-TCM consortium.

 

So to answer the question "China: can traditional and modern medicinal products live in harmony?" Currently we can only respond "we don't know". From now on, however, with the combined efforts of people spanning the continents, all of us will be doing our utmost to establish a state of harmony between "tradition" and "modern" in the provision of global healthcare.