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

In 2008 the Beijing Olympics took China well into the modern world and now, in 2009, China celebrates the 60th anniversary of the founding of the People's Republic of China. The UK is hosting a high profile red carpet and VIP reception to celebrate this 60th anniversary. Guests to include politicians, senior figures from the Chinese and UK business communities, celebrities from music, television and film. Representatives from Global Regulatory Services have been given the opportunity to attend this event and witness the raising of 60 Tang Dynasty style lanterns each signifying one of the past 60 years. It is certain to be another memorable event which will marry the traditional with the modern.

I mention this because the Beijing Olympics were crucial for demonstrating to the world that China can provide quality products and services. No doubt the 60th anniversary celebrations will reiterate this. China, however, is still having to deal with corruption and fraud on a grand scale which is particularly prevalent in pharmaceuticals. This is one of the reasons why companies are hesitant about setting up in China. The 'soft' approach is to establish a strategic alliance or partner with an existing credible Chinese company who has local knowledge and experience. This is exactly what Global Regulatory Services (GRS) did.

Heavy investment by the Chinese government is encouraging the development of new pharmaceuticals and medical devices. Couple this with local young and enthusiastic scientists who have been educated in Europe and/or America, it'll come as no surprise if China should gain the lead in developing truly innovative medicinal products. This reflects modern China but what about historical, traditional China?

Part of historical China is based on Traditional Chinese Medicines (TCMs). These should not be mistaken as simply herbal remedies as they also include products such as acupuncture which is now readily accepted by the UK's National Health Service (NHS).

There are currently two key challenges facing herbal TCMs:

(1) To market these in Europe, they will now require a Traditional Herbal Medicines Registration (THMR) or a full Marketing Authorisation (MA). The advice from the Medicines and Healthcare products Regulatory Agency (MHRA) is to register 'simple' products first (consisting of 1, 2 or 3 herbal ingredients) so that companies can learn the process and also give the Regulatory Authority time for assessment and approval during this steep learning curve. Many herbal TCMs, however, are very complex consisting of numerous herbal ingredients.

(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. The Chinese don't simply treat a symptom with a remedy, they also must consider the person as a whole i.e. holistically.

In an attempt to address these two challenges (as well as others), a three year project (GP-TCM) was given the 'go ahead' earlier this year for a research consortium 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.

"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).

The directors of Global Regulatory Services (GRS) are great believers 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. Their involvement will be in the form of presentations at 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.

Author: Greer Deal, Director of Global Regulatory Services