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Although Chinese medicine is conceived as alternative medicine outside of the Far East it is still considered the primary medical system in China,

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

and has been for thousands of years. Because Chinese medicine relies on natural healing rather than synthetically produced drugs, more and more peo

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

le in the Western world are turning to this branch of medicine.

Whilst Chinese medicine is thought to date back for 5,000 years the origins are fa

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

r from clear. The first recorded history is thought to date back over 2,000 years with the first written document concerning Chinese medicine thoug

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

t to be Hung-Di Nei-Jing(Cannon of Internal Medicine) and is attributed to the Yellow Emperor, although there is confusion over the dates and autho

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

s and is still the subject of much debate.

Most people are familiar with the primary methods of healing within Chinese medicine, which are herbal

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

medicine and acupuncture with other methods such as massage, qi gong, or food therapy playing a secondary role. But few know that restoring harmony

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

and regaining balance rather than treating the disease is the aim of all traditional treatment.

A lack of harmony is seen as the main cause of any

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

illness. Whereas modern medicine treats bacteria and viruses directly by the use of antibiotics or vaccines, Chinese medicine has a holistic view

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

nd targets the imbalance with the philosophy that well-balanced human bodies can resist most everyday illness and disease.

While more and more med

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

cal schools are including classes on alternative medicine in their syllabuses, the relationship between TCM and Western medicine is still contentio

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

us. Older Western doctors are far more likely than their Chinese counterparts to view Chinese medicine with superstition.

This is not to say that

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

he techniques are of no value in the West. In fact, drug companies have acknowledged the value of traditional medicines and teams of scientists in

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

many parts of the world are employed to accumulate knowledge from traditional medical practitioners. In addition, many Western hospitals and incre

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

sing numbers of clinics now offer T'ai Chi Ch'uan or qigong classes as part of their inpatient and health programs.

Chinese Medicine is not cons

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

dered alternative medicine to over three quarters of the world’s population and it is precisely in the areas of prevention and dealing with physica

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

l or emotional illnesses that it excels. It has been developed over the years as a form of non-invasive, therapeutic and risk free treatment.

Atti

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

udes towards Chinese medicine are changing by the day and an increasing number of people are finding relief in this form of alternative medicine a

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

fter failing with modern medicine and prescription drugs. But rather than as a last resort as was often the case it is now becoming a first recours

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

and more and more people are having regular treatments to maintain their health at an optimum level or to help with addictions or dietary problems

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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