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It may be a good time to enter the China market now but it is not an easy task. Many have failed entry into the China market as they do not fully understand the seri

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

ousness of the complications of the Chinese business culture in the China market.

China is growing as such a fast rate that many foreign companies are attracted to

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

Examples of combination products may in

t. However, foreign investors need to understand China itself as a country economically and culturally.

China market is a good investment but also a big problem to

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

many foreign companies. Due to language and culture barriers, many foreign companies do not have the ability to communicate in the China market and many ideas and op

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

ortunities are interpreted the wrong way. Hence, foreign companies would need to fully understand the Chinese culture and language before entering the China market.

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

Combination pro

The China market also works in a way that networking is an important tool among the locals. The Chinese feel that relationship (“guan xi”) is the method to work arou

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

nd the China market. Having a good relationship with others will aid in paperwork and procedures and minimize any problems or issues. For example, if a new local com

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

any wants to register itself with the government, having “guan xi” with some government officials will allow the company to know how to go about registration and wha

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

to look out for.

Foreign companies would also need to do up a detailed China market research as the China market is considered to be relatively new compared to tha

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

t of the US and Europe. Thus, foreign companies would need to understand the strengths and weaknesses of the China market.

In addition, a up-to-date consumer resear

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

h would also need to be done. The local consumers play a big role in the China market and with more of them getting more affluent, their needs and wants are changing

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

Following aspects would a

over the years. Thus, an updated consumer research is important to the marketing strategy and product development of foreign investors.

However, conducting a market

dd to the challenges in developing combination products:

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

research may not be the same as carrying a research overseas. The Chinese tend to be overly-concerned about “face”. The Chinese have the mindset that they need to p

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

esent their ought self in front of others all the time. Thus, it may not be easy getting the true response and feelings of the Chinese consumers as they tend to give

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

the politically and safe response.

The Chinese have their own style of expression which may tend to frustrate a lot of foreign companies. Many foreign investors are

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

unable to communicate effectively with the locals as they do not understand the different responses and expressions of the Chinese.

Thus, foreign companies really

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

Professional from academic institutions, pharmaceutical industries, health care indust

eed to understand the China culture before entering the China market as the China market may create a lot of frustrations to the foreign companies. The best way to u

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

derstand the China culture is to engage a local party to guide you as they are more familiar with the local touch. Furthermore, the possess the language skills and t

.

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

actics to interact not only with the locals but they also understand the needs and wants of that of the foreign companies. Furthermore, they would be in a better pos

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

Companies that provide selfless information through particip

tion to negotiate in business meetings as not only would clients prefer to talk to someone familiar, they know how to read expressions of that of the Chinese clients

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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