Main Subject - Business

China’s economic power has been on an increasing rise ever since China opened up it economy few decades ago. This move has allowed China to develop and progress tremendously. The grow

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

th of the China market is overwhelming to both the Chinese and the world around. Statistics showed that China has been enjoying a two-digit growth from 2003, and its economic growth r

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

Examples of combination products may in

te in 2006 even reached 10.7%.

However, China market does have its risky side. Chinese consumers have a strong national pride so multinational companies could lose important market s

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

gments by seeming too foreign to the locals.

Government regulations on foreign investments involve a lot of complexities for foreign companies when they try to enter into the China m

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

rket. As most of the foreign investors are unfamiliar with the bureaucratic procedures, many faced a lot of difficulties and delays in their business opportunities. Hence, it is cruci

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

Combination pro

l for foreign companies to familiarize themselves with China business style before starting on their plan to enter into the China market.

The Chinese have a collectivist mindset wher

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

eby most of them like to fit into the society and they like to establish good relationships with others. The Chinese are usually concerned of the views of others. In China, the word “

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

uanxi” means having a close relationship with others. It does not matter whether the relationship is on a social or business level but as long they have a network with others, the Chi

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

ese believe that they will be able to get things done faster.

In China, the people treat “Guanxi” with high regard. The parties involved will try to keep the relationships as much as

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

they can and enjoy mutual benefits. Usually, the Chinese will seek for a win-win situation by giving-and-taking most of the time. This type of business style usually differs from that

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

of the foreign companies. However, foreign investors need to understand the amount of importance that the Chinese places on “Guanxi”. In China, the people need to have a good trust fo

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

Following aspects would a

undation to have business dealings with others.

Foreign investors can familiarize themselves through market research or to seek an appropriate local partner before plunging into the

dd to the challenges in developing combination products:

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

hina market. Having a local partner would enable the foreign companies to link with the local market and thus increase efficiency and minimize any risks involved. A local company woul

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

know how to negotiate with local suppliers and wholesalers and they also have a better idea on how to handle complicated administrative procedures with the government.

Many foreign

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

nvestors actually consulted local individuals or parties such as business or consulting firms who are able to provide professional advice and assistance regarding the China market. Wi

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

h professional help, foreign investors would find China market entry to be less complicated and frustrating. Furthermore, local professionals would have the necessary network to allow

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

Professional from academic institutions, pharmaceutical industries, health care indust

foreign investors to establish their business in China.

In addition, even though the China market is full of business opportunities, the market is saturated with competition. With t

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

e increase of local companies partnering up with foreign companies, the domestic industry is increasing in the product quality and gaining more market share. Thus, foreign investors h

.

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

ve to keep in mind to fight against the strong local competition as many of them had to lower their prices seriously to gain more market share.

One of the ways to fight against stron

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

Companies that provide selfless information through particip

local competition is to have a detailed consumer research to find out the demands and needs of the present consumers and what products are substitutes and complement products to them

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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