Advice You - Business

In the last two decades, no country like China has received so much coverage worldwide. Their economy expansion has attracted many foreign investors who want to get a piece of the growing economy. Furthermore, with re

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

gard to the WTO, China has been relaxing their restrictions on foreign investments regulations. This actually indicates that the government is supporting foreign investors to enter into the China market. China is plac

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

Examples of combination products may in

ng more importance to the quality rather than the quantity of foreign investment. This shows the development of the China market where they are focusing on refining their economy as they expand further.

The growth of

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

the China market is increasing as such a high speed that the number of foreign companies is flocking in each year. From 2001 till 2005, China has attracted 345.6 billion U.S. dollars in foreign investment more than

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

the 323.3 billion dollars that poured in over the nine years from 1992 to 2000. China market’s appeal to foreign investors are growing at such a rapid rate that China’s economy is no longer just a production factory.

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

Combination pro

Foreign companies are entering into China not only to produce their goods but also to selling their products to the local consumers. However, entering the China market needs a lot of tactics, networking, and famili

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

rities.

1. Tactics

Many of the foreign investors who enter into the China market have a huge amount of experience in business administration and marketing strategies. However, the Chinese have a different way of doi

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

ng business and most foreign companies do not have the correct tactics to deal with things in China.

2. Networking

Most people would agree that networking is very important for business dealings. With a strong netwo

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

k, we will be able to seek for help or consult someone if any problems were to occur. In China, networking or “guan xi” is one of the main methods which the Chinese use. “Guan xi” is the Chinese term that the locals u

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

se. The Chinese believe that everyone needs to establish good relationships with others. The only way to really survive in China is through “guan xi”.

Foreign investors may think that as long they have good business

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

elationships with other organizations would lead them to be successful in China. However, this is only partially true. In China, any kind of relationships are important. Be it a personal or business or even government

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

Following aspects would a

al relationship, all of them are crucial in establishing a successful enterprise.

With good personal “guan xi”, the Chinese can rope in people whom they can trust into their business. The Chinese believe in having tr

dd to the challenges in developing combination products:

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

st among their counterparts.

With good business “guan xi”, the Chinese would be able to negotiate easily and collaborate with others to ensure a lasting partnership with other parties. Having business “guan xi” would

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

allow the local companies to meet more clients and suppliers to expand their business.

With good governmental “guan xi”, the Chinese would be able to settle their bureaucratic and administrative work faster as their

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

contacts would be able to advise them on a personal level. Furthermore, any problems encountered with the paperwork, the Chinese would be able to seek help through their governmental relationships.

Thus, the Chinese

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

value relationships very highly and even though their business with their contacts failed, the Chinese would continue to maintain a close relationship with them.

3. Familiarities

To enter into the Chinese market, on

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

Professional from academic institutions, pharmaceutical industries, health care indust

must have a good grasp of the Chinese culture. As different countries have their own unique way of values and working styles, lots of conflicts tend to arise due to differences. Thus, the foreign companies need to fa

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

miliarize themselves with the Chinese culture and understand how the Chinese work.

For example, without a full understanding of how the Chinese handle with the authorities can bring a lot of problems to the enterpris

.

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

. The way the Chinese communicate to the authorities differs from how the way it works in other countries such as the US and Europe.

Hence, one of the best ways to familiarize themselves with the Chinese culture is t

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

Companies that provide selfless information through particip

o engage a local individual or firm as the link between the foreign company and the China market. Local parties have the expertise to handle any problems and have a better idea on how to negotiate with the local firms

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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