Main Subject - Business

Mainly there are 3 ways whereby one can export his/her goods in China:

1. Distribute your goods directly
2. Establish a joint venture
3.

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

Find a qualified agent or distributor with a vast sales network

Before exporting your goods into China or choosing a Chinese partner, it is advis

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

Examples of combination products may in

ed for you to conduct thorough market research and due diligence. Companies should be mindful of possible problems in export rights, regulations an

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

d intellectual property rights protection. If the company decides to distribute the goods directly, then it will have to be aware of the distributi

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

n rights and understand the licensing process in China.

Distributing your goods directly may be a complicated and time-consuming process as one ma

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

Combination pro

y not be familiar with China’s business practices and government regulations. Application for distribution rights and establishment of own distribu

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

tion channels will be difficult. Chances of failure will be higher as a result. Establishing a joint venture will thus be a better option. Establis

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

hing cooperation with a local partner can allow you to have faster access into China’s market and with the local partner’s knowledge and experience

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

of China’s market, your success rate will be higher and goods can be better distributed.

Acquiring help from a local partner does give you many a

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

dvantages in penetrating the China’s market. A side issue to note will be that joint venture usually requires large amount of capital and China’s g

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

overnment may have capital control towards outflow of funds should one transfer his/her funds back to his/her home country. The government will als

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

Following aspects would a

o need to assess the potential economic benefits that it can bring to China, e.g. does it create job opportunities for the local population before

dd to the challenges in developing combination products:

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

pproving it.

For small and medium sized companies, the best way to enter the China market is through a reputable or well-known agent or distributo

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

r. These companies are located regionally and typically have large sales network. Thus they will be able to have a better understanding of the Chi

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

na’s market and can provide assistance in developing distribution strategies in China and the region. In this way, new products can be launched eas

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

ier into the market and distribution network can be set up rapidly without any problems dealing with distribution rights and licensing.

Besides al

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

Professional from academic institutions, pharmaceutical industries, health care indust

these, the most important step that one must take before exporting his/her products into China will be to have a thorough understanding China’s cu

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

stoms, regulations and controls towards imported goods. A sound market entry strategy is also necessary in order to penetrate the China’s market su

.

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

ccessfully. An assessment of your goods’ strengths, weakness, opportunities and threats can allow you to promote and distribute your products bette

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

Companies that provide selfless information through particip

r. Understanding the profitability and marketability of your products in the China’s market is thus vital before exporting your products into China

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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