Main Subject - Business

Foreign investors have always feared entering into the China market due to culture differences and language barriers. Many of them are worried that a change in their organization structure or a huge amount of capital wi

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

ll be needed when entering the China market. However, with the appropriate measures, a correct approach can be taken to ensure a smooth entry into China.

It took a long time and a huge effort of the government for Chin

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

Examples of combination products may in

a to become what it is today. The modern China is prospering and booming in its economy and the standard of living in China has been raised tremendously. In addition, the Chinese government has been supporting the growt

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

h of China’s economy whereby policies have been changed over the years to boost China’s revenue. China market is moving towards the direction where the market forces are the ones influencing the economic activities in C

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

hina.

Huge global giants such as Coca Cola, Nike and Walmart had successfully entered into China and became a household name for themselves. Even though they may have the resources and capability to engage huge market

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

Combination pro

research, this does not mean that smaller enterprises would not have the same success in China market. We have some guidelines on how foreign companies, regardless whether they are Multinational companies (MNCs) or smal

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

l-medium enterprises (SMEs), can enter into China market and gained success thereafter.

1. Understanding the culture

The Chinese culture is a unique culture compared to the rest of the world. Being the only nation wit

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

h the most number of Chinese nationals, China has a rich heritage and history which they are very proud of. Their culture values are what led them to what they have now.

The Chinese are very respectful to each other an

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

d thus, they tend to seek for others’ opinion before settling on a decision. Hence, a Chinese business negotiation would usually take much longer than what the foreign investors usually take in their own countries.

If

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

both parties do not understand each other’s culture, the Chinese would think that the foreign companies are too hasty and impulsive with their decisions while the foreign investors would find the Chinese too long-winded

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

with their decision.

There must be someone communicating the thoughts of the two parties to ensure that the locals and the foreigners have the same understanding of each other’s stand. Thus, most foreign companies wou

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

Following aspects would a

ld either engage a translator or a local organization to be the key link between the locals and them.

2. Establishing a relationship (“guan xi”)

Many companies would have heard of the term “guan xi” which is commonly

dd to the challenges in developing combination products:

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

used in China. The Chinese like to establish a good network in the market as they believe that having good relationships with others would allow them to work more efficiently. The locals prefer to work with others whom

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

they are able to trust and speak their mind freely. Hence, the Chinese often work with companies whom they have “guan xi” with. Furthermore, having a good “guan xi” with the government would allow them with the upper ha

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

nd as they would have a better idea on the correct administrative and registration procedures which they can reduce in waiting time and avoid spending unnecessary cost.

Most of the locals have some kind of “guan xi” 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

th different parties hence, foreign companies would need to develop their business network and learn how to expand their “guan xi” around China.

3. Domestic competition

As more and more foreign investors enter into Ch

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

Professional from academic institutions, pharmaceutical industries, health care indust

ina, the domestic companies are improving as well. Benefiting from the country’s technology advancement and government’s support on knowledge and skills, the local companies are sharpening their marketing tactics and im

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

proving the quality of their products.

Thus, foreign companies should not expect a low-grade competition from the Chinese companies as they tend to have a higher market share due to their brand presence and the appropr

.

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

iate “guan xi”. In addition, the Chinese tend to have an inclination towards their own country’s products as the Chinese have a high sense of national pride.

One way for foreign companies to tackle this issue would be

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

Companies that provide selfless information through particip

to ensure that their products would not appear too foreign to the locals and the foreign companies should try to understand how they are able to either work together with their local competition or to fight against 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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