Advice You - Business

1. The Chinese negotiating team tends to concentrate on developing a friendship with the member in yo

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

ur group who is most sympathetic to them. Later, they will pursue all their objectives through that i

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

Examples of combination products may in

dividual, playing on the feelings of friendship, obligation and guilt.

2. Enter negotiations armed w

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

th technical information and records of any previous meetings. Any oversight on your part will be not

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

iced and used against you.

3. You should have a clear sense of your objective and bottom line. Attem

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

Combination pro

ting to discuss your cooperation in "general principles" may give them an impression that you are not

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

ready and your intentions are not serious.

4. During the opening stages of negotiations, the Chinese

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

will try to get your general commitment in their favor. They will not proceed further until they kno

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

your position and attempting to push them forward is usually fruitless.

5. Long term commitment for

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

cooperation will significantly increase your chances for success. The Chinese will be more eager to c

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

mpromise on specifics if they get a broader perspective of cooperation from you.

6. Leave yourself e

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

Following aspects would a

xtra room to negotiate. Chinese are known for their soft sell and hard buy. Substantial concessions a

dd to the challenges in developing combination products:

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

e expected.

7. Try not to ask direct questions. Remember that your counterpart most probably is not

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

he decision maker. Be sensitive while disagreeing so as not to cause hurt feelings.

8. An agreement

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

for the Chinese does not mean the end of negotiations. They will not hesitate to open the discussion

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

f some issues you thought had been resolved.

9. It is best not to emulate the Chinese style of negot

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

Professional from academic institutions, pharmaceutical industries, health care indust

ating. It is easy to be trapped by an illusion that you understand them and their culture. Keeping to

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

your own style usually brings better results and appreciation.

10. Negotiations often involve more

.

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

han task management issues. Developing the personal relationship is achieved through business enterta

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

Companies that provide selfless information through particip

nment. The dinners, the trip to the Great Wall, and so on are all part of developing the relationship

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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