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International trade has become increasingly important to the world economy as well as th

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

e U.S. economy. Trade accounts for about 25 percent of U.S. and world gross domestic pro

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

Examples of combination products may in

uct (GDP). It is growing at twice the rate of any other economic sector. In terms of the

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

United States, one-third of the small firms that make an exportable product and would li

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

e to export do not presently export what they manufacture. Of the small U.S. firms that

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

Combination pro

o export, nearly two-thirds export to only one country.

The international flows of good

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

and capital that underlie international finance are critically important to the well-be

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 of the world's nations. United Nations statistics show that the ratio of world export

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

to total gross domestic product has consistently increased since 1970. Much of this gro

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

th in world trade can be attributed to the liberalization of trade and investment becaus

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

of reductions in tariffs, quotas, currency controls, and other restrictions on the flow

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

Following aspects would a

of international payments. In addition, the advances in communications and transportatio

dd to the challenges in developing combination products:

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

facilities and their concomitant reductions in cost have also facilitated the growth in

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

international trade. Much of the trade liberalization has been accomplished by the imple

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

entation of several regional economic agreements and organizations.

Several regional ec

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

nomic agreements or organizations have been established since the end of World War II fo

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

Professional from academic institutions, pharmaceutical industries, health care indust

the purpose of facilitating an expansion of trade. The governments involved in these ef

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

orts have recognized the value of expanded trade. Some of these blocs have committed to

.

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

he major objective of reducing or eliminating trade barriers such as tariffs and quotas.

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

Companies that provide selfless information through particip

Others have gone further and have established political as well as economic institutions

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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