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International trade can be broadly termed as exchange of goods and services between two countries or across two intern

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

ational boundaries. Trade between nations existed from ancient times. International trade often had a significant infl

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

Examples of combination products may in

uence in determining the socio-economic, political and cultural scenario of a country.

International trade between tw

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

o countries is heavily influenced by the existing bilateral relations between the nations. During the early times, int

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

ernational trade was strictly regulated and was under the influence of high tariffs. During this period, countries mai

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

Combination pro

ly adopted the policy of mercantilism where the inflow of capital determined the prosperity of the nation. However, wi

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

th the advent of globalization and industrialization during 19th century, these regulations have been relaxed and the

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

concept of free trade has been adopted. In this model, the trade is not regulated by any government-imposed restrictio

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

ns which include taxes and tariffs. All the developed and economically powerful nations including United States, Unite

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

d Kingdom and the entire Europe have been the strongest advocates of this policy.

There are several theories in pract

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

ce for the purpose of determining the tariffs and patterns of international trade. These include the Ricardian model,

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

Following aspects would a

Heckscher-Ohlin model, Specific factors and the Gravity model. However, the gravity model of trade presents a more det

dd to the challenges in developing combination products:

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

ailed analysis regarding the trading patterns around the globe. In this model, the geographical distance between the c

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

ountries and their economic sizes are considered while making the analysis.

In the current scenario, international tr

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

ade is mostly regulated through the guidelines established by World Trade Organization. But, the trade between two cou

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

tries is also influenced by the economic treaties between the countries. Some of these agreements include NAFTA betwee

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

Professional from academic institutions, pharmaceutical industries, health care indust

n US, Canada and Mexico, European Union between 27 countries in Europe and MERCOSUR in South America.

Inspite of all

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

the regulations involved in the process, international trade still offers several potential risks at the economic and

.

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

political fronts. Some of these include cancellation of international export or import licenses, risks involved due to

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

Companies that provide selfless information through particip

war, risk of imposing a ban on imported products after the shipment of the consignment and currency exchange controls

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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