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Even before Canada grew to include the colorful and distinctive population it does, it was

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

unusual in the fact that it is an officially bilingual nation. The French colonists were

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

Examples of combination products may in

he first to carry the name ‘Canadians;. Today Montreal is the second largest French speaki

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

g city in the world after Paris. There are large concentrations of French speaking Canadia

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

s throughout the entire country. Acadian residents in the bilingual province of New Brunsw

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

Combination pro

ick speak the French language of the first Atlantic Canada settlers.

Canada is also proud

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

of its multiculturalism. After all the Native cultures are the only truly indigenous cultu

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

es of Canada. However, less that one million people identify themselves exclusively as mem

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

ers of the North American Indian, Inuit or Metis Aboriginal groups. Ontario has the highes

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

t concentration of Aboriginal people, nut the Northwest Territories has the highest propor

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

ion with 60 percent of its population being of Aboriginal descent.

All other Canadians im

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

Following aspects would a

igrated from elsewhere whether it was hundreds of years ago or just recently. Much of the

dd to the challenges in developing combination products:

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

Canadian population is made up of British descendants. Almost four million Canadians are S

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

cottish or Irish ancestry. Other major groups are German, Italian, Ukrainian, Dutch, Greek

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

Polish, Portuguese, Scandinavian – literally every nationality imaginable. More recently

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

sians, especially Chinese immigrating from Hong Kong, Latin Americans and people from the

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

Professional from academic institutions, pharmaceutical industries, health care indust

aribbean have been immigrating in larger numbers.

Canada also receives refugees from all

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

over the world. Most newcomers head to the larger cities. Toronto, as a result, is one of

.

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 most cosmopolitan cities in the world.

In 1988 the multicultural character of the coun

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

Companies that provide selfless information through particip

ry was officially recognized when the Government of Canada passed the Multiculturalism Act

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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