Advice You - Business

Goods and services produced in one part of the world are increasingly available

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

in all parts of the world. International travel is more frequent and internation

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

Examples of combination products may in

al communication is commonplace. International travel has been boosted by a grow

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

ng airline industry and many persons now travel abroad for both business and lei

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

sure. The airline industry also facilitates the quick movement of migrants and c

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

Combination pro

untries such as Canada can be considered ethnic and cultural melting pots due to

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

their significant migrant communities.

There has also been a push for politica

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

l integration as nations seek to ensure their economic future through a collabor

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

tive effort. The rise and strengthening of regional bodies such as the European

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

Union (EU), the Caribbean Community (CARICOM) and the North American Free Trade

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

greement (NAFTA) are prime examples of countries coming together for a common go

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

Following aspects would a

al.

These regional groups all espouse the concept of closer ties and initiative

dd to the challenges in developing combination products:

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

s such as a single currency and the free movement of the citizens of member stat

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

s between these states are items at the fore. We have already seen the introduct

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

ion of the Euro as the single currency of most EU member states and CARICOM is i

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

to the launch of its new integration initiative, the Caribbean Single Market and

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

Professional from academic institutions, pharmaceutical industries, health care indust

Economy (CSME).

The most exciting change the CSME is intended to introduce was

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

to for the first time make it lawfully possible for capital, skills and people

.

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

o move freely in the region. The trade in services was facilitated and Caribbean

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

Companies that provide selfless information through particip

citizens were enabled to establish enterprises wherever they wish in the region

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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