Advice You - Business

These are the most industrialized countries, however, it will still take some years to form o

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

ut of them a 'real' community with an easy exchange of people and goods.

The total number of

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

Examples of combination products may in

inhabitants reaches today about 500 million inhabitants - an economical factor which can not/

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

should not be disregarded.

Of course the 'old' members, like Belgium, Denmark, Finland, Fran

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, Greece, Ireland, Italy, Luxembourg, Netherlands, Austria, Poland, Portugal, Sweden, Spai

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

Combination pro

, UK and Germany are the driving forces with regard to the further economical development, ho

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

wever, the new members are an additional basis for investment and the general future developm

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

nt of companies from here. This will - in the long run - strengthen as well the 'old' as the

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

ew members.

In order for foreign companies not to miss the chances to partizipate in the 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

wing wealth of this region it is important to go there and to offer its solutions.

Such step

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

should, however, be prepared carefully as there are a multitude of languages and habits in t

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

Following aspects would a

e region.

The best way to do this is the preparation of marketing plans - per country, per p

dd to the challenges in developing combination products:

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

art-region and all of the countries headed for - which contain thoroughly researched figures

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

for the potential of available clients, selling partners and/or possible cooperation partner

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

but also concerning competitors, their marketing ways and furthermore possible market niches

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

which could be supplied due the core-competencies of the specific supplier from abroad.

How

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

Professional from academic institutions, pharmaceutical industries, health care indust

ver, everyone deciding to market in/to Europe should be aware that it takes - depending on th

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

products offered - between abt. 6 and 15 months to reach first results which then can be the

.

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

basis of a permanent success.

Nevertheless, this region is worth every effort as the outloo

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

Companies that provide selfless information through particip

is quite bright and the European Community members all have realized their general potential

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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