Actual - Legal

The major starting-point was undoubtedly the Commission's White Paper on the completion of

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

the internal market. (White Paper 1985) In this document the Commission presented a thoro

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

Examples of combination products may in

gh study of the various barriers which stood in the way of having a genuinely single marke

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

t, as was (at least to some extent if not entirely) envisaged by the original EEC Treaty.

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

he most ingenious aspect of the White Paper, however, was that the Commission managed to p

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

Combination pro

opose a list of about 300 measures which would enable the Community to complete its intern

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

al market, accompanied by a detailed timetable.

The Commission's approach was endorsed by

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

the European Council, leading to the amendments of the EEC Treaty introduced by the Single

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

European Act. It would go beyond the scope of this introduction to analyze these amendment

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

s. Suffice it to say that according to Article 7a, EC Treaty, 'internal market shall compr

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

se an area without internal frontiers in which the free movement of goods, persons, servic

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

Following aspects would a

s and capital is ensured in accordance with the provisions of this Treaty'. The same provi

dd to the challenges in developing combination products:

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

sion also constitutionalized the target date of 31 December 1992.

The internal market pro

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

ramme has been surprisingly successful. The large majority of the measures of which the pr

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

gramme was made up have been adopted in time. Admittedly, there are areas which lag behind

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

(such as free movement of persons). Moreover, it has not always been possible to maintain

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

Professional from academic institutions, pharmaceutical industries, health care indust

the rigorous approach originally advocated by the Commission, and a lot remains to be done

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

with regard to implementing the adopted measures at national level. Nevertheless, the esse

.

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

nce of the internal market is in place, which finds perhaps its most spectacular expressio

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

Companies that provide selfless information through particip

in the complete abolition of controls at intra-Community borders on the movement of goods

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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