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Useful Advices - Security Cooperation-A Business Opportunity For IT and Defence Companies
The US has established a program of Security Cooperation with foreign sovereign nations who share common interest and values to meet common de
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
fence goals. Island Consulting has learnt that the Security Programmes must be authorised by the US Foreign Assistance Act and, as amended, by
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
the Arms Export Control Act to enable the Department of Defence, or commercial contractor, to provide defence services and articles in support
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
of national policies and objectives.
The two key programs within the security cooperation brief are Foreign Military Sales and International
The two key programs within the security cooperation brief are Foreign Military Sales and International
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ilitary Education and Training, (FMS & IMET). The FMF program is managed by the Department of Defence on a not for profit basis. The beneficia
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
country in question has grant aid allocated which may be “spent” against the acquisition of US defence articles in support of security cooper
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
ation.
When required defence articles or services have been identified, in the end user country, the countries representative must provide a
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
Letter of Request normally through the local US Embassy Office of Defence Cooperation representative.
The reply could be in the form of Price
The reply could be in the form of Price
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
and Availability information or a Letter of Offer and Acceptance. If the requesting country accepts the LOA the US will then provide the mater
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
al or services offered.
A wide range of articles may be requested through the FMF program including such things as; Electronic Defence System
A wide range of articles may be requested through the FMF program including such things as; Electronic Defence System
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
, Logistics systems, Support equipment, and training. Training in US military schools can also be available particularly where items being acq
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
uired are similar to those items being transferred through the FMF programme.
As a separate line of Defence Cooperation countries can be offe
As a separate line of Defence Cooperation countries can be offe
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ed support for IMET International Military Education and Training, after making the appropriate request as for FMF.
US companies operating in
US companies operating in
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
the defence field can benefit their European business by taking advantage of these Cooperation programs and implementing IT and Defence system
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
supported by FMF.
It is interesting to see how the US Foreign Assistance is requested at the Congress level as this gives an idea of the pri
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
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
rities assigned to individual recipient nations.
If we limit our interest to Central and eastern Europe we can see that the mature Western na
If we limit our interest to Central and eastern Europe we can see that the mature Western na
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
tions are understandably not offered direct assistance, but the former Eastern European nations have accrued considerable benefit as they brin
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
their Defence infrastructure and systems more in line with western standards. Typically Hungary, Poland and the Czech republic have been bene
.
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
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
icial recipients but this has now moved in favour of countries such as Bulgaria, Romania the Ukraine and most recently Turkey.
By way of exam
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
le Island Consulting understands that in 2005 Bulgaria received approval for $6.9m, Romania $29m and Ukraine $3m whilst Turkey received $33.7m
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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