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In theory every Planning Application should be supported with a design statement. This is simply a written document that explains certain aspects of the desig

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

n and why it is required including the clients needs.

The advice of Planning Policy Guidance: General Policy and Principles (PPG1) is that all applicants should be able to demonstrate how they have taken account of the need for good design in t

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

Examples of combination products may in

eir development proposals.

However, most small scale developments do not require a separate design statement to support a Planning Application as most issues & principals can be demonstrated on the actual drawings. Regretfully, Local Planning A

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

uthorities are under increasing pressure from Central Government to have this written support statement with applications & complicated or contentious schemes usually require a design statement in any case.

How will a Design Statement help?<

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

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It will help the Council, Councillors, neighbours, the public to: understand fully your proposals and the principles of the design; consider the proposals against design policies in the Local Plan; consider the proposal against design object

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

Combination pro

ives in Planning Policy Guidance Note 1 from which the Design Statement requirement comes.

There are three essential steps to producing a Design Statement and these are:

Step 1 - site analysis and evaluation.

This is a factual account,

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

which should be essentially based upon drawings and sketches explaining the site within its context, e.g. urban, residential, conservation area, sloping, industrial, vegetation etc. It is important that this analysis has its basis in fact and re

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

ason rather than opinion and should include: building styles and sizes, street patterns, the nature of spaces between buildings and their uses, the character of the area, proximity to Listed Buildings, etc.

An explanation of the constraints and

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

opportunities the site has in terms of its design, e.g. important views, features worthy of retention or protection, features which are detrimental and need to be addressed, and an explanation of the constraints and opportunities the site has

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

in terms of its context, e.g. local building, changes of levels, physical features such as underground services, drainage systems, overhead powerlines, service trenches, trees, ecology and wildlife habitats etc.

Step 2 - Identifying the desi

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

n principles

These should be the main criteria that the design needs to fulfil. These principles should be so important that they are not easily changed. They should not be a list of preferences but a clear list of what needs to be included

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

Following aspects would a

in the design and should remain consistent irrespective of any approach taken. These principles may also include critical constraints to the applicant such as minimum floor space to be achieved, the importance of signs to a commercial proposal,

dd to the challenges in developing combination products:

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

financial constraints, etc. It should also include principles that are a requirement of the Council as may be set down in Local Plans and Development Briefs or other Guidance Notes.

It is important to understand that each site and proposal is u

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

nique and there is no right or wrong set of design principles.

The design principles should clearly relate to the site analysis and evaluation findings. The design principles will vary in number and complexity from proposal to proposal.

For ex

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

ensions or alterations to dwellings it is likely that there may be only one or two principles, e.g. the extension should be designed to be sympathetically related to the existing property and not to cause harm to the neighbour.

In more complex

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

proposals, design principles may include the retention of important public views, mass and scale of buildings should be similar to those in the street or conversely a new building ought to be larger because of the relationship of the site to ne

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

Professional from academic institutions, pharmaceutical industries, health care indust

ghbouring buildings. Important trees may need to be kept or the buildings may need to face a particular way or be in specific positions to meet the needs of industrial activities etc.

Step 3 - Creating the design solution.

The third sta

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

ge is to produce the design solution. The important factor is that the design solution should incorporate the design principles, which in turn can be justified against the site analysis and evaluation.

So what will a Design Statement look li

.

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

e?

There are no set rules or ways of presenting a Design Statement. Much depends upon the scale and nature of the development proposed. It should first comprise a detailed site analysis based upon drawings and sketches setting out the const

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

Companies that provide selfless information through particip

raints, opportunities and design principles. Written statements alone may not be enough and photographs of the site and its surroundings can be helpful. The Statement should relate to the wider context of the site and not just to the site itself

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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Delicious - Planning Permission Tips UK: The Value of Design Statements When Submitting a Planning Application

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