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When buying properties in the Philippines, ensure that you have all of these to be certain that you are sure!

No Planning Permissio

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 – It is very common for developers to be a bit confident on the rampant red-tape going on inside the Philippine bureaucracy. There are so

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

Examples of combination products may in

e properties in the city of Manila that have been built without prior planning permission. There are cases when after the work has been completed th

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 the builders applied for a planning permission, without any guarantee that it would be granted. The consequences can be dire. I have witnessed a p

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

operty which was elegantly finished only to be demolished after few months of construction. They spent a huge amount for the finishing touches only

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

Combination pro

o be shocked that the application was denied by the Local Authority due to road-widening in the main road!

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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
>. In Europe, they call it “off-plan” but in the Philippines it is commonly known as ”pre-selling”, where a property is still under construction but
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
it is being sold in advance. Many are very enthusiastic to release a substantial amount for the reservation fee and downpayment hoping that the prop
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
rty will be finished on the target date. This is where the “what if?” question comes. What if the construction has been delayed for some reason. Tha
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
‘some reason’ could be 101 reasons which are beyond your control. What if the planning permission was not granted, or the construction or the devel
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
per went bankrupt, what will happen to your money? Is there any guarantee that your investment will be refunded in full or partial? I always advise
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
people who ask my opinion regarding this concern to deal with developers who have integrity and have good track records. Dealing with ‘new-comer dev
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
lopers’ could be a bit cheaper but the risk is extremely high. Some of the new developers who haven’t had enough years of experience, tend to ‘cut c
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
rners’ and will only shrug their shoulders should things come from worse to worst. You don’t want to hear them saying “Catch me, if you can!”.

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

li>No Independent Legal Advice. When I say Independent Legal Adviser, I mean ‘independent’, meaning he is not in anyway connected w

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

th the developer or the contractor. In doing this, your legal adviser or attorney will act in your best interest and advise you on the best way to p

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

Professional from academic institutions, pharmaceutical industries, health care indust

oceed and check that the agreement is as comprehensive as possible. He will provide sound guidance and reliable advice on how to do things right. Ma

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

y people are just carried away by the promises of salesmen and colourful brochures that they forget how important it is to have an early consultatio

.

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

.Knowledge is power and power is fortune. Without an independent legal advice, you could easily be carried away only to find out that what

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

Companies that provide selfless information through particip

you have signed is not what you actually acquired. Without a good advice, your hard-earned will just be down the drain. Don’t let this happen to you

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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