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There are many resources for information about RoHS compliance on the Internet. It is sometimes difficult, however, to get to a clear and direct answer f

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

or some questions. On March 1, 2007, ‘China RoHS’ became effective, and with that came a flurry of conversation about compliance, who is compliant, what

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

Examples of combination products may in

constitutes compliance, and how that compliance is being implemented. This can make for confusing situations for Distributors who ultimately rely on comp

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

iance and compliance certification from its OEM Suppliers.

When the EU-RoHS Directive (Restriction of Hazardous Substances) took effect in July 2006 the

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

rollout was time consuming, but smooth. It currently appears that most manufacturers are compliant and all old stock has been removed. However, little,

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

Combination pro

if any, attention has been paid to the ‘China RoHS’, “Law of the People’s Republic of China for the Promotion of Clean Production” and the “Law of the Pe

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

ple’s Republic of China on the Prevention and Control of Environmental Pollution by Solid Wastes” and other related statutes. While there is crossover be

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

tween the EU-RoHS Directive and the ‘China RoHS’ Laws they are not identical. Most importantly they require different labeling.

The current practice of

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

most Manufacturers is to provide a letter to its Distributor claiming that products are compliant with China-RoHS. Most Manufacturers refuse to label the

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

product according to the China directives. In these cases, the responsibility is passed on to the Distribution Channel to choose whether they want to be

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

held accountable for marking the product on behalf of the supplier OEM and subsequently take the responsibility for the compliance of the product. Ultima

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

Following aspects would a

tely, it would seem that whoever marks the product would be the one taking responsibility for the compliance of the product.

In a recently issued whitep

dd to the challenges in developing combination products:

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

per by Symphony Consulting, “Transition to RoHS: The Seven Common Pitfalls to Avoid”, the implication is that if a Distributor supplies the product and c

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

ertifies it as compliant and it is later determined that it contains a banned chemical, the manufacturer whose logo appears on the product could be banne

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

d from that country. This could also include severe fines if the non-compliance event is due to negligence and/or willful misconduct.

These implications

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

travel up and down the supply chain for the Distribution Channel. If we certify compliance based on a letter from the supplier OEM and label the product

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

Professional from academic institutions, pharmaceutical industries, health care indust

and if it’s found to be non-compliant, then our contracted relationship could be damaged with our supplier OEM. If we provide to our OEM customer a compo

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

nent product that is certified with a letter and marked by the Distributor but found to not be compliant, the implication is severe for the OEM customer.

.

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

The situation is precarious. Why was the EU-RoHS Directive carried out swiftly and effectively and the ‘China RoHS’ all but ignored? It will be interest

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

Companies that provide selfless information through particip

ing to see how the compliance is handled in the future for ‘China RoHS’ as demand increases.

www.aegis-elec.com

Posted by Carolynn Larson-Garcia, Write

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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Procurement is the purchase of goods or merchandise by a business, association, organization, or an individual. This simply means buying supplies from suppliers at the lowest possible price. The best way of doing this is to let the suppliers contend with each other so that the investment costs of the buyer are kept at a minimum.

IPOs are getting tougher. So what are the options for alternative exit strategies?

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