Monday, February 21, 2011

Import Controversy Can Disappear with Mandatory Inspections

There has been recent controversy about Asian imports containing too much lead and other trace minerals. The area of concern ranges from Asian toy manufacturers to Asian medical distributors. Is this a very serious problem, or have a few bad apples spoiled the entire batch?

Americans, facing serious economic problems at home, have a need to look for reasons that they are in financially difficult times. With high unemployment still a problem and the outlook for a rapid recovery not looking very promising, blame is sometimes put on the large imbalance of trade between Asia and the United States. People believe that because mega-stores like Wal-mart import the majority of their products from China and other Asian countries, that their jobs are lost. There may or may not be truth in that belief, but there definitely is something of an anti-Asian sentiment for those without a job.

It is of course very important that products that can be harmful to our health are not allowed to be put on store shelves and sold. There have been a few examples of toys that have made their way from China to our store shelves only to be tested and found to contain unacceptable levels of contaminants in their makeup. Those toys were quickly pulled from the store shelves, and any that were sold were recalled. Another example of a product that did not meet health standards was toothpaste imported from Asia. That product was inspected and rejected due to its unsafe composition.

America has some of the most stringent health restrictions and requirements for both food and non-food products. The requirements were put in to place by the Food and Drug Administration (FDA) as well as other government agencies in order to protect the general public from dangerous products. However, we may have extra strict rules that the rest of the world does not adhere to, and what would be disqualified in the United States might be perfectly acceptable in another country.

The key to this problem is to work more closely with Asian exporters before they ship their products to the United States. When contracts between the overseas companies and the United States are drawn up, one of the conditions that should be included is a clause requiring the product to be inspected and be able to pass a safety inspection. In that way, we can still benefit from cost effective imports and also guarantee that the products will be safe.

Monday, January 24, 2011

How to Successfully Unravel the Drug Registration Process

There are many difficult steps in registering drugs throughout the world. The best thing is to find a company that provides specialized services in registering drugs worldwide. This can quickly unravel the process for you and enable uncomplicated and swift registrations.

A Staff of Experts

A company that can do this for you has dozens of regulatory affairs experts who are also pharmacists, medical scientists, chemists and biologists. These knowledgeable networks of professionals make sure that you have optimal support for all aspects of your drug registration.

It is well worth the extra expense involved in retaining such a drug registration company. Besides offering dozens of qualified personnel to help you in your drug registration process, they can save you valuable time in avoiding mistakes and having to start all over. They can also save you money when their knowledge of registration procedures, including Japan drug registration, helps you cope with the most difficult of registration requirements.

Successful Launches

Many such companies have years of regulatory affairs experience and offer promising strategies to launch your product on the market. They are very familiar with current rules and guidelines for compiling a complete registration dossier either on paper or electronically. For example, they should be aware of mutual recognition procedures in the EU (MRP and DCP), national applications, centralized procedures (CP), DMF and CEP processes, CTAs, variations and renewals to ensure a trouble-free registration for you anywhere in the world.

Human and Veterinarian Drugs

Many of these companies are also familiar with medicinal products for human and veterinarian use, such as NCEs, Generics, ATMPs, biotechnological products, biosimilars and phytotherapeutics, as well as medical devices, food supplements and cosmetics.

Total Peace of Mind throughout Your Drug Registering Process

Besides preparing and submitting your dossier, a drug registration company will supervise the entire process. They will communicate with the authorities and translate product texts into local languages.

A good drug registration company will custom tailor their services to your requirements and meet all your deadlines. All in all, it’s better to have a company whose only responsibility is the preparation and submission of drug registrations than to blunder through the process yourself. Once you successfully launch your new drug, you will be delighted you spared yourself the trouble of the drug registering process.