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.

Monday, December 20, 2010

Drug Regulations Around the World

Depending on which country or continent you are on, the regulations for drug and pharmaceuticals can vary. It is important to know the different regulations from country to country in order to avoid any mix-up or confusion.

For instance, Japan pharmaceutical regulations are detailed but not hard to follow if you understand the basic elements. There are many different departments that are in charge of the drug regulations in Japan, so it is important to understand what each department is in charge of and what their individual policies are. The regulation laws are based in eight separate areas, each dealing with a different topic, such as pharmaceutical safety and law or dealing with the supply and transporting of blood products. The job of these different departments ensure the safety of the public and make sure that the laws and regulations are upheld so that the drugs being manufactured and provided are safe for consumption. Every several years, the laws are rewritten and updated in order to ensure that everything is up-to-date with current health and safety issues, so it is important to make sure that you are familiar with the most recent laws and regulations. Regulations in Japan dictate that the drugs being created and manufactured there must go through several clinical trials in order to determine their effects and effectiveness.

Like Japan, Mexico also has its own rules and regulations dealing with drugs and the export and import for drugs. If exporting a drug to Mexico, that drug must be registered with a host pharmaceutical company, meaning that a local pharmacy must hold the sanitary license for that drug. This is an important thing to remember because it requires months of paperwork and permits.

In India, one company regulates the production, distribution, consumption and prescription of drugs. This is beneficial because instead of having dozens of different branches that are constantly trying to keep up with one another, there is one unit providing the information and keeping track of everything. However, this can also lead to some disadvantages, because the individual often slips between the cracks and it is difficult to keep track of everyone involved in the drug industry. Therefore, it is possible for drugs to be purchased and consumed without the taker needing the advice of a licensed practitioner. It is important to make sure that all paperwork is in order, in order to avoid miscommunication.

Wednesday, December 15, 2010

Drug Approval Policies in China and the Growing Pharmaceuticals Market

A Growing Market

In 1998, Chinese pharmaceutical sales exceeded RMB 110 billion. By 2003, sales had reached nearly RMB 300 billion, and by 2007 had grown to almost RMB 600 billion. In the wake of the creation of the State Food and Drug Administration, sales have continued to climb at an almost exponential rate. The Chinese drug market is now the third largest in the world.

Drug Approval

The State Food and Drug Administration handles China drug approval matters, which was created in April of 2003. This agency was founded to raise Chinese pharmaceutical products to the quality standards of other countries and enhance Chinese standing within the World Trade Organization, as well as monitor the quality of foreign imports. By creating a regulating body to monitor the quality and effectiveness of domestic and foreign pharmaceutical products, China had positioned itself to be an important player in the worldwide pharmaceutical landscape.

Some of the responsibilities of the Chinese State Food and Drug Administration include:

  • Monitoring drug usage for adverse reactions
  • Creating and maintaining a state drug catalogue
  • Investing and punishing the production of illegal counterfeit drugs and inferior drugs
  • Overseeing the registration of pharmacists through a state licensing system
  • Creating a 'best practices' system for drug research and development
  • Approval of pharmaceuticals and medical devices for public sale

The State Food and Drug Administration mandates that foreign pharmaceuticals intended for sale within China must first meet regulatory approval in their country of manufacture. The exception to this rule is when a drug product critically needed in China has not met with home-country regulatory approval. In those circumstances, the State Food and Drug Administration can conduct an independent review of the safety of the pharmaceutical and approve or disapprove it for public use.

Foreign Interest in the Chinese Drug Market

Bloomberg reports that the Bayer corporation plans to double sales in China by 2015 and move their production operations of polycarbonates from Leverkusen, Germany to Shanghai, China by 2011. The new plants will have an annual production capacity of 200,000 metric tons.

In February 2010, Pfizer, Inc moved its R&D operations from Connecticut to Wuhan, China. AstraZeneca, of England, soon followed suit and has committed to moving its production to China, as well. Novartis has invested more than $1 billion in expanding its China operations.