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.