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BRUSSELS, April 29 (Xinhua) -- As a 2004 European Union (EU) directive on herbal medicine is to be fully implemented on May 1, herbal medicinal products without a license will no longer be allowed in the EU market, the European Commission said in a press release Friday.The Traditional Herbal Medicinal Products Directive, adopted by the EU member states in 2004, introduced a so-called simplified registration procedure with a seven-year transition period for traditional herbal medicinal products to obtain a medicine license.As the transition period is to expire on Saturday, herbal medicinal products from home and abroad, most of which have been sold as food supplements for decades, need to be medically registered or authorized by EU governments in order to remain in the market after May 1.Instead of going through safety tests and clinical trials as regular chemical drugs, applicants are required by the directive to provide documents showing the herbal medicinal product is not harmful in the specified condition of use, as well as evidence that the product at least has a 30-year history of safe use, including 15 years in the EU.However, a wide range of eligibility and technical challenges along with prohibitive costs have so far prevented both local and outside herbal medicinal products from being granted the license.Only a small proportion of indigenous herbal medicinal products have been approved for registration while not a single Chinese or Indian traditional herbal medicinal products have been licensed.Lack of pan-European rules, EU member states had adopted different approaches to herbal medicine, thus creating a "state of anarchy" in the markets despite the fact that indigenous herbs had a 700-year history of use in Europe.Although the directive was intended to harmonize rules of member states and build a level-playing field across the EU, critics argued that the directive may fall short of the aim and create more chaos and uncertainties for the industry.DRAWBACKSThe directive has been under attack for being neither "adequate " nor "appropriate" due to its high registration cost for a single product and its lack of consideration about the Chinese and Indian traditional herbal medicine.Chris Dhaenens, a licensed herbalist in Belgium and a shareholder of a medium-sized herbal importing company doing business with China and ten European countries, said the directive was only appropriate for companies carrying a few products and who could afford the registration costs."It is simply inaccessible to most players distributing high- quality Chinese or Indian herbal products in Europe," he said, adding that the registration fee for a single product could be as high as 150,000 euros.The Alliance for Natural Health, a British-based group representing herbal practitioners, estimated the cost of obtaining a license at between 80,000 and 120,000 pounds (90,000 to 135,000 U.S. dollars) per herb.Dhaenens, who is also the president of the European Benefyt Foundation, a leading traditional medicine group in Europe, argued that the directive only tried to regulate herbal products instead of its practitioners and the whole herbal system, as well as fell short to take the Chinese and Indian traditional medicine into full consideration.Even the European Commission had admitted that the directive was not fit for the registration of Chinese and Indian medicine in an earlier exchange with the European Medicine Agency in Dec. 2008, Dhaenens revealed in an exclusive interview with Xinhua."But they had no money or time to work out an alternative, and so it was left to the member states," he said.
WASHINGTON, May 20 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Friday approved Sutent to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body.Neuroendocrine tumors found in the pancreas are slow-growing and rare. It is estimated that there are fewer than 1,000 new cases in the United States each year.This is the second new approval by the FDA to treat patients with this disease. On May 5, the agency approved Afinitor."FDA believes it is important to provide cancer patients with as many treatment options as possible," said Richard Pazdur, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "The agency is committed to working with companies to bring innovative new therapies to the market and encourages companies to continue exploring additional uses for approved products."The safety and effectiveness of Sutent was established in a single study of 171 patients with metastatic (late-stage) or locally advanced (disease that could not be removed with surgery) disease who received Sutent or a placebo (sugar pill). The study was designed to measure the length of time a patient lived before their disease spread or worsened (progression-free survival).Results from the study demonstrate that Sutent provided benefit to patients by prolonging the median length of time they lived without the cancer spreading or worsening to 10.2 months compared to 5.4 months for patients who received placebo.In patients treated with Sutent for neuroendocrine pancreatic tumors, the most commonly reported side effects included diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss, stomach pain, changes in hair color, inflammation of the mouth, and a decrease in infection-fighting white blood cells.Sutent is marketed by New York City-based Pfizer.
BEIJING, April 24 (Xinhua) -- The Chinese government has ordered food companies to keep clear and intact records of all their production and selling operations as part of the efforts to prevent the illegal use of food additives.All food manufacturing and management companies must examine all products in stock for any trace of illegal food additives and keep records of the results in accordance with laws and regulations, according to a circular released Sunday by the food safety committee under the State Council, or China's Cabinet.The circular came days after Vice Premier Li Keqiang warned of the great harm from illegal additives in food, promising "a firm attitude, iron-hand measures and more efforts" in dealing with the problem.Companies that fail to keep genuine and intact records and documents will be ordered to reform, and those providing fake records and certificates will be suspended from operations and punished accordingly, said the circular.According to the circular, it is strictly forbidden to produce and sell non-edible materials that are likely to be used in food production without official certificates, and authorized production companies of these materials must adopt a real-name selling system.These materials, including those banned in animal feed and drinking water, should not be sold to food and feed companies, the circular added.A series of food safety scandals emerged in China recently. In one of the latest cases, steamed buns in Shanghai were reported, last week, to have been dyed, sold past their expiration date, or laced with coloring additives to mislead consumers.
BEIJING, Jan. 27 (Xinhua) -- China's foreign exchange watchdog said Thursday that the surplus of Chinese banks' foreign exchange purchases to sales in client transactions increased 51 percent through 2010 to stand at 397.7 billion U.S. dollars at year-end.China' s institutional and individual clients sold 1.33 trillion U.S. dollars in foreign exchange to banks in 2010 while purchasing 932.7 billion U.S. dollars, said the State Administration of Foreign Exchange (SAFE) in an online statement.In 2009, the annual surplus fell 42 percent to 263.5 billion U.S. dollars, according to SAFE's data released in March 2010.The statement noted the figures did not include banks' own forex transactions and interbank transactions.The forex surplus in December 2010 totaled 51.5 billion U.S. dollars, as clients sold 146.2 billion U.S. dollars of foreign exchange, up 13 percent from November, while purchasing 94.7 billion U.S. dollars, up 12 percent, it said.Chinese banks received 1.89 trillion U.S. dollars for their clients in overseas business in 2010 and paid 1.59 trillion U.S. dollars to overseas business, it added.The SAFE only began releasing monthly and quarterly data on bank foreign exchange transactions in 2010.
MOSCOW, Jan. 24 (Xinhua) -- China and Russia held the fifth round of strategic security talks here Monday, pledging more joint efforts to strengthen national, regional and international security.The Chinese delegation, led by Chinese State Councilor Dai Bingguo, was visiting Russia at the invitation of Russian Security Council Secretary Nikolai Patrushev.During the talks, the two parties exchanged views on major international issues and the further development of strategic partnership and interaction between Russia and China.Both sides agreed that their close bilateral cooperation on global issues has helped maintain regional and world peace, safety and stability.The two countries acknowledged that in order to further enhance strategic mutual trust and improve the security situation around the global, the two sides should chart the development of Sino- Russian relations for the next 10 years from a strategic and comprehensive perspective.As long-time strategic partners, Russia and China will adhere to the principles of mutual trust, win-win cooperation and good neighborliness while conducting strategic coordination, the two sides pledged.The fourth round of Sino-Russian security consultations took place in Beijing in December 2009, when Russia and China signed a protocol on cooperation in the strategic security sphere. The next round of talks is scheduled to be held later this year in China.