CHINA HEALTH SCIENCES NEWSLETTER
Vol. 4 , No. 4 - February 20, 2003
TOPICS THIS ISSUE:
New Law: Major changes to China's Drug Registration Procedure (Part 1)
- Drug Maker is under fire in Virus Case
- Medicine Price Hikes get curbed
- ANTIANGIOGENESIS: Bacteria delivers endostatin directly to targeted tumors
- China to Vaccinate all Babies against Hepatitis B
- China's Pharmacuetical Industrial Output Value Rises 17% Jan -Nov
Major changes to China's Drug Registration Procedure (Part 1)
This is the first installment of a 2-part review of China's new Drug Registration Procedure (DRP) which came into effect on December 1, 2002.
Among the significant changes that has occurred in the Chinese Pharmaceuticals sector due to the DRP is the change in the definition of the term "new drug". The DRP also makes fundamental changes to the approval system and management of drug quality and imports, and establishes systems of drug re-registration and monitoring.
The Chinese State Drug Administration has based the new Drug Registration Procedure on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) requirements concerning lack of discrimination, market-opening, equal trade and balance between rights and responsibilities.
As well as new drug approvals, the Procedure's 18 chapters (208 articles) deal with biotechnology products, protection of new drugs, technology transfer and rules governing imports.
Under the Drug Administration Law of 1985, new drugs were defined as those which had not been produced in China, but this is now changed to mean those which have not previously been sold in the country. Applications for drug registration are now classified as either:
1. New drug applications: Drugs which have not previously been marketed in China, or those that have but are to be made available with a change in dosage or administration route, or in a new combination formulation;
2. Abbreviated applications: Products for which the state has already established standards, including previous generic applications and imports; for the latter, the application should be handled by the foreign manufacturer's offices in China or its registered agents in the country. This procedure is also to be used for approval of the raw materials, preparations and extractions of traditional Chinese medicines; or
3. Supplementary applications: Proposals to change, make additions or cancellations to, or withdrawals of, products which have already been approved under either of the above application procedures.
(Source: Pharma Marketletter)
Drug Maker is under fire in Virus Case
Pharmaceutical company F. Hoffmann-La Roche Ltd. may be the latest victim of a mysterious virus that has killed at least five people and sent hundreds more to hospital in Guangdong Province this month.
The company is facing a public relations nightmare and government investigation over media allegations it exploited the tragedy to boost sales of one of its drugs, called Tamiflu.
The Guangzhou-based Southern Metropolis Daily published stories on Saturday and yesterday alleging a recent promotional campaign by Roche might have violated Chinese drug laws and helped whip up public panic over the mysterious virus.
The virus that killed at least 5 people with pneumonia-like symptoms created panic buying of antibiotics and white vine-gar (which many Chinese believe works as a disinfectant and helps protect against disease) began at the start of Spring Festival - around February 1 - but the government didn't hold a press conference to calm the public until February 11, by which time rumors that hundreds had died were spreading rapidly in the province through mobile-phone short messages and the Internet.
On February 9, Roche held a press conference in Guangzhou, capital of Guangdong, to promote its anti-viral treatment for influenza, Tamiflu. Besides telling the media that the drug was sold out in Guangzhou, the company also mentioned, "doctors suspect the virus attacking Guangzhou might be the chicken flu."
Following the press conference, rumors spread quickly that the virus was the chicken flu, which could be killed by Tamiflu. Subsequently, sales of the drug, which had been lackluster since it arrived in China in 2001 due to its high price of RMB 59 (US$ 7.10) for two capsules, suddenly skyrocketed.
It is reported that the Guangzhou municipal government has begun an investigation into the Roche's media conference and subsequent events to see if Roche broke drug regulations by improperly promoting Tamiflu, a prescription drug the company is not allowed to advertise in the mass media.
Meanwhile, Roche said it has also started its own investigation into the matter but declined to give further details. "Roche retains the right to file lawsuits against those who spread rumors in the name of Roche," the company said in a statement.
An executive with the Shanghai Drug Administration said Roche's press conference might not have broken the laws by promo-ting Tamiflu to the Guangdong media. However, "Roche might have sidestepped the law by promoting its prescription drugs at the press conference instead of placing advertisements directly in the media," said Yue Wei, an official with the drug administration.
(Source: Shanghai Daily news)
Medicine Price Hikes get curbed
The pricing watchdog in Guangdong province is stepping up its supervision on the price of antibody medicines, according to central government officials.
"The local governments in Guangdong Province and its neighboring Fujian Province have already introduced temporary inspectors to curb price hikes caused by speculation," said Li Lei, director of the Pricing Supervision Department under the State Development Planning Commission.
Since the beginning of the outbreak of pneumonia carried by unidentified viruses, many Guangdong residents have scrambled for antibody medicines. It is reported speculators in some regions have been selling medicines at prices many times higher than the government-stipulated retail ceilings.
"Any unauthorized price hikes of medicines should be seriously punished," said Li. Apart from gaining illegal profits, the speculators have helped whip up panic among the public, Li added.
Ten hospitals nationwide, including the Beijing-based Jiuxianqiao Hospital, were named and shamed for selling medicines at prices higher than the government ceilings or for other wrongdoings.
The commission is authorized by law to check on price irregularities.
Li said China has launched three massive campaigns to curb medicine price irregularities since 1998.
(Source: China Daily)
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Medical researchers in China have proposed an innovative new way to deliver endostatin gene therapy to solid tumors with a select strain of bacteria.
Endostatin is a natural inhibitor of angiogenesis. Researchers have proposed that bacteria may be feasible for ferrying endostatin genes directly to intended tumor targets. "We selected a strain of Bifidobacterium adolescentis (B. adolescentis) as the delivery system to transport endostatin gene to solid tumors," said Xi Li and coauthors, Nanjing University, Nanjing, China.
"B. adolescentis were only found in the tumors and no bacilli were found in other normal tissues," Li and colleagues reported.
In addition, they determined the therapy had inhibited angiogenesis, which subsequently caused tumor growth to cease.
The central government will spend RMB 36 million (US$ 4.3 million) annually over the next three years to ensure all babies are inoculated against hepatitis B, a major killer that has infected about 10% of China's 1.3 billion population.
The money will enable central and western China, in particular, to inoculate children against the virus. Those areas, which are economically backward compared to other regions, currently lag behind the rest of the nation in providing hepatitis B vaccinations.
China will also receive US$ 315 million from the International Vaccine Immunization Federation to support less-developed areas in the campaign during the same three-year period.
Hepatitis B causes 300,000 deaths by liver failure in China every year, according to official figures.
That accounts for almost one-third of the global deaths due to the disease, according to the United Nations Children's Fund (UNICEF).
Severe liver disease, such as liver cancer, is the leading cause of death by disease in China, compared to the United States, where it ranks just 15th, according to Ray Ip, senior adviser for UNICEF.
China currently has 500,000 new hepatitis B patients each year.
Unsterile injections are the main cause of the spread of the virus in China.
China's pharmaceutical industry generated RMB 28 billion (US$ 8.4 billion) in industrial output value in the first 11 months of 2002, up 17% year-on-year. The industrial output is now twice what is was in 1997.
At present, China has 13,265 registered drug wholesalers, and more than 500 store chains with about 30,000 stores.
By the end of last year, 1,470 pharmaceutical enterprises in China had passed GMP certification, while 779 enterprises, which failed to pass the qualification, have left the market.
