世衛組織：曾對中國葯監部門兩次評估 結果都達標

世衛組織關於中國狂犬病疫苗事件的媒體聲明

世界衛生組織（世衛組織）完全支持中國國家藥品監督管理局（中國國家葯監局）扣留問題批次狂犬病疫苗、使其不能進入市場的行動。

國家葯監局在對位於中國吉林省的疫苗生產廠家——長春長生生物科技股份有限公司的生產場地進行飛行檢查時，查出該公司在涉事批次狂犬病疫苗生產過程中存在記錄造假的問題。政府已經扣留了所有涉事疫苗，避免給患者使用問題疫苗，並停止了該公司的疫苗生產。世衛組織正在等待進一步的調查結果，並隨時準備向中國國家衛生主管部門提供支持。

高力博士

世界衛生組織駐華代表

疫苗的監管極其重要，它是政府確保中國生產和使用的疫苗安全、優質和有效的主要手段。這次事件顯示出當監管有效時，可以規避潛在的風險。

有效的藥品生產品質管理和監管是為了預防問題和確保疫苗品質。但一旦發現問題，監管部門必須要採取行動。世衛組織讚揚中國國家葯監局採取迅速而透明的行動，停止其生產並對事件展開調查。

世衛組織在2010年和2014年對中國國家葯監部門進行過兩次評估。結果顯示國家葯監部門達到了世衛組織充分行使職能的監管機構的標準，並明確承諾會繼續改進。世衛組織歡迎中國國家葯監局繼續與世衛組織的加強國家監管部門的合作，這一合作已經開展了近20年。本次事件無疑令人遺憾，但此次事件由飛行檢查發現，也說明了監管機構的體系監管和現場檢查能有效保護人民健康。

世衛組織重申品質可靠的疫苗對於預防疾病至關重要，並鼓勵各國繼續採用這一具有成本效益性的公共衛生乾預措施。中國的擴大免疫規劃頗具成效，讓中國實現了無脊髓灰質炎狀態，並大幅減少了中國兒童中的麻疹、腮腺炎、風疹、A肝和B肝等疫苗可預防疾病。為此，世衛組織還對中國的疫苗生產商提供支持，使其達到國際標準和世衛組織預認證的要求。

WHO STATEMENT ON RABIES VACCINE INCIDENT IN CHINA

The World Health Organization (WHO) fully supports China』s National Drug Administration』s (NDA』s) actions to withhold the problematic batches of rabies vaccine and ensure they are not placed on the market.

During an unannounced inspection at the manufacturing site of Changchun Changsheng Life Sciences Ltd., a vaccine manufacturer in China』s northeastern Jilin province, the NDA discovered problems of data integrity in the production of the batches of rabies vaccine. Authorities have withheld all vaccines involved, to prevent their reaching patients, and suspended production at the company. WHO awaits the results of further investigations and stands ready to provide support to national health authorities.

「Regulatory oversight of vaccines is critically important. It is the government"s primary method of ensuring that the vaccines produced and used in China are safe, of good quality and effective,」 said Gauden Galea, WHO Representative for China. 「This incident shows that when regulatory oversight works well, potential risks can be averted.」

Good manufacturing and regulatory practices are designed to prevent problems in the process of ensuring quality vaccines. But when problems are found, the regulator must take action. WHO commends the quick and transparent actions taken by China NDA to suspend production at the company and investigate these incidents.

WHO assessed the national regulatory authorities in 2010 and 2014, and found that they met WHO criteria as a functional regulator for vaccines with a clear commitment to continual improvement. WHO welcomes the fact that China"s NDA continues to work with WHO"s Regulatory Systems Strengthening program, as it has been doing for nearly 20 years. While the current incident is clearly regrettable, the detection of this event by an unannounced inspection shows that the regulatory authority』s system of checks and balances to protect population health is working.

WHO reiterates that quality-assured vaccines are critical for disease prevention and urges countries to continue using this cost-effective public health intervention. The Expanded Program on Immunization in China has brought results. It has made China free from polio and significantly reduced vaccine-preventable diseases such as measles, mumps, rubella, and hepatitis A and B among children. To that end, WHO is also supporting vaccine manufacturers in China to ensure that they comply with international standards and meet WHO Prequalification expectations.

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