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世界衛(wèi)生組織(世衛(wèi)組織)完全支持中國(guó)國(guó)家藥品監(jiān)督管理局(中國(guó)國(guó)家藥監(jiān)局)扣留問題批次狂犬病疫苗、使其不能進(jìn)入市場(chǎng)的行動(dòng)。

國(guó)家藥監(jiān)局在對(duì)位于中國(guó)吉林省的疫苗生產(chǎn)廠家——長(zhǎng)春長(zhǎng)生生物科技股份有限公司的生產(chǎn)場(chǎng)地進(jìn)行飛行檢查時(shí)，查出該公司在涉事批次狂犬病疫苗生產(chǎn)過程中存在記錄造假的問題。政府已經(jīng)扣留了所有涉事疫苗，避免給患者使用問題疫苗，并停止了該公司的疫苗生產(chǎn)。世衛(wèi)組織正在等待進(jìn)一步的調(diào)查結(jié)果，并隨時(shí)準(zhǔn)備向中國(guó)國(guó)家衛(wèi)生主管部門提供支持。

疫苗的監(jiān)管極其重要，它是政府確保中國(guó)生產(chǎn)和使用的疫苗安全、優(yōu)質(zhì)和有效的主要手段。這次事件顯示出當(dāng)監(jiān)管有效時(shí)，可以規(guī)避潛在的風(fēng)險(xiǎn)。

有效的藥品生產(chǎn)質(zhì)量管理和監(jiān)管是為了預(yù)防問題和確保疫苗質(zhì)量。但一旦發(fā)現(xiàn)問題，監(jiān)管部門必須要采取行動(dòng)。世衛(wèi)組織贊揚(yáng)中國(guó)國(guó)家藥監(jiān)局采取迅速而透明的行動(dòng)，停止其生產(chǎn)并對(duì)事件展開調(diào)查。

世衛(wèi)組織在2010年和2014年對(duì)中國(guó)國(guó)家藥監(jiān)部門進(jìn)行過兩次評(píng)估。結(jié)果顯示國(guó)家藥監(jiān)部門達(dá)到了世衛(wèi)組織充分行使職能的監(jiān)管機(jī)構(gòu)的標(biāo)準(zhǔn)，并明確承諾會(huì)繼續(xù)改進(jìn)。世衛(wèi)組織歡迎中國(guó)國(guó)家藥監(jiān)局繼續(xù)與世衛(wèi)組織的加強(qiáng)國(guó)家監(jiān)管部門的合作，這一合作已經(jīng)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(fā)現(xiàn)，也說明了監(jiān)管機(jī)構(gòu)的體系監(jiān)管和現(xiàn)場(chǎng)檢查能有效保護(hù)人民健康。

世衛(wèi)組織重申質(zhì)量可靠的疫苗對(duì)于預(yù)防疾病至關(guān)重要，并鼓勵(lì)各國(guó)繼續(xù)采用這一具有成本效益性的公共衛(wèi)生干預(yù)措施。中國(guó)的擴(kuò)大免疫規(guī)劃頗具成效，讓中國(guó)實(shí)現(xiàn)了無脊髓灰質(zhì)炎狀態(tài)，并大幅減少了中國(guó)兒童中的麻疹、腮腺炎、風(fēng)疹、甲肝和乙肝等疫苗可預(yù)防疾病。為此，世衛(wèi)組織還對(duì)中國(guó)的疫苗生產(chǎn)商提供支持，使其達(dá)到國(guó)際標(biāo)準(zhǔn)和世衛(wèi)組織預(yù)認(rèn)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.