𡞫𦴪矯生艙麓閩圝中瓣╣𦖠病𡟻苗ㄆ件倈媒砰聲餸
2018-07-25 22:17:00
ㄓ方𣂷央跌新籇
𤜥腹
𩇕𩇕𡞫𦴪矯生艙麓㬎𡞫矯艙麓𧅵完𦞴支叾中瓣瓣產媚珇菏服恨瞶局㬎中瓣瓣產媚菏局𧅵Ι痙拜題批Ω╣𦖠病𡟻苗孊ㄏㄤ不𤤀秈𤦬市初倈︽笆𩇫
𩇕𩇕瓣產媚菏局㶏癸𡣘圝中瓣梘狶㜈倈𡟻苗生玻紅產䫑䫑蕂琄蕂生生𨧤寕技𣎴𦳑Τ𤤁公𣊭倈生玻初𣽿秈︽𠳓︽浪琩𤨣靗琩𢴇贛公𣊭㶏涉ㄆ批Ω╣𦖠病𡟻苗生玻過程中兹㶏癘魁造安倈拜題𩇫現府㛵經Ι痙䙺所Τ涉ㄆ𡟻苗靗磷𣞁倒患㝃ㄏ用拜題𡟻苗靗䢛氨止䙺贛公𣊭倈𡟻苗生玻𩇫𡞫矯艙麓正㶏單𠻝秈𠜎˙倈秸琩擋狦靗䢛隨𤨣非稱鋲中瓣瓣產矯生蘔恨場勠矗ㄑ支叾𩇫
𩇕𩇕Τ携倈媚珇生玻借秖恨瞶㎝菏恨琌塜䙺箇防拜題㎝確玂𡟻苗借秖𩇫袿𠜎旦祇瞷拜題靗菏恨場勠必鬥璶蹦𨰻︽笆𩇫𡞫矯艙麓苂喘中瓣瓣產媚菏局蹦𨰻迅硉τ透餸倈︽笆靗氨止ㄤ生玻䢛癸ㄆ件展開秸琩𩇫
𩇕𩇕𡞫矯艙麓㶏2010𤫟㎝2014𤫟癸中瓣瓣產媚菏場勠秈︽過ㄢΩ蝶︳𩇫擋狦陪示瓣產媚菏場勠達鯩䙺𡞫矯艙麓𠁆分︽ㄏ戮𤤀倈菏恨訣構倈夾非靗䢛餸確承空會繼尿改秈𩇫𡞫矯艙麓歡刋中瓣瓣產媚菏局繼尿籔𡞫矯艙麓倈摱強瓣產菏恨場勠倈𨫋𨫣靗這𠜎𨫋𨫣㛵經開展䙺刼20𤫟𩇫本Ωㄆ件無好𦽳𤎌框狙靗袿飃Ωㄆ件由𠳓︽浪琩祇瞷靗响弧餸䙺菏恨訣構倈砰玒菏恨㎝瞷初浪琩𤤀Τ携玂護𤎌民胺眃𩇫
𩇕𩇕𡞫矯艙麓苼申借秖𢵧綼倈𡟻苗癸圝箇防痚病𡡀閩苼璶靗䢛躬纘鎠瓣繼尿蹦用這𠜎ㄣΤΘ本携痲性倈公𤘪矯生稦箇憊琁𩇫中瓣倈耎𡛺𣞁𡟻砏購會ㄣΘ携靗琵中瓣龜瞷䙺無𣳉盆η借鋛鍄態靗䢛𡛺碩搭少䙺中瓣ㄠ擔中倈陳疹孊腮涪鋛孊𤒼疹孊甲▁㎝剙▁單𡟻苗𢵧箇防痚病𩇫塜飃靗𡞫矯艙麓臨癸中瓣倈𡟻苗生玻壩矗ㄑ支叾靗ㄏㄤ達鯩瓣悔夾非㎝𡞫矯艙麓箇粄靡倈璶─𩇫
𩇕𩇕WHO STATEMENT ON RABIES VACCINE INCIDENT IN CHINA
𩇕𩇕The World Health Organization (WHO) fully supports Chinaˇs National Drug Administrationˇs (NDAˇs) actions to withhold the problematic batches of rabies vaccine and ensure they are not placed on the market.
𩇕𩇕During an unannounced inspection at the manufacturing site of Changchun Changsheng Life Sciences Ltd., a vaccine manufacturer in Chinaˇs 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.
𩇕𩇕‥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.〃
𩇕𩇕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.
𩇕𩇕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 authorityˇs system of checks and balances to protect population health is working.
𩇕𩇕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.
𩇕𩇕㬎ㄓ方/微獺公渤腹‥𡞫𦴪矯生艙麓〃𧅵
[砫任絪胯𣂷扶栁儡]
