2011/1/20
2010/10/7
2010/9/27
Japan GMP 2007 (108 pages)
1. 変更管理システムに関する提言;
2. Science and Regulatory Studies at National Institute of Health Sciences;
3. Current Japanese Regulations and Implementation of ICH Q8-Q10;
2. Science and Regulatory Studies at National Institute of Health Sciences;
3. Current Japanese Regulations and Implementation of ICH Q8-Q10;
2010/5/10
CPHI Worldwide 2010
The CPHI event was first held in 1990 and 2010 marks the 21st year of this prominent and industry-leading occasion. From just 250 delegates at the initial convention, visitor numbers have steadily grown from more than a few hundred visitors to well over 25,000 people. Hosting over 1,400 exhibitors, the event now covers more than 50,000 square meters of exposition space. Regarding global pharmaceuticals ingredients, it is the main promotion leader in the industry.
This important event gives customers of the industry a chance to meet various manufacturers and discuss their products. Medicine has come a long way and the world is learning more each day. Medical professionals today have the privilege of being able to make the best choices and feel confident in making decisions regarding drugs.
There are many reasons to attend the CPHI Worldwide Event, of course, but it helps to know that visitors from over 125 countries will be attending and this creates a matchless environment where delegates can gather, study, and share thoughts with each other. The wide-range of exhibitors allows visitors to renew existing acquaintances as well as establish new marketable associations. Every year, over 95% of visitors make new business acquaintances and leads. With both recognized businesses and new participants exhibiting, visitors have access to key pharmaceutical ingredients represented by professionals from around the globe, as well as fast-moving and emerging new markets. CPHI includes a conference agenda, speaker’s area, an industry awards presentation and a series of specialist events.
2010/4/20
2010/4/19
TFDA Chief speech TFDA局長康照洲 (mp3)
2010.4.15
兩岸醫藥交流自去年10月由國家生技醫療產業策進會率團拜會大陸衛生部後，雙方都期待在今年的江陳會能簽署實質醫藥協議，為了這項共識，衛生署藥物食品管理局（TFDA）局長康照洲已計劃4月底拜會大陸國家食品藥品監督管理局（SFDA）局長邵明立。
2010/3/31
Ranbaxy, Pfenex ties up for Biosimilar Therapeutic development
インドの製薬最大手ランバクシー・ラボラトリーズ(500359.BY)は29日、バイオシミラーの治療用タンパク質を米フィーネックス（Pfenex、本社：カリフォルニア州）と共同で開発する契約を締結したと発表した。
Ranbaxy Laboratories Limited and Pfenex Inc. announced that Ranbaxy will develop an undisclosed biosimilar therapeutic produced in the Pfēnex Expression Technology™ platform, a Pseudomonas-based recombinant protein expression technology.
Fire Burns Savior Lifetec Factory, Causing $7Mln Loss
カルバペネム系抗生物質メーカーが火事
Savior Lifetec is a Taiwanese manufacturer of carbapenem antibiotics. The fire in the morning of Mar 30th caused USD 7 million loss.
【聯合報╱記者胡蓬生／竹南報導】
苗栗縣竹南科學園區展旺生命科技公司，昨天上午發生火警，大火延燒逾2小時，不斷發生爆炸，巨大火球和濃煙直竄，火勢在10時後逐漸控制，這起火災是竹南園區成立近10年來最嚴重的，廠商損失估計超過2億元以上，但實際財務損失，展旺仍估算中。苗栗縣消防局今天到火場鑑識，調查火警原因。
2010/3/30
The First 2 Biosimilars (Follow on Biologicals) in Japan
Please refer to the new Regulation on Biosimilar in Mar 2009. (Japanese)
There are 2 products in the market now:
The Novartis generics business, Sandoz, launched its recombinant human growth hormone somatropin, Somatropin BS S.C., in Japan. The company says the drug is the first ever biosimilar to be approved and launched in that country, which represents the world’s second largest pharma market.
Reference:
バイオ後続品の品質・安全性・有効性確保のための指針
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