DOH Announcement of the amendment of the article 106 of GCP Guideline ( 2010-07-19 ) DOH Announcement of the amendment of the article 106 of GCP Guideline on July 19, 2010 |
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DOH announcement of the guideline for the test of teh electronic and IR thermometers. ( 2009-02-25 ) 公告「臨床電子體溫計」、「紅外線耳溫槍」、「含粉手術用手套」等3項臨床前測試基準草案。
衛署藥字第0980302115號
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DOH announcement of the re-evaluation of pergolide products (01/12/2009) ( 2009-01-15 ) 公告含pergolide成分藥品之安全再評估結果相關事宜。 |
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Regulation of the label of medical device-DOH 12/29/2008 ( 2009-01-07 ) 有關醫療器材產品標籤及包裝之標示規定,詳如說明段,請貴會轉知所屬會員參照,請 查照。 |
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DOH Announcement about the warning sentenct for products with Metformin-12/23/2008 ( 2009-01-07 ) 公告含Metformin成分藥品仿單加刊警語注意事項相關事宜。 |
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DOH Announcement about the "Taiwan Clinical Trial Information Network" and related issues ( 2006-07-07 ) DOH Announcement about the "Taiwan Clinical Trial Information Network" and related issues |
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DOH Announcement about the Regulations on Disclosing Drug Data ( 2006-02-27 ) DOH Announcement about the Regulations on Disclosing Drug Data |
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DOH Announcement about the implementation of amended Article 40-1 & 40-2 of Pharmaceutical Law ( 2005-10-28 ) DOH Announcement about the implementation of amended Article 40-1 & 40-2 of Pharmaceutical Law issued on October 28 |
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DOH Announcement on the 3rd Validation Submission ( 2005-10-28 ) DOH Announcement on the 3rd Validation Submission issued on October 28 2005 |
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Data Exclusivity Period of New Chemical Entity ( 2005-10-28 ) Announcement of the “Data Exclusivity Period of New Chemical Entity” |
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Stage III Validation Requirements ( 2005-10-28 ) Announcement regarding Stage III Validation Requirements |
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The affidavit form of disclosed patent number/ patent application number ( 2005-10-24 ) The affidavit form of disclosed patent number/ patent application number by DOH on October 24, 2005 |
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Guidance on the Informed Consent for Pharmacogenomic Studies ( 2005-10-13 ) Guidance on the Informed Consent for Pharmacogenomic Studies by DOH on October 13, 2005 |
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Stability Test Guideline ( 2005-05-03 ) Stability Test Guideline announced by DOH on April 01 2005 |
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94.02.05 President’s Promulgation on Pharmaceutical Affairs Law Amendment ( 2005-02-15 ) Amendment Promulgation by President Hua- Zong- Yi- Yi- Tze No. 09400017691 issued on February 05th 2005.
To announce the Article 40-1; revise and augment the Article 40-2 |
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Guideline for Toll Manufacturing and Contract Analysis ( 2004-10-31 ) Regulation on the Guideline for Toll Manufacturing and Contract Analysis announced by DOH on October, 2004.
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Regulation on the Application of GMP Certificate ( 2004-12-01 ) Regulation on the Application of GMP Certificate announced by DOH on December, 2004. |
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Regulation on the Reporting of Adverse Drug Reactions (ADR) ( 2004-09-30 ) Regulation on the Reporting of Adverse Drug Reactions (ADR) announced by DOH on Auguest, 2004. |
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Regulation on the Surveillance of Drug Safety ( 2004-10-30 ) Regulation on the Surveillance of Drug Safety announced by DOH on September, 2004. |
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DOH announcement about the amendment of the Pharmaceutical affairs law ( 2004-04-30 ) The announcement of the amendment of the Pharmaceutical Affairs law. |
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