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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DOH announcement about the Proposal for Monitoring and Controlling NHI Reimbursed Drugs and the operation of random surveys. ( 2004-02-26 )
The BNHI Announcement of the Proposal for Monitoring and Controlling NHI Reimbursed Drugs and the operation of random surveys”. |
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DOH announcement about the executive party of the project of "the Audition of the DOH ADR Fund Collection". ( 2003-12-30 )
The DOH commissions the Chien-Chi (EN Wise) United Accounting Company as the executive party of the project of the “Audition of the DOH ADR Fund Collection”. |
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Clarification of the Overseas Site Inspection. ( 2003-11-26 )
In reply to the IRPMA's suggestions on overseas site inspection issued by DOH on September 15, 2003. |
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Clarification of Stage II Validation Documentation ( 2003-11-21 )
To amend the paragraph II of the letter issued by the DOH on May 20th 2003, as "presenting licenses issued by 10 advanced countries with specification of GMP manufacturers or licenses issued by the European Agency for the Evaluation of Medicinal Products (EMEA) with specification o f GMP manufacturers announced by DOH on November 21, 2003. |
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Clarification of the Priority of Site Inspection. ( 2003-09-15 )
Clarification of the Site Inspeciton Priority announced by DOH on September 15, 2003. |
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