Regulations for Registration of Medicinal Products Article 21
Validation requirements for medicinal product are described as follows:1.When applying for drug review and registration, the applicant may firstly prepare the analytical method validation report and the protocol of the validation of critical manufacturing processes. After receiving approval, the manufacturer should conduct validation studies on three consecutive batches of products. If the results meet all specified criteria, the product can therefore be marketed.2.The validation studies should be able to assure drug effectiveness and safety and comply with the Guidelines on GMP Validation Requirements as announced by the central heath competent authority.3.The contents and schedule of a drug validation process are as follows:(1)Manufacturers should submit the validation documents of the supporting system, equipment and facility, critical manufacturing processes (including cleaning validation) and analytical method of at least one product to the central health competent authority for inspection. The submission deadlines were 31 December 2000 for local manufacturers and 10 June 2002 for license holders of imported drugs. For those failing the submission or the assessment, the authority will make a public list of their company names and all their approved drug licenses in Taiwan, and give a deadline for improvement. These companies are not allowed to file any applications of new drug registration. Companies missing the deadline for improvement will be denied the rights to apply for license extension.(2)Manufacturers should submit the validation documents of the critical manufacturing processes (including cleaning validation) and analytical method of all products to the central health competent authority for inspection. The submission deadlines were 30 June 2002 for local manufacturers and 10 December 2003 for license holders of imported drugs. Companies failing the submission or the assessment will be handled according to the proceedings stated in item (1).(3)Manufacturers should fully implement all validation processes and submit the documents to the central health competent authority for inspection. The deadlines for submission are 30 June 2004 for local manufacturers and 10 December 2005 for license holders of imported drugs. Companies failing the submission or the assessment will be handled according to the proceedings stated in Item (1).(4)Validation would not be necessary for license holders that do not manufacture or import drugs to sell. This exemption took effect from 1 July 2002 for local drugs and from 11 December 2003 for imported drugs. However, licenses of imported drugs may be extended without validation, if the license holder submits the drug license and an assurance statement certifying that the drug will be imported for sale only after all validation documents have been submitted and approved. The license will be stamped, noting that the drug can not be imported due to deficiency of required documents. After all documents are submitted and approved, the license will be re-stamped, indicating that the drug can now be imported for sale on the grounds that full compliance has been met with the DOH’s requirements.(5)Penalties will be imposed on license holders pursuant to the Pharmaceutical Affairs Acts, if drugs have been produced or imported to sell without validation.
中文原文 藥品查驗登記審查準則第21條
藥品製劑確效作業之實施，規定如下：
一、申請查驗登記時，得先行檢齊申請藥品之分析方法確效作業報告書及關鍵性製程確效計畫書。
但核准後，應執行連續三批之製程確效，俟其結果符合規格後，始得上巿。
二、藥品確效作業應達到確保藥品之有效性及安全性，並符合中央衛生主管機關公告之藥品優良製造確效作業基準。
三、藥品確效作業之實施項目與時程規定如下：
（一）國產藥品製造廠應於民國八十九年十二月三十一日前，領有輸入藥品許可證之廠商應於民國九十一年六月十日前，檢附其藥品製造廠之支援系統、儀器、設備確效與該廠至少一種以上產品之關鍵性製程（含製程之清潔確效）及分析方法確效作業書面資料，送交中央衛生主管機關核備。
如未檢附資料或經審核不通過者，除依法公布該製造廠及其在我國境內之所有藥品許可證名單且令限期改善外，不准該廠藥品新案查驗登記。
如未於期限改善者，不准展延藥品許可證。
（二）國產藥品製造廠應於民國九十一年六月三十日前，領有輸入藥品許可證之廠商應於民國九十二年十二月十日前，完成各藥品關鍵性製程（含製程清潔確效）與分析方法確效作業之實施及送交中央衛生主管機關核備之程序。
如未檢附資料或經審核不通過者，準用前目規定處理。
（三）國產藥品製造廠應於民國九十三年六月三十日前，領有輸入藥品許可證之廠商應於民國九十四年十二月十日前，完成各藥品全面確效作業之實施及送交中央衛生主管機關核備之程序。
如未檢附資料或經審核不通過者，準用第一目規定處理。
（四）國產藥品自民國九十一年七月一日起，輸入藥品自民國九十二年十二月十一日起，持有許可證而不產製、不輸入販售者，得不執行確效作業。
但輸入藥品應檢附其藥品許可證，切結待備齊確效作業書面資料，經審核通過始得輸入該藥品販售，並於許可證正面加蓋本證未依本署公告事項規定檢齊資料不得輸入販售之章戳者，得不執行確效作業而准其許可證展延；其後如檢齊資料，經審核通過後，得於其許可證再加蓋本證業已依本署公告事項檢齊資料准予輸入販售之章戳。
（五）如有未執行確效作業而產製或輸入販售藥品者，依本法規定處罰。
一、申請查驗登記時，得先行檢齊申請藥品之分析方法確效作業報告書及關鍵性製程確效計畫書。
但核准後，應執行連續三批之製程確效，俟其結果符合規格後，始得上巿。
二、藥品確效作業應達到確保藥品之有效性及安全性，並符合中央衛生主管機關公告之藥品優良製造確效作業基準。
三、藥品確效作業之實施項目與時程規定如下：
（一）國產藥品製造廠應於民國八十九年十二月三十一日前，領有輸入藥品許可證之廠商應於民國九十一年六月十日前，檢附其藥品製造廠之支援系統、儀器、設備確效與該廠至少一種以上產品之關鍵性製程（含製程之清潔確效）及分析方法確效作業書面資料，送交中央衛生主管機關核備。
如未檢附資料或經審核不通過者，除依法公布該製造廠及其在我國境內之所有藥品許可證名單且令限期改善外，不准該廠藥品新案查驗登記。
如未於期限改善者，不准展延藥品許可證。
（二）國產藥品製造廠應於民國九十一年六月三十日前，領有輸入藥品許可證之廠商應於民國九十二年十二月十日前，完成各藥品關鍵性製程（含製程清潔確效）與分析方法確效作業之實施及送交中央衛生主管機關核備之程序。
如未檢附資料或經審核不通過者，準用前目規定處理。
（三）國產藥品製造廠應於民國九十三年六月三十日前，領有輸入藥品許可證之廠商應於民國九十四年十二月十日前，完成各藥品全面確效作業之實施及送交中央衛生主管機關核備之程序。
如未檢附資料或經審核不通過者，準用第一目規定處理。
（四）國產藥品自民國九十一年七月一日起，輸入藥品自民國九十二年十二月十一日起，持有許可證而不產製、不輸入販售者，得不執行確效作業。
但輸入藥品應檢附其藥品許可證，切結待備齊確效作業書面資料，經審核通過始得輸入該藥品販售，並於許可證正面加蓋本證未依本署公告事項規定檢齊資料不得輸入販售之章戳者，得不執行確效作業而准其許可證展延；其後如檢齊資料，經審核通過後，得於其許可證再加蓋本證業已依本署公告事項檢齊資料准予輸入販售之章戳。
（五）如有未執行確效作業而產製或輸入販售藥品者，依本法規定處罰。