The TFDA made this announcement according to Paragraph 2 of Article 40-1 of the Pharmaceutical Affairs Act, Paragraph 2 of Article 2 of the Regulation of the Publication of Drug Information , Article 6 and Article 18 of the Freedom of Government Information Law and the DOH’s announcement issued on July 7, 2006 (Ref. No.: 0950325965).
The aforementioned official announcement issued by the DOH (now the MOHW) regulates the matters concerning the uploading of clinical trial protocol summaries and other information to the “Taiwan Drug Clinical Trial Information Website”.
In order to expedite potential subjects’ access to the information of the clinical trials already approved by the TFDA, to protect the public’s welfare and to keep the information public and transparent, the TFDA announced that from February 1 2018, all clinical trial protocols should be publicized on the “Taiwan Drug Clinical Trial Information Website” (http://www1.cde.org.tw/ct_taiwan/archive1.html) after being approved by the TFDA.
The drug company should update the content available on the Information Website in a timely manner after changes of a clinical trial protocol have been approved by the authority. Drug companies should also regularly update the progress of clinical trials during the trial period so as to keep the information on the website accurate and complete.
【2018-01-23/ TFDA News Release】