Alex's Biolaw & Regulation Plaza

Dec 21 Wed 2011 02:39
TFDA ANNOUNCED THE CRITERIA FOR CLINICAL TRIAL TO STRENGTHEN DOMESTIC SOMATIC CELL-BASED THERAPEUTIC PRODUCT

TFDA ANNOUNCED THE CRITERIA FOR CLINICAL TRIAL TO STRENGTHEN DOMESTIC SOMATIC CELL-BASED THERAPEUTIC PRODUCT

To ensure the clinical trial of somatic cell therapy complying with the scientific standard, safety, and social ethics, as well as to protect the participants’ right, the Taiwan Food and Drug Administration, Department of Health (hereinafter TFDA) officially announced draft version of “the Criteria for Clinical Trial of Somatic Cell Therapy” (hereinafter the Draft), several months ago this year. In addition to regulating the stem cell-based treatments, the Draft also requested all related project leaders to follow the rules while preparing documents for the application of clinical trial…

written by Shihchang, Sun

For more information, please refer to this website: http://stli.iii.org.tw/e-epaper/2011/ep03.html

This work is licensed under a Creative Commons Attribution-ShareAlike 3.0 Taiwan License.

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個人分類：2011 Sep.

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Dec 21 Wed 2011 02:36
TAIWAN AND CHINA SIGNED THE MEDICAL HEALTH COOPERATION AGREEMENT

TAIWAN AND CHINA SIGNED THE MEDICAL HEALTH COOPERATION AGREEMENT

To promote the cross-strait relationship to step forward and achieve the goal, which co-development by economic reciprocal cooperation ways, Taiwan and China held the 6th Chiang-Chen talks, and signed the cross-strait agreement on medical health cooperation on December 12, 2010. Before signing the agreement, the Department of Health (hereinafter "DOH") indicated that the scope of the cross-strait cooperation was to focus on four important issues, including: (1) medicine safety management and it´s R&D; (2) infectious disease prevention; (3) traditional Chinese medicine safety management and research; and (4) emergency medical care. In addition, Taiwan will use the international standards set forth by the US Food and Drug Administration drug approval criteria as basis for the negotiation in establishing the cross-strait drug approval system. Meanwhile, an infectious disease notification system will also be set up to strengthen the quality management of traditional Chinese medicine on both sides, and to build up the cross-strait emergency medical care and assistance mechanism…

written by Shihchang, Sun

For more information, please refer to this website: http://stli.iii.org.tw/e-epaper/2011/ep01.html

This work is licensed under a Creative Commons Attribution-ShareAlike 3.0 Taiwan License.

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個人分類：2011 Mar.

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為確保政府所投入之龐大資金能確實發揮預期成效、導引該國生技醫藥產業朝既定產業政策方向發展、與促進具重要性之生技醫藥研發計畫不致受到非預期性阻礙，美、歐等先進國家於近年間，已相繼公布新政策及相關規定來架構其防免與管理之原則及措施，來解決醫藥品查驗機構專家諮詢委員利益衝突問題…

科技法律透析期刊 2011/09 (文/孫世昌)

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個人分類：生技醫藥領域之利益衝突問題

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Oct 28 Fri 2011 11:42
2011/09/02中山醫學大學附設醫院~人體臨床試驗「倫理、科學、法規與GCP (六)」

主辦單位：中山醫學大學附設醫院臨床試驗中心
中山醫學大學附設醫院人體試驗委員會
中山醫學大學附設醫院醫學研究部

協辦單位：中山醫學大學醫學研究所

中山醫學大學附設醫院中藥臨床試驗中心

活動日期：100年9月2日（星期五）下午13:20-17:20

活動地點：中山醫學大學附設醫院大慶院區行政大樓12樓慶壽國際會議廳

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個人分類：生技法律

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Aug 01 Mon 2011 18:18
為保障大眾健康 FDA將阻撓IVDMIAs發展？

生技與醫療器材報導2011/08/01(文／孫世昌)

今（2011）年初，美國食品藥物管理局（FDA）「醫療器材與體外診斷醫療器材評估與安全辦公室」（Office of In Vitro Diagnostic Device Evaluation and Safety；簡稱OIVD）官員Joshua Levin，針對業者所提出的兩項IVDMIAs上市申請案提出重要看法。兩項IVDMIAs上市申請案一為蛋白質定量多樣化免疫親和性質譜分析平台（稱為PepCa10），另一為醣蛋白異構物定量分析免疫晶片陣列平台（稱為SDIA）他表示，依美國FDA再細緻化後的體外診斷多重指標分析醫材管理政策，現階段對IVDMIAs醫材的上市管理，著重於此類醫材其分析結果的「再現性」（Reproducibility）檢驗、及在臨床試驗時所選取的病患群體是否合適。

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個人分類：醫療器材

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Oct 22 Wed 2014 01:44
Collagen type 21 alpha 1 gene polymorphism in patients with cardiovascular diseases

ITRI Biotechnology Forum, 2003

Shih-chang Sun, Shuenn-Nan Chiu, Mei-Hwan Wu and Min-Yuan Chou

Department of Applied Gene Technology (H300), Biomedical Engineering Center,

Department of Pediatrics, National Twain University Hospital

ABSTRACT

The human a1-chain of type XXI collagen (COL21A1) is an extracellular matrix component of the blood vessel walls. Our previous study showed that the expression of COL21A1 in human tissues is developmentally regulated, suggesting that the collagen type 21 may contribute to the extracellular matrix assembly of the vascular network during blood vessel formation. It is attractive to speculate that the COL21A1 gene mutation may cause dysfunction in blood vessel assembly during arteriogenesis.

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Oct 26 Sat 2013 16:08
打擊生物瓢竊~歐盟議會支持新規則草案

醫藥新聞週刊 2013/10 (文/孫世昌)

據歐盟政府於日前所發布之一項消息指出，歐盟議會(European Parliament) 已正式表決通過，支持一項關於當境內企業對他國傳統知識進行商業化利用時(例如以當地所特有之植物為基礎來開發產製某種新藥品並進行上市銷售)，將要求業者，須向當地民眾(Indigenous People)做出合理補償所提出之「生物瓢竊法」(Biopiracy Law)草案；而有關此項新規則草案之目的，主要係為進一步落實歐盟稍早所簽訂「古屋議定書」(Nagoya Protocol)中之相關要求

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個人分類：提升藥品管理之相關措施

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Oct 26 Sat 2013 15:58
EMA公布新修正版生物相似性藥品指引文件

醫藥新聞周刊 2013/10 (文/孫世昌)

為促進其境內生物相似性藥品之開發與產業發展，歐洲藥品管理局(European Medicines Agency；簡稱EMA)於今(2013)年6月中旬，提出了一項新修正版之「含有以生物技術衍生蛋白質為主要活性成分之生物相似性藥品之臨床/非臨床管理上要求指引文件」(Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: nonclinical and clinical issues)，並向大眾徵詢相關意見

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個人分類：Biosimilar

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Dec 30 Fri 2011 15:23
FDA日前對境內營養補充品製造商採取正式法律行動

醫藥新聞周刊 2011/12 (文/孫世昌)

為強化美國境內對營養補充性產品品質與安全管理，聯邦食品藥物管理局(Food and Drug Administration；簡稱FDA)於今(2011)年11月23日，正式向美國Pennsylvania西區地方法院，對未確實遵守「營養補充品現行優良製造標準」(current Good Manufacturing Practice；簡稱cGMP)相關規定之營養補充品製造/販售商(包括Manufacturing ATF Dedicated Excellence Inc.、ATF Fitness Products Inc.公司)及其經營者James G. Vercellotti提起訴訟，並由美國司法部(U.S. Department of Justice)發布一項禁制令，禁止其製造及販售其下可能違反「美國聯邦食品藥物化妝品管理法」(Federal Food Drug and Cosmetic Act；簡稱FFDCA法)相關規定之400多項(包括Sci-Fit、Nature’s Science等品牌)營養補充性產品。

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個人分類：TM/CAM

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Dec 25 Sun 2011 00:02
授權學名藥策略對藥品市場影響~FTC報告書(2011)

法源法律網 (文/孫世昌)

於今（2011）年8月底，美國聯邦貿易委員會（Federal Trade Commission；簡稱FTC）針對境內品牌藥商於市場導入該公司之授權學名藥產品（Authorized Generic）策略，其長短期影響評估，公布了一份「授權學名藥：短期影響及長期衝擊報告書」（Authorized Generic Drugs：Short-Term Effects and Long-Term Impact Report），而根據此份新出爐之評估報告內容，美國政府對藥廠近年所採AG策略之影響，有幾項重要發現：其一，品牌藥廠所採之AG商業策略，將對競爭學名藥廠商之市場利潤產生必然且實質之影響；其二，FTC專家已發現一些可支持「因AG之存在將影響競爭學名藥品廠商以訴訟方式挑戰原品牌藥品專利決定」之證據；其三，根據FTC所蒐集之證據顯示，某些品牌藥品廠商，正轉而利用AG策略，透過實質影響競爭學名藥品廠商商業利益之方式，來作為迫使競爭學名藥廠同意延遲其所開發新學名藥品上市時點之另一種手段（此為FTC此份報告最重要之發現）。