歐盟缺藥通報及供應責任

基本上是基於2001/83/E指令
Aricle 23 a
obliges the marketing authorisation holder to notify the authority if a product ceases to be placed on the market even temporarily.
在斷藥前(即便是暫時性)都有責任要通知CA

另外在article 81提到
The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.
MAH以及藥品盤商有供應藥物的責任
但也並非哩哩砸砸阿里布達的藥都要執行，通常是該國家基礎必須用藥(essential medicine)，部分國家跟台灣一樣是採用WHO公告之必須用藥，在這範疇下就必須進該義務職責。
某些國家對於斷藥會有懲處，特別是有簽健保及供應合約的，這部分就需要去詳讀該國法規。

流感疫苗副作用

昨天早上接種完四價流感疫苗(Sanofi家的)後
晚上就出現類流感症狀
身體不適疲倦想睡
睡覺更慘
一直做很奇怪的夢
例如我回去台大醫院上班
還有遇到以前台大的同學(人已離職)
中間睡眠被打斷一次
第二段也是很詭異的夢
查了一下仿單也沒看到這種副作用
是大家都沒去注意還是只有我體質特殊
我是已經很久沒有作夢(或是其實醒來就忘記了)
不知道有人跟我一樣症狀嗎?

臍帶血，該不該存

提到臍帶血就想起我高中時代

剛好是桃莉羊誕生沒幾年

台大剛把三個系合併成生命科學系

幹細胞研究啥的都熱到翻

想知道有多熱可以參考黃禹錫事件

https://zh.wikipedia.org/wiki/%E9%BB%83%E7%A6%B9%E9%8C%AB

當初研究幹細胞應用的韓國首席科學家

多次上CNN的報導

結果證實都是一堆造假

還有後來STAP細胞造假事件

https://zh.wikipedia.org/wiki/%E5%B0%8F%E4%BF%9D%E6%96%B9%E6%99%B4%E5%AD%90

拉回主題

臍帶血該不該存

參考維基百科的說明

捐臍帶血[編輯]

國外，一般公捐臍帶血的較常見，且獲得政府單位支持，臺灣反倒是出現9家私人臍帶血業者^[5]，誠屬特例。^[2]

香港醫學會前會長謝鴻興表明，不會主動建議家長儲存子女臍帶血。^[6]

迷思[編輯]

以台灣公告臍帶血適應症為例，2014年僅29項，且多為血液、骨髓相關疾病，並無治百病的謬論。異體移植，歐美國家研究，以血癌、先天性貧血等疾病的受贈者居多，尚朝治療罕病、中風和脊髓損傷等發展，實際醫療應用有待努力。^[2][9][6]

可以看到實際應用有限

這東西目前廣告宣稱大概跟我高中時代沒差多少

都是在宣揚一個夢想一個機會

15年過去了

是現實還是夢想

不用說應該也很明顯了吧

另外補充歐洲其實是禁止臍帶血商業化
原因在於很多臍帶血其實不是用來救自己而是救別人

可以參考這篇文章https://www.thenewslens.com/article/240

台灣礙於擋人財路所以不好說

有興趣可以自行搜尋相關文獻報導會更清楚

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drug patent challenge process

什麼情況下不需要申請醫療器材之仿單、標籤、外包裝的變更? 【發布日期：2013-05-07】

依據行政院衛生署89年2月2日衛署藥字第89006412號公告: 醫療器材之標籤、仿單或外盒變更，無需申請核准之項目（如附件(另開視窗)），自即日起凡符合本公告事項規定者，廠商得配合市場上需要，自行調整，不須向本部申請變更登記。

What should specification developer do according to FDA?

1.      Follow part 820

Sec. 820.5 Quality system.

Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.5

Sec. 820.3 Definitions. (o)Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.3

2.      submit 510K

Who is Required to Submit a 510(k)

The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission.

The following four categories of parties must submit a 510(k) to the FDA:

Specification developers introducing a device to the U.S. market;

A specification developer develops the specifications for a finished device, but has the device manufactured under contract by another firm or entity. The specification developer submits the 510(k), not the contract manufacturer.

https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm#who

3.      Registration and listing (part 807)

Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.

https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/registrationandlisting/ucm053165.htm

4.      Follow the MDR and report (part 803)

(l) Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who either:

(1) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture;

(2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications;

(3) Manufactures components or accessories that are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or

(4) Is the U.S. agent of a foreign manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=803.3

5.      Correction and removal (part 806)

Same scope with part 803

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=806&showFR=1&subpartNode=21:8.0.1.1.4.2

Toyota Altis 九代 保養手冊 規格與週期