FDA關(guān)于藥品有效期的問答---可能是您關(guān)心的

時(shí)間：2024-03-14作者：上海角宿企業(yè)管理咨詢有限公司瀏覽：29

1. Why are expiration dates important for consumers to pay attention to?

Drug expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions.

2. How are expiration dates established?

FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for FDA approval of their drug.  This testing is designed to provide confidence that the product will meet the applicable standards of strength, quality, and purity throughout its shelf-life. The FDA verifies that an applicant’s proposed expiration date is supported by appropriate studies that the applicant has conducted.

For non-application drugs, such as over-the-counter monograph products, the manufacturer must also conduct stability testing to establish an expiration date and storage conditions to meet FDA’s regulations (see 21 CFR 211.166 as well as related sections 211.137 and 211.160) . 

FDA recommends that applicants and manufacturers follow the recommendations in internationally harmonized guidance documents on stability testing such as the International Council on Harmonization guidance documents (ICH) Q1(A-F) and Q5C.

FDA inspections of manufacturing facilities may include an evaluation of the firm’s stability testing program to verify that labeled expiration dates are supported by a scientifically sound study and appropriate data.

3. Can expiration dates be extended?

FDA’s guidance for industry, “Changes to an Approved NDA or ANDA” explains that the manufacturer of an approved drug product may extend the expiration date for the drug product based on their own testing and acceptable data in accordance with a protocol approved in the new drug application (NDA) or abbreviated new drug application (ANDA) (see 21 CFR 314.70).  To help alleviate drug shortages, FDA has also approved extensions of expiration dates when data supporting the extension are available.

4. What potential risks are associated with expired drugs?

It’s important to be aware that there are several potential harms that may occur from taking an expired medicine or one that may have degraded because it was not stored according to the labeled conditions. If a drug has degraded, it might not provide the patient with the intended benefit because it has a lower strength than intended. In addition, when a drug degrades it may yield toxic compounds that could cause consumers to experience unintended side effects. Patients with serious and life-threatening diseases may be particularly vulnerable to potential risks from drugs that have not been stored properly.  There are a number of simple steps consumers can take to dispose of expired medications.

5.  Does FDA conduct testing to extend expiration dates?

FDA supports a public health program involving other partners to extend the expiration dates for a limited number of carefully selected drug products. Under the Shelf-Life Extension Program (SLEP), FDA conducts testing for certain products stored in federal stockpiles in environmentally controlled locations.  (Federal stockpiles are stores of certain drugs that might be needed to prevent or treat diseases or conditions which may occur during a public health emergency.)  SLEP is a fee-for-service program through which the labeled shelf life of certain federally stockpiled products can be extended after select products undergo periodic stability testing conducted by FDA.

Drugs held by consumers may have been stored under varied conditions after entering the market.  As a result, it would be difficult to conduct testing to determine expiration dates that would be meaningful and generally applicable after prolonged periods of storage under different conditions. The appropriate conditions will depend on the drug, but may include considerations regarding temperature, humidity, and exposure to light.

1.為什么有效期期對(duì)患者來說很重要?

藥品有效期反映了已知產(chǎn)品保持穩(wěn)定的時(shí)間，這意味著它在根據(jù)其標(biāo)簽的儲(chǔ)存條件儲(chǔ)存時(shí)可以保持其強(qiáng)度、質(zhì)量和純度。

2.如何確定有效期？

FDA法規(guī)要求藥品申請(qǐng)人在提交FDA批準(zhǔn)其藥品的申請(qǐng)時(shí)提供穩(wěn)定性測(cè)試數(shù)據(jù)，包括建議的有效期和儲(chǔ)存條件。該測(cè)試旨在為產(chǎn)品在整個(gè)有效期內(nèi)滿足強(qiáng)度、質(zhì)量和純度的適用標(biāo)準(zhǔn)提供信心。FDA確認(rèn)申請(qǐng)人提出的有效期是否得到申請(qǐng)人所進(jìn)行的適當(dāng)研究的支持。

對(duì)于非應(yīng)用藥品，例如非處方各論產(chǎn)品，生產(chǎn)商也必須進(jìn)行穩(wěn)定性測(cè)試，以確定有效期和儲(chǔ)存條件，以滿足FDA的規(guī)定(見21 CFR 211.166以及相關(guān)章節(jié)211.137和211.160)。

FDA建議申請(qǐng)人和生產(chǎn)商遵循**統(tǒng)一的穩(wěn)定性測(cè)試指導(dǎo)文件中的建議，例如**協(xié)調(diào)指導(dǎo)文件(ICH) Q1(A-F)和Q5C。

FDA對(duì)生產(chǎn)設(shè)施的檢查可能包括對(duì)公司穩(wěn)定性測(cè)試程序的評(píng)估，以確認(rèn)所標(biāo)注的有效期是由科學(xué)合理的研究和適當(dāng)?shù)臄?shù)據(jù)支持的。

3.有效期可以延長(zhǎng)嗎？

FDA的行業(yè)指南“已批準(zhǔn)NDA或ANDA的變更”有解釋，已批準(zhǔn)藥品的生產(chǎn)商可以根據(jù)自己的測(cè)試和可接受的數(shù)據(jù)，根據(jù)新藥申請(qǐng)(NDA)或簡(jiǎn)化新藥申請(qǐng)(ANDA)中批準(zhǔn)的協(xié)議延長(zhǎng)藥品的有效期(見21 CFR 314.70)。為了幫助緩解藥品短缺，當(dāng)有數(shù)據(jù)支持延長(zhǎng)有效期時(shí)，FDA也批準(zhǔn)延長(zhǎng)有效期。

4.過期藥品有哪些潛在風(fēng)險(xiǎn)？

重要的是要意識(shí)到，服用過期藥品或由于沒有按照標(biāo)簽條件儲(chǔ)存而可能降解的藥品，可能會(huì)產(chǎn)生幾種潛在的危害。如果藥品已經(jīng)降解，它可能無法為患者提供預(yù)期的益處，因?yàn)樗膹?qiáng)度**預(yù)期。此外，當(dāng)藥品降解時(shí)，可能會(huì)產(chǎn)生有毒化合物，導(dǎo)致患者產(chǎn)生意想不到的副作用?；加袊?yán)重和危及生命疾病的患者可能特別*受到未妥善儲(chǔ)存藥品的潛在風(fēng)險(xiǎn)的影響?；颊呖梢圆扇∫恍┖?jiǎn)單的步驟來處理過期的藥品。（官網(wǎng)附著這些具體的simple steps ）

5.FDA是否進(jìn)行測(cè)試以延長(zhǎng)有效期？

FDA支持與其他合作伙伴一起的公共衛(wèi)生項(xiàng)目，以延長(zhǎng)精心挑選的有限數(shù)量藥品的有效期。根據(jù)有效期延長(zhǎng)計(jì)劃(SLEP)， FDA對(duì)儲(chǔ)存在環(huán)境受控的聯(lián)邦儲(chǔ)備庫(kù)中的某些藥品進(jìn)行測(cè)試(聯(lián)邦儲(chǔ)備庫(kù)存儲(chǔ)了預(yù)防或**突發(fā)公共衛(wèi)生事件期間可能發(fā)生的疾病或狀況所需的某些藥品)。SLEP是一項(xiàng)收費(fèi)服務(wù)計(jì)劃，通過該計(jì)劃，在選定的藥品經(jīng)過FDA進(jìn)行的定期穩(wěn)定性測(cè)試后，某些聯(lián)邦儲(chǔ)備藥品的標(biāo)簽有效期可以延長(zhǎng)。

患者持有的藥品在進(jìn)入市場(chǎng)后可能已經(jīng)在不同的條件下儲(chǔ)存。因此，很難進(jìn)行測(cè)試，以確定在不同條件下長(zhǎng)期儲(chǔ)存后有意義且普遍適用的有效期。適當(dāng)?shù)臈l件將取決于藥品，但可能包括考慮溫度、濕度和光暴露。








上海角宿企業(yè)管理咨詢有限公司專注于FDA510(K),N95認(rèn)證,TGA注冊(cè),歐代注冊(cè),歐洲自由銷售證明,MDR認(rèn)證,ISO13485認(rèn)證,SFDA注冊(cè),FDA注冊(cè)等, 歡迎致電 17802157742

• 詞條

  詞條說明

• FDA 510K實(shí)質(zhì)等同的意義和要求，對(duì)醫(yī)療器械產(chǎn)品開展注冊(cè)的作用

  FDA 510K實(shí)質(zhì)等同是新醫(yī)療設(shè)備在上市前需要通過的一項(xiàng)重要審查標(biāo)準(zhǔn)。該標(biāo)準(zhǔn)要求新設(shè)備必須與合上市的設(shè)備（謂詞設(shè)備）在安全性和有效性方面具有相同的表現(xiàn)，從而減少監(jiān)管流程并提高場(chǎng)準(zhǔn)入速度。一、實(shí)質(zhì)等同的定義FDA在510(k)提交的上下文中將“實(shí)質(zhì)上等效”定義為至與合法上市的設(shè)備（謂詞設(shè)備）一樣安全和有效的新醫(yī)療設(shè)備。實(shí)質(zhì)等同的概念允許新設(shè)備依賴類似現(xiàn)有設(shè)備的安全性和有效性數(shù)據(jù)，而*進(jìn)行多余的臨

• 歐盟授權(quán)代表是必須的嗎？授權(quán)代表能履行哪些職責(zé)？

  醫(yī)療器械的歐盟授權(quán)代表職責(zé)是確保醫(yī)療器械制造商在歐盟市場(chǎng)上合規(guī)運(yùn)營(yíng)的重要一環(huán)。根據(jù)歐盟相關(guān)法規(guī)，如果醫(yī)療器械制造商未在成員國(guó)內(nèi)成立，必須指定唯一的授權(quán)代表才能將設(shè)備投放到歐盟市場(chǎng)。授權(quán)代表的名稱必須構(gòu)成授權(quán)，并且在書面接受后才能生效，并且對(duì)同一通用設(shè)備組的所有設(shè)備都有效。授權(quán)代表的主要任務(wù)是執(zhí)行與制造商之間約定的任務(wù)。這些任務(wù)包括驗(yàn)證是否已制定歐盟符合性標(biāo)準(zhǔn)和技術(shù)文件，并確保制造商執(zhí)行了適當(dāng)?shù)暮细?/p>

• 加拿大對(duì)進(jìn)口醫(yī)療器械的質(zhì)量和安全采取哪些行動(dòng)？

  加拿大衛(wèi)生部對(duì)銷售、分銷和進(jìn)口設(shè)備的公司進(jìn)行檢查，還檢查 I 類設(shè)備的制造商。加拿大衛(wèi)生部定期檢查許可證持有人，以確保他們遵守《食品藥品法》和《醫(yī)療器械條例》。在不合規(guī)的情況下，我們將根據(jù)所構(gòu)成的風(fēng)險(xiǎn)水平采取行動(dòng)。所采取的合規(guī)和執(zhí)法行動(dòng)取決于對(duì)加拿大人健康構(gòu)成的風(fēng)險(xiǎn)。采取的行動(dòng)有：l?召回醫(yī)療設(shè)備l?沒收未經(jīng)許可的設(shè)備l?請(qǐng)求更改標(biāo)簽l?發(fā)出停售信l&nbs

• 醫(yī)療器械沙特SFDA注冊(cè)申請(qǐng)時(shí)技術(shù)文件要求

  醫(yī)療器械沙特SFDA注冊(cè)需要提交詳細(xì)的技術(shù)文件。這些文件應(yīng)該以清晰、有組織、易于搜索和明確的方式呈現(xiàn)。在本文中，我們將介紹SFDA醫(yī)療器械注冊(cè)時(shí)技術(shù)文件的要求清單，以幫助您較好地準(zhǔn)備技術(shù)文件。1. 設(shè)備描述和標(biāo)準(zhǔn)，包括變體和配件在技術(shù)文件中，應(yīng)包括對(duì)設(shè)備的詳細(xì)描述，包括設(shè)備的型號(hào)、規(guī)格、特征和功能。此外，還應(yīng)包括設(shè)備的標(biāo)準(zhǔn)、規(guī)范和指南，以確保設(shè)備符合相關(guān)法規(guī)和標(biāo)準(zhǔn)。如果設(shè)備有變體或配件，也應(yīng)包括在