FDA關(guān)于藥品有效期的問答---可能是您關(guān)心的

時間：2024-03-14作者：上海角宿企業(yè)管理咨詢有限公司瀏覽：27

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)定的時間，這意味著它在根據(jù)其標(biāo)簽的儲存條件儲存時可以保持其強(qiáng)度、質(zhì)量和純度。

2.如何確定有效期？

FDA法規(guī)要求藥品申請人在提交FDA批準(zhǔn)其藥品的申請時提供穩(wěn)定性測試數(shù)據(jù)，包括建議的有效期和儲存條件。該測試旨在為產(chǎn)品在整個有效期內(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)申請人提出的有效期是否得到申請人所進(jìn)行的適當(dāng)研究的支持。

對于非應(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)定性測試，以確定有效期和儲存條件，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建議申請人和生產(chǎn)商遵循**統(tǒng)一的穩(wěn)定性測試指導(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對生產(chǎn)設(shè)施的檢查可能包括對公司穩(wěn)定性測試程序的評估，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)自己的測試和可接受的數(shù)據(jù)，根據(jù)新藥申請(NDA)或簡化新藥申請(ANDA)中批準(zhǔn)的協(xié)議延長藥品的有效期(見21 CFR 314.70)。為了幫助緩解藥品短缺，當(dāng)有數(shù)據(jù)支持延長有效期時，FDA也批準(zhǔn)延長有效期。

4.過期藥品有哪些潛在風(fēng)險？

重要的是要意識到，服用過期藥品或由于沒有按照標(biāo)簽條件儲存而可能降解的藥品，可能會產(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，因為它的強(qiáng)度**預(yù)期。此外，當(dāng)藥品降解時，可能會產(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*受到未妥善儲存藥品的潛在風(fēng)險的影響?；颊呖梢圆扇∫恍┖唵蔚牟襟E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)行測試以延長有效期？

FDA支持與其他合作伙伴一起的公共衛(wèi)生項目，以延長精心挑選的有限數(shù)量藥品的有效期。根據(jù)有效期延長計劃(SLEP)， FDA對儲存在環(huán)境受控的聯(lián)邦儲備庫中的某些藥品進(jìn)行測試(聯(lián)邦儲備庫存儲了預(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是一項收費服務(wù)計劃，通過該計劃，在選定的藥品經(jīng)過FDA進(jìn)行的定期穩(wěn)定性測試后，某些聯(lián)邦儲備藥品的標(biāo)簽有效期可以延長。

患者持有的藥品在進(jìn)入市場后可能已經(jīng)在不同的條件下儲存。因此，很難進(jìn)行測試，以確定在不同條件下長期儲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,歐代注冊,歐洲自由銷售證明,MDR認(rèn)證,ISO13485認(rèn)證,SFDA注冊,FDA注冊等, 歡迎致電 17802157742

• 詞條

  詞條說明

• 省錢途徑——申請加拿大小微企業(yè)的要求及流程

  加拿大醫(yī)療器械管理局（Health Canada）為小微企業(yè)提供了特殊的申請流程和費用減免政策。以下是申請小微企業(yè)身份的要求和詳細(xì)流程：1. 申請條件為了符合小微企業(yè)的定義，企業(yè)必須滿足以下條件之一：- 員工人數(shù)少于100人；或- 年收入在30,000加元至5,000,000加元之間。2. 減免費用從2020年4月1日起，符合條件的小微企業(yè)可以享受以下費用減免：- **提交前市場評估申請/通知免費

• 如何查詢美國FDA的相關(guān)注冊碼？

  在美國，F(xiàn)DA的相關(guān)注冊碼包括FDA510K注冊碼、Owner/Operator Number(身份識別碼)和Registration Number(企業(yè)注冊碼)。根據(jù)美國FDA的相關(guān)法規(guī)，這三種注冊碼是可以公共查詢的，普通民眾可以在系統(tǒng)網(wǎng)頁上進(jìn)行查詢。下面將詳細(xì)介紹如何查詢這些注冊碼。1. 查詢Owner/Operator Number和Registration Number：?&nb

• OTC在FDA的上市要求是什么？

  OTC的上市要求符合安全和有效的標(biāo)準(zhǔn)；良好的生產(chǎn)規(guī)范cGMP；按照法規(guī)要求貼標(biāo)。1. CGMPCGMP即良好的生產(chǎn)規(guī)范，F(xiàn)DA通過監(jiān)控Drug制造商的CGMP來確保Drug的質(zhì)量。Drug CGMP?法規(guī)包含對Drug生產(chǎn)、加工和包裝中使用的方法、設(shè)施和控制的*低要求。法規(guī)確保產(chǎn)品使用安全，并具有其聲稱的成分和強(qiáng)度。2.?標(biāo)簽定義：任何物品或其任何容器或包裝上的所有標(biāo)簽和其他書

• 美國FDA對二類醫(yī)療器械注冊要求

  美國FDA對二類醫(yī)療器械的注冊要求是比較嚴(yán)格的，申請人需要提供充分的數(shù)據(jù)和證據(jù)，證明產(chǎn)品的安全性和有效性。以下是針對二類醫(yī)療器械注冊的一些建議，希望能幫助您較好地了解和應(yīng)對這些要求。?1. 申請流程在提交510(k)申請文件之前，申請人需要對已上市的類似產(chǎn)品進(jìn)行詳細(xì)的市場調(diào)研，了解市場上同類產(chǎn)品的性能、特點、優(yōu)缺點等信息。在申請過程中，需要提供詳細(xì)的產(chǎn)品說明、產(chǎn)品設(shè)計圖紙、性能比較數(shù)據(jù)、