医薬品・医療機器 GxP CSV要件に応える
コンサルティングサービス

NEWS

更新:FDA有害事象報告システム(FAERS)電子提出:コンテンツ現在:10/27/2021updated : FDA Adverse Event Reporting System (FAERS) Electronic Submissions: Content current: as of 10/27/2021

FDA ICH E2B(R2) Regulation
updated : FDA Adverse Event Reporting System (FAERS) Electronic Submissions: Content current: as of 10/27/2021

Dear Customer,   (first block in English and next block in Japanese)

I am sending the follow-up information for the FDA Adverse Event Reporting System (FAERS) Electronic Submissions:  Content current: as of 10/27/2021

https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions

  1. Updates for Electronic Submission of Individual Case Safety Reports (ICSRs) to FAERS:

Postmarketing Safety Reporting

FDA is modernizing the FDA Adverse Event Reporting System (FAERS).  The new system will go live on November 10, 2021.  For submissions made after November 10, the data elements Message Number (M.1.4) and Message Sender Identifier (M.1.5) must have distinct values for the submission to receive a positive acknowledgement from FAERS.  FDA expects there may be some delays in the generation of the second acknowledgement between November 10, 2021 and November 20, 2021.  Please continue to submit postmarketing safety reports using the current DTD 2.1 or DTD 2.2. 

For assistance contact the FAERS electronic submission coordinator at faersesub@fda.hhs.gov


2) I have asked the FDA to provide a supplementary explanation of the content of the above announcement. The results of the inquiry are shown below as a reference.

—————-( 2021/11/02(Tue) 0:17 from FDA FAERS Team)—————————————————————–

Hi,

Sponsors should continue to submit all Postmarket ICSRs to FAERS using E2B (R2) and DTD 2.1 or DTD 2.2.  It is up to the sender organization to determine what unique Message Number (M.1.4) and Message Sender Identifier (M.1.5) values to use when submitting a Postmarket ICSR.  The announcement posted on the FDA webpage for FAERS Postmarketing Electronic Submissions only clarifies that the combination of two mandatory ICSR tags must not have the same values while conforming to the ICH ICSR specifications for these XML tags – see below: 

Thanks,


2) Remarks:

  1. a) “The new system will go live on November 10, 2021” – > Is the FDA FARES-II: E2B (R3) version finally ready? I thought… But, “It was a misunderstanding.”
  2. b) As a precaution, I contacted FDA and they said that “Sponsors should continue to submit all Postmarket ICSRs to FAERS using E2B (R2) and DTD 2.1 or DTD 2.2“.
  3. c) Since the new FARES System will go live at 2021/11/10, the ICSR’s M.1.4/M.1.5 for subsequent individual adverse event cases

“The combination of two mandatory ICSR tags must not have the same values while conforming to the ICH ICSR specifications for these XML tags.”

  1. d) Also note that 2021/11/10 – > 2021/11/20 may delay ACK replies.
  2. e) For customers who have Postmarketing Safety Reporting directly connected to FDA via EDI GW from Japan, we recommend that you contact the FDA or your PV Safety System vendor in advance. For assistance contact the FAERS electronic submission coordinator at faersesub@fda.hhs.gov

お客さま 各位  (in Japanese)

いつもお世話になっております。 「HiroPharmaConsulting® Co., Ltd.」 集 弘就(あつまる ひろつぐ)です。

今回は、FDA Adverse Event Reporting System (FAERS) Electronic Submissions:  Content current: as of 10/27/2021発出についての続報と解説です(以下抜粋: 強調は当方による)。

https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions

  1. Updates for Electronic Submission of Individual Case Safety Reports (ICSRs) to FAERS:

Postmarketing Safety Reporting

FDA is modernizing the FDA Adverse Event Reporting System (FAERS).  The new system will go live on November 10, 2021.  For submissions made after November 10, the data elements Message Number (M.1.4) and Message Sender Identifier (M.1.5) must have distinct values for the submission to receive a positive acknowledgement from FAERS.  FDA expects there may be some delays in the generation of the second acknowledgement between November 10, 2021 and November 20, 2021.  Please continue to submit postmarketing safety reports using the current DTD 2.1 or DTD 2.2. 

For assistance contact the FAERS electronic submission coordinator at faersesub@fda.hhs.gov


  1. 上記発出内容の補足説明を FDAに求めました。その問い合せ結果のメール返信をご参考に以下に示します。

—————-( 2021/11/02 (火) 0:17 from FDA FAERS Teamより)—————————————————————–

Hi,

Sponsors should continue to submit all Postmarket ICSRs to FAERS using E2B (R2) and DTD 2.1 or DTD 2.2.  It is up to the sender organization to determine what unique Message Number (M.1.4) and Message Sender Identifier (M.1.5) values to use when submitting a Postmarket ICSR.  The announcement posted on the FDA webpage for FAERS Postmarketing Electronic Submissions only clarifies that the combination of two mandatory ICSR tags must not have the same values while conforming to the ICH ICSR specifications for these XML tags – see below: 

Thanks,


解説

  1. “The new system will go live on November 10, 2021” -> ついに、FDA FARES-II : E2B(R3)対応版が完成したか!と思ったのですが。。。。「勘違いでした。。」
  2. 念のためにFDAに問い合わせた結果は、”Sponsors should continue to submit all Postmarket ICSRs to FAERS using E2B (R2) and DTD 2.1 or DTD 2.2”とのことで、引き続き ICH E2B(R2)での報告が継続です。
  3. で、2021/11/10に new FARES Systemが Go-Liveするので、それ以降の個別有害事象症例の ICSRの M.1.4/ M.1.5は、

” the combination of two mandatory ICSR tags must not have the same values while conforming to the ICH ICSR specifications for these XML tags” とせよとのことです。

また、2021/11/10 -> 2021/11/20の期間は、ACKの返信が遅れることもあるので注意するようにとなっています。

なお、日本から FDAへPostmarketing Safety Reportingを直接 EDI GWで接続されているお客様は、事前に以下FDA窓口に問い合わせるか、お使いの PV Safety System提供ベンダー様にお問い合わせされることを推奨いたします。

For assistance contact the FAERS electronic submission coordinator at faersesub@fda.hhs.gov

それでは、引き続きよろしくお願いいたします。集

Hirotsugu Atsumaru (Hiro)

HiroPharmaConsulting® Co., Ltd.
Representative Director
Email: hiro_atsumaru@hiropharmaconsulting.com