MHLW Line Listing Reports

Periodic safety report facilitates the pharmaceutical companies to periodically submit the Line Listing Report to Ministry of Health, Labor, and Welfare (MHLW) regarding the results of efficacy and safety surveys on new ethical drugs. In addition to this occurrence of Adverse Events are also reported at the early stage of marketing, by collecting the information on the proper use of the products.

New regulations to periodically report Unlabeled/non-serious ADR cases came into effect in April 1, 2005. It is required by MHLW to submit this report every 6 months for the first two years after the approval and then annually after 2 years.

Set of validation is applied for the data printed in CSV files (CSV1, CSV2 and CSV3 files). The validation check is handled in the selection criteria of Unlabeled/Non-serious Report Layout sub-tab. When you enter invalid characters in these fields the report generation cannot be continued.

The Ornamental Kanji characters are validated and are not allowed in the J type field.

Marketing authorization holders (MAH) in Japan is required to investigate the efficacy and adverse reaction of new drugs during reexamination period and apply for reexamination of the drugs within 3 months after the reexamination period.

The duration of reexamination period depends on type of drugs 6 years from the approval date for new drugs, 4 years for additional efficacy, and 10 years for orphan drugs.

This report is the attachments of re-examination application and it is the index of study report. The same is reported to Pharmaceuticals and Medical Device Agency (PMDA). Each study report is published in an academic journal.

Select Reports > MHLW Line Listing Reports from menu bar to invoke the MHLW Line Listing Reports Selection page.

Parameters

Report Parameters are provided to control printing of certain information on reports. The types of parameters that are available are:

Runtime Parameters

The section below describes the runtime parameters for the MHLW Line Listing Periodic Report.

The selection criteria MHLW Periodic Report tab consists of two sub-tabs, Search criteria sub-tab and Layout sub-tab (レイアウト).

Header/No		Parameter	Values	Description
Query Name 検索条件名		Query Name	Text box (Read-only mode)	Displays the name of the created selection criteria. Click Save button, to edit the name.
行政報告画面の被疑薬との同期		Consider IA Product Synchronization with suspect drug in informed authority screen	Checkbox	Select this checkbox to consider Informed Authority Product, to be printed on the Format 3 and 4 reports.
Select product by one of the following 下記の製品条件の１つを入力してください。	1	Product Description (CPD look up)	Local trade name ローカル製品名	You can enter the local trade name for selecting and printing the report here. The CPD look up button will be provided along with this field so that you can select the trade name from the look up. Common Navigation button is provided to enter multiple trade names. Enter either trade name or Japanese drug codes only.
	2	Japanese Drug code(Japanese Drug Dictionary look up)	Japanese drug code 日本薬剤コード	You can enter the Japanese drug code for selecting and printing the report here. The Japanese Drug look up button will be provided along with this field so that you can select the Japanese drug code from the look up. Common Navigation button is provided so that you can enter multiple Japanese drug code. Enter either trade name or Japanese drug codes only. The local trade names or Japanese drug codes are mandatory selection criteria for the generation of report.
Date range 調査単位期間	3	Survey period(with navigation button and CPD look up for only one selection )	From	From date of the survey
			To ＿＿　～＿＿＿	To date of the survey You can select the survey period from local trade name field, click on the lookup button. Multiple survey periods are entered using the navigation button. Future date is accepted in the survey period “To date” field of the MHLW LL selection criteria, and the report is generated accordingly. This is applied to the selection criteria of Periodic Report Format 3, Periodic Report Format 4. If the survey period is selected from CPD, the date is displayed as it is into the survey period. Future date is not modified to the current date in the “To date” field. Survey Period is mandatory selection criteria to generate MHLW Periodic Report.
Indication 投与目的	4	Indication term(provide MedDRA look up here with navigation buttons)	PT PTコード	Enter Indication term in the following fields: Both the fields are entered to get the cases inclusive of both values. You can select both PT and HLGT by using lookup buttons. Multiple Indication terms are entered using the navigation button. The indication entered corresponds to all the entered Local trade name or Japanese drug code. When PT is selected, there could be more than one HLGT associated in MedDRA dictionary. You can select particular PT/HLGT combination and the combination is displayed into the PT/HLGT field. HLGT lookup also displays the combination of HLGT and PT same as PT lookup. If both local trade name and indication are entered in the selection criteria, only those cases are included in the reports that have both the local trade name and indication values specified in search criteria.
			HLGT HLGTコード
Study 承認迄の状況	5	Study information (Protocol look up with navigation button is provided here)	Project number プロジェクト番号	Enter Study Information of the drug for selecting the case in following fields: Both the fields are entered to get the cases inclusive of both values Lookup button and navigation button (common for both Project number and Protocol number) are provided for each field, to select one or more values of the study information Study information is applicable only for study cases
			Protocol number プロトコル番号
	6	Total number of study survey 調査症例数	Text edit to enter the number	Entered value calculates the frequency of the study ADRs.
Report type 帳票の種類	7	Report type	Combo box to select the report type 安全性定期報告/再審査申請	In the field combo box is provided to the field items mentioned. Select any one of the field items to get the title of the report printed accordingly. Post marketing survey reports field is the default value.
			Periodic safety report Form 3/ Re-examination application Form 10	Generate the Periodic safety report Form 3/Reexamination application Format 10: Select the option to generate the report.
			Periodic safety report Form 4/ Re-examination application Form 11	Generate the Periodic safety report Form 4/Re-examination examination application Form 11: Select the option to generate the report.
			Periodic safety report Form 3 (old) /Re-examination application Form 4 (old) 安全性定期報告　別紙様式3/再審査申請　別紙様式4	Generate the Periodic safety report Form 3 (old) /Re-examination application Form 4 (old): Select the option to generate the report.
			Periodic safety report Form 4 (old) /Re-examination application Form 5 (old) 安全性定期報告　別紙様式4/再審査申請　別紙様式5	Generate the Periodic safety report Form 4 (old) /Re-examination appliaction Form 5(old): Select the option to generate the report.
Domestic/Foreign cases 集積対象症例	8	Domestic/Foreign cases	Domestic cases (radio button) 国内	If report type contains “国内”, it will be considered as Domestic case. If report type contains “外国”, it will be considered as Foreign case. The report type field in the Informed Authority screen will be used for identifying whether a case is domestic or foreign. When Domestic option is selected, only domestic cases will be included in the report.. When Foreign option is selected, only foreign cases will be included in the report. When both option is selected, both domestic and foreign cases will be included in the report.
			Foreign cases (radio button) 外国
			Both (両方)
Listedness from 既知未知判定		Listedness from	AER	If this option is selected then labeling information is considered from AER.
			CPD	If this option is selected then labeling information is considered from CPD. Applicable for MHLW Periodic Report and Unlabeled/Non-serious Report. The labeling information for Periodic Report Format 3 & 4, and Reexamination Report Format 4 & 5 is fetched from AER or CPD, based on the parameters set in the MHLW Runtime Selection Criteria page. The option selected in the MHLW Report Parameters page appears selected by default in the Selection Criteria page.

Header/No

Parameter

Values

Description

Query Name

検索条件名

Query Name

Text box

(Read-only mode)

Displays the name of the created selection criteria.

Click Save button, to edit the name.

Additional information

追加情報

Print AER number and Report date

AER番号と行政報告の出力

Yes

はい

You can specify this field to be printed in the report. Two radio buttons are provided to specify your choice.

If you select ‘Yes’ = AER number with version number in brackets and latest report date ("Date Informed" field in IA record) is printed in two different columns for MHLW Periodic Report Format 3.

If you select ‘No’ = AER number and latest report date ("Date Informed" field in IA record) is not printed in MHLW Periodic Report Format 3.

Default value is ‘No’.

This parameter is applicable for MHLW Periodic Report Format 4 only and not applicable for MHLW Periodic Report Format 3.

いいえ

Generate AER number file

AER番号一覧の出力

Yes

はい

You can specify your choice to generate AER number file by using the radio buttons.

If you select ‘Yes’ = Additional list with the Serial number, AER Number and latest report date ("Date Informed" field in IA record) is printed.

If you select ‘No’ = The file is not generated.

Default value is ‘Yes’.

This parameter is applicable for MHLW Periodic Report Format 4 only and not applicable for MHLW Periodic Report Format 3.

いいえ

記述

Shipment quantity classification

出荷薬剤の種類

Shipment quantity classification as needed to be printed in the reports

出荷薬剤の種類

You can enter the classification in the required format to be displayed in the report.

You can enter the multiple shipment classifications for each survey period by using navigation buttons.

The information entered in ‘Shipment quantity classification’ field is printed as label in field 56 (in the sample layout).

Shipment quantity(text box with navigation button)

出荷数量

Shipment quantity for each survey period

調査単位期間毎の出荷数量

You can enter shipment quantity for each survey period by using navigation buttons.

Each Shipment quantity is associated to each survey period entered in Selection sub-tab.

Footer

注釈

Multi line text

Enter the footer information for MHLW Periodic Report Format 3 and 4 separately. Footer is printed in the bottom and is left aligned.

Listedness from

既知未知判定

Listedness from

既知未知判定

AER

If this option is selected then labeling information is considered from AER.

CPD

If this option is selected then labeling information is considered from CPD.

Applicable for MHLW Periodic Report and Unlabeled/Non-serious Report.

The labeling information for Periodic Report Format 3 & 4, and Reexamination Report Format 4 & 5 is fetched from AER or CPD, based on the parameters set in the MHLW Runtime Selection Criteria page. The option selected in the MHLW Report Parameters page appears selected by default in the Selection Criteria page.

The selection criteria of Unlabeled/Non-Serious Report tab consist of two sub-tabs, Search Critera sub-tab and Layout sub-tab (レイアウト).

Header/No		Parameter	Values	Description
Query Name 検索条件名		Query Name	Text box (Read-only mode)	Displays the name of the created selection criteria. Click Save button, to edit the name.
Select product by one of the following 下記の製品条件の１つを入力してください。	1	Product Description (CPD look up)	Local trade name ローカル製品名	You can enter the local trade name for selecting and printing the report here. The CPD look up button will be provided along with this field so that you can select the trade name from the look up. Common Navigation button is provided to enter multiple trade names. Enter either trade name or Japanese drug codes only.
	2	Japanese Drug code (Japanese Drug Dictionary look up)	Japanese drug code 日本薬剤コード	You can enter the Japanese drug code for selecting and printing the report here. The CPD look up button will be provided along with this field so that you can select the trade name from the look up. Common Navigation button is provided to enter multiple Japanese drug codes. Enter either trade name or Japanese drug codes only.
Date range 調査単位期間	3	Date range 調査単位期間	From	Enter From date of the date range
Date range 調査単位期間	3	Date range 調査単位期間	To ＿＿～＿＿＿	Enter To date of the date range Future date is accepted in the survey period “To date” field of the MHLW LL selection criteria, and the report is generated accordingly. This is applied to the selection criteria of Unlabeled/Non-serious Report. In case of Unlabeled/Non-serious Report, the “To date” is printed in the CSV file 2 even if it is a future date. Date range is mandatory selection criteria to generate Unlabeled/Non-Serious Report.
Listedness from 既知未知判定	4	Listedness from 既知未知判定	AER	If this option is selected, then labeling information is considered from AER.
Listedness from 既知未知判定	4	Listedness from 既知未知判定	CPD	If this option is selected, then labeling information is considered from CPD. Applicable for MHLW Periodic Report and Unlabeled/Non-serious Report. The labeling information for Periodic Report Format 3 & 4, and Reexamination Report Format 4 & 5 is fetched from AER or CPD, based on the parameters set in the MHLW Runtime Selection Criteria page. The option selected in the MHLW Report Parameters page appears selected by default in the Selection Criteria page.

Header/No		Parameter	Values	Description
Query Name 検索条件名		Query Name	Text box (Read-only mode)	Displays the name of the created selection criteria. Click Save button, to edit the name.
Additional information	4	Print AER number and version number AER番号/バージョン番号の出力	Yes はい	You can specify this field to be printed in the report. Two radio buttons are provided to specify your choice. If you select ‘Yes’ = AER number with version number in brackets is printed in different column for Unlabeled/Non-serious Report. If you select ‘No’ = AER number and version number is not printed in Unlabeled/Non-serious Report.
Additional information	4	Print AER number and version number AER番号/バージョン番号の出力	No いいえ
Print	5	Therapeutic category 薬効分類	Text box	Enter the therapeutic category to be printed in Unlabeled/Non-serious Report.
	6	Indication text 効能又は効果	Multi line text	Enter the Indication Text to be printed in Unlabeled/Non-serious Report.
	7	Dosage and Administration 用法及び用量	Multi line text	Enter the Dosage and administration to be printed in Unlabeled/Non-serious Report.
	8	Content and dosage form 含量及び剤形	Multi line text	Enter the Content and dosage form to be printed in Unlabeled/Non-serious Report.
	9	Designated date 報告起算日	Single line text	Enter the designated date to be printed in the Unlabeled/Non-serious Report.
	10	Current/future safety measures 集積結果を踏まえた安全確保措置及び今後の安全対策	Multi line text	Enter the current/future safety measures in the text box to be printed in the Unlabeled/Non-serious Report.
	11	Remarks 備考	Multi line text	Enter the remarks in the text box to be printed in Unlabeled/Non-serious Report.
	12	Footer 注釈	Multi line text	Enter the footer information in the text box to be printed in Unlabeled/Non-serious Report.
Sender/Receiver 送信者/受信者	13	Sender address　報告者の住所	Multi line text	Enter Sender address in the field.
Sender/Receiver 送信者/受信者	14	Sender name (Person Lookup)　報告者の氏名	Multi line text	Select the Sender name from lookup button (person lookup). Last name and First name is separated by a space on selecting from the lookup.
File name ファイル名	15	Unique folder name 固有のフォルダ名	Single line text	You can enter the “Unique folder name” for naming the CSV files. The CSV files will be generated with file names as <Unique folder name>_1.CSV, <Unique folder name>_2.CSV and <Unique folder name>_3.CSV. If the field is left blank during report generation, a message “Folder Name cannot be empty” will be prompted.
Print previously reported reactions 報告済副作用の出力	16	Print prefixed with + (+を付け出力) Print without + (+なしで出力) Don’t print (出力しない)	Print prefixed with + (+を付け出力) Print without + (+なしで出力) Don’t print (出力しない)	You can specify this field to be printed in the report. Three radio buttons are provided to specify your choice. If the option is set ‘Print prefixed with +’ previously reported reactions are printed prefixed with ‘+’. By default this option is specified. If the option is set ‘Print without +’ previously reported reactions are printed without ‘+’. If the option is set ‘Don’t print’, previously reported reactions are not printed. However this is same as printing newly reported reaction.

The selection criteria of Reexamination Report consist of two sub-tabs, Search Criteria sub-tab and Layout sub-tab (レイアウト).

Header/No		Parameter	Values	Description
Query Name 検索条件名		Query Name	Text box (Read-only mode)	Displays the name of the created selection criteria. Click Save button, to edit the name.
Select one product by from the following 下記の製品条件の１つを入力してください。	1	Local Poduct Name (CPD look up)	Local trade name ローカル製品名	You can enter or select the local product name with the help of the CPD look up available on the right corner of this field. Common Navigation button is provided to enter multiple trade names. Enter either trade name or Japanese drug codes only.
	2	Japanese Drug code (Japanese Drug Dictionary look up)	Japanese drug code 日本薬剤コード	You can enter the Japanese drug code for selecting and printing the report here. The CPD look up button will be provided along with this field so that you can select the trade name from the look up. Common Navigation button is provided to enter multiple Japanese drug codes. Enter either trade name or Japanese drug codes only.
	3	Reexamination Period	From	Enter From date of the date range
	3	Reexamination Period	To ＿＿～＿＿＿	Enter To date of the date range Future date is accepted in the survey period “To date” field of the MHLW LL selection criteria, and the report is generated accordingly. This is applied to the selection criteria of Unlabeled/Non-serious Report. In case of Unlabeled/Non-serious Report, the “To date” is printed in the CSV file 2 even if it is a future date. Date range is mandatory selection criteria to generate Reexamination Report.
	4	Reexamination Report	Research Report Index (old Form 7)
			Unexpected ADR/infection case report list (Form 9)
			Measures-taken Report Index (Form 13) / Research Report Index (Form 14)

Report Parameters

A new Report parameters menu item – “MHLW Line Listing Reports” is added under Parameters->Report parameters. Click on this Option the screen “MHLW Line Listing Reports” is invoked. There are two tabs with General and Layout.

No	Parameter	Japanese parameter	Values	Japanese values	Default value	Description
1	SOC from	使用するSOC	AER	AER	AER	SOC is considered from the AER, if AER option is selected.
1	SOC from	使用するSOC	Dictionary	辞書	AER	SOC is considered from MedDRA Dictionary, if Dictionary option is selected. Applicable for MHLW Periodic Report Format 3
2	Seriousness as per	重篤度判定	Reporter	報告者	Company	Seriousness is considered from Reporter’s Assessment, if Reporter option is selected.
			Company	企業		Seriousness is considered from Company assessment, if Company option is selected.
			Both	両方		This option is set, if the case is considered as serious either of the seriousness field (i.e. Reporter’s assessment or Company assessment) is set to Serious. Applicable for Unlabeled/Non-serious Report
3	Onset date	発現日	As per reporter	報告者	As per company	Select the option As per reporter to get the date
			As per company	企業		Select the option As per company to get the date
			As per company if reporter onset date not available	報告者の発現日がない場合は企業		Select the option to get the date As per company if reporter onset date not available. Applicable for Periodic Report Format 4 and Unlabeled/Non-serious Report
4	Restart serial number in each survey period	調査単位期間毎の連番	Yes	はい	No	Select Yes to get the Restart serial number in each survey period
4	Restart serial number in each survey period	調査単位期間毎の連番	No	いいえ	No	Continuous serial numbers is printed in all the survey periods, as this parameter is set to “No”. Applicable for Periodic Report Format ４
5	Count initial and follow up cases	初回/追加報告集積方法	Together	同一調査単位期間	Together	Select “Together”, the cases are counted together.
5	Count initial and follow up cases	初回/追加報告集積方法	Separate	異なる調査単位期間	Together	Select “Separate”, the cases are counted separately. Applicable for MHLW Periodic Report
6	Print follow up information in	追加報告情報の出力	First reporting period	初回報告日	Current reporting period	Select “First reporting period”, all the reactions available in the latest version of a case are counted in first reporting period.
6	Print follow up information in	追加報告情報の出力	Current reporting period	最新報告日	Current reporting period	Select “Current reporting period”, newly added reactions should be included in the survey period of the latest case version. Applicable for MHLW Periodic Report
7	Consider onset date for comparing AE’s (R3/R4)	AE（R3/R4）の比較に対し発現日を考慮する	Yes No	はいいいえ	No	Select Yes for considering the Onset date along with LLT code, PT code, and SOC code for comparing lower version of valid AE with higher version of AE. Select No for not considering the Onset date for comparison.
8	Print Study information in study column	承認時迄の状況の出力	Yes	はい	No	Select “Yes”, the study cases are printed in the first column.
8	Print Study information in study column	承認時迄の状況の出力	No	いいえ	No	Select “No”, the study cases are not printed in the first column. Applicable for MHLW Periodic Report Format 3
9	Listedness from	既知未知判定	AER	AER	AER	If this option is selected then labeling information will be considered from AER.
9	Listedness from	既知未知判定	CPD	CPD	AER	If this option is selected then labeling information will be considered from CPD. Applicable for MHLW Periodic Report and Unlabeled/Non-serious Report. The labeling information for Periodic Report Format 3 & 4, and Reexamination Report Format 4 & 5 is fetched from AER or CPD, based on the parameters set in the MHLW Runtime Selection Criteria page. The option selected in the MHLW Report Parameters page appears selected by default in the Selection Criteria page.
10	Consider causality	因果関係考慮	Yes	はい	Yes	The causality field, “Assess relationship?” value is considered to be included in the reports. “Assess relationship” flag is set to Yes to prepare the report for the drug with causality record by counting the reactions.
10	Consider causality	因果関係考慮	No	いいえ	Yes	The causality field, “Assess relationship?” value is not considered for including reaction count in the reports. Applicable for Periodic Report and Unlabeled/Non-serious Report
11	Print age group for age	年代出力	Yes	はい	No	If this parameter is set to “Yes” the age group in the age column will be printed on MHLW Periodic Report Format 4 if age or age unit or both is not available.
11	Print age group for age	年代出力	No	いいえ	No	If this parameter is set to “No” “不明” (unknown) will be printed in the age column on MHLW Periodic Report Format 4 if age or unit is not available. Not Applicable for Periodic Report Format 3
12	Print AER number for serial number in Unlabeled/Non-serious Report	未知非重篤定期報告番号欄出力値	Yes	AER番号	AER番号	AER number of the case is printed for all the reactions instead of the serial number as the parameter is set to “Yes”.
12		未知非重篤定期報告番号欄出力値	No	連番	AER番号	Serial number will be printed for all the reactions as the parameter is set to “No”.
13	Outcome	転帰	As per reporter	報告者	As per company	A new Report parameter Outcome is added. If it is set to as per reporter, then Outcome is considered from Reporter’s assessment.
13	Outcome	転帰	As per company	企業	As per company	If Outcome is set to as per company, then Outcome is considered from company assessment Applicable for Periodic Report Format 4 and Unlabeled/Non-serious Report
14	Labeling country for MHLW Periodic Report	既知未知判定国（安全性定期報告）	All Countries with combo box			Consider the labeling information from the record corresponding to this country. When no labeling record found for this country entered in the parameter, then consider the labeling record for country “Japan” for MHLW Periodic report.
15	Labeling country for Unlabeled/Non-serious Report	既知未知判定国（未知非重篤定期報告）	All Countries with combo box			Consider the labeling information from the record corresponding to this country. When no labeling record found for this country entered in the parameter, then consider the labeling record for country “Japan” for Unlabeled/Non-serious Report.
16	Include study cases in survey period	市販後調査単位期間に治験症例を含む	Yes	はい	Yes	Select “Yes”, the study cases are printed in the survey period columns. This is applicable for MHLW Periodic report.
16	Include study cases in survey period	市販後調査単位期間に治験症例を含む	No	いいえ	Yes	Select “No”, the study cases are not printed in the survey period columns. This is applicable for MHLW Periodic report.
17	Consolidate Drugs in MHLW LL	MHLWラインリストでの薬剤の統合	Yes	はい	Yes	Counts an Adverse Event only once, when two products consists one JPN drug code. Counts an Adverse Event as two, when two products consists one JPN drug code.
18	Ignore not relevant flag	関連無しフラグを参照しない	MHLW Periodic Report(checkbox)	安全性定期報告	Unchecked	Check the parameter to ignore not relevant flag for MHLW Periodic reports
			Unlabeled/Non-serious Report(checkbox)	未知非重篤定期報告	Unchecked	Check the parameter to ignore not relevant flag for Unlabeled/Non-Serious Report
			Reexamination Report(checkbox)	再審査申請別紙様式７	Unchecked	Check the parameter to ignore not relevant flag for Reexamination Report Format 7

MHLW Periodic report and E2B reports considers “Not reportable in Japan” flag.

Unlabeled/Non-Serious Report will not consider “Not reportable in Japan” flag.

Following table describes each parameter’s attributes and functionality in Layout tab.