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医薬品等の承認又は許可等に係る申請等における電磁的記録及び電子署名の利用について。
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| 医薬品、医薬部外品、化粧品及び医療機器(以下「医薬品等」という。〉の承認又は許可等並びに適合性認証機関の登録等に係る申請、届出又は報告等(以下「申請等」という。)に関する資料及び当該資料の根拠となるいわゆる原資料(以下「原資料」という。)について、今般、下記のとおり、電磁的記録により資料及び原資料を提出又は保存する場合の留意事項をとりまとめたので、御了知の上、貴管下関係業者に対し指導方ご配慮願いたい。 なお、本通知の写しを、日本製薬団体連合会会長等の関係団体の長あてに送付していることを申し添える。 |
1． 趣旨
医薬品等の申請等に関する資料については、行政手続等における情報通信の技術の利用に関する法律(平成14年法律第151号)及び民間事業者等が行う書面の保存等における情報通信の技術の利用に関する法律(平成16年法律第149号。以下「e-文書法」という。)により電磁的記録による申請や保存が認められている。また、厚生労働省に提出する資料については、「個別症例安全性報告を伝送するためのデータ項目及びメッセージ仕様について」(平成13年3月30日付医薬安発第39号・医薬審発第334号厚生労働省医薬局安全対策課長・審査管理課長通知)及び「「コモン・テクニカル・ドキュメントの電子化仕様について」の一部改正について」(平成16年5月27日付薬食審査発第0527001号厚生労働省医薬食品局審査管理課長通知)において電磁的記録による提出様式が定められているところである。
上記の法令及び通知により、医薬品等の申請等においても、申請者等が提出する資料については電磁的記録により対応することが可能であるが、薬事法の趣旨を踏まえ、電磁的記録による申請資料等の信頼性を確保するため、今般、電磁的記録により資料及び原資料を提出又は保存する場合等の留意事項を定めることとしたものであること。
2． 電磁的記録及び電子署名を利用する際の要件
薬事法の申請等に係る資料及び原資料を作成する際に、電磁的記録及び電子署名を利用する場合には、別紙の指針に基づいて利用すること。
3． 適用範囲
別紙の指針は、以下の場合に適用すること。
(1)薬事法及び関連法令に基づいて、医薬品、医薬部外品、化粧品及び医療機器の承認又は許可等並びに適合性認証機関の登録等に係る申請、届出又は報告等にあたって提出する資料として電磁的記録又は電子署名を利用する場合
(2)原資料、その他薬事法及び関連法令により保存が義務づけられている資料として電磁的記録及び電子署名を利用する場合
なお、薬事法及び関連法令に基づいて、医薬品、医薬部外品、化粧品及び医療機器の承認又は許可等並びに適合性認証機関の登録等に係る申請、届出又は報告等にあたって提出する資料、原資料、その他薬事法及び関連法令により保保存が義務づけられている資料を紙媒体で作成する際に電磁的記録及び電子署名を利用する場合にあっても、可能な限り本指針に基づくことが望ましいこと。
4． 適用期日
本指針は、原則として平成17年4月1日以降に提出又は保管される資料について適用することとすること。
５． 指針の見直し
本指針は、技術的な進歩及び海外の規制状況等の変化を考慮して、必要に応じて見直すこととすること
別紙
医薬品等の承認又は許可等に係る申請等に関する電磁的記録・電子署名利用のための指針
1．目的
本指針は、医薬品、医薬部外品、化粧品及び医療機器(以下「医薬品等」という)の承認又は許可等並びに適合性認証機関の登録等に係る申請、届出又は報告等(以下「申請等」という)に関する資料及び原資料について、電磁的記録及び電子署名を利用する際の必要な要件を定めたものである。
2．用語の定義
本指針で用いる用語の定義は、「民間事業者等が行う書面の保存等における情報通信の技術の利用に関する法律」によるものの他、次のとおりとする。
- 電磁的記録媒体
磁気ディスク、光ディスク、磁気テープ等の、電磁的記録を保管するためのもの。 - 電子署名
電磁的記録に対し、手書き署名又は捺印と同等のものとして行われる署名で、個人又は法人が作成、採用、確認、承認する一連の記号を電子化して構成したデータ。 - デジタル署名
署名者認証の暗号化技術等に基づく電子署名。 - クローズド・システム
システム内の電磁的記録に責任を持つ者によって、システムへのアクセスが管理されているシステム。 - オープン・システム
システム内の電磁的記録に責任を持つ者によって、システムへのアクセスが管理されていないシステム。 - 監査証跡
正確なタイム・スタンプ(コンピュータが自動的に刻印する日時)が付けられた一連の操作記録。
3．電磁的記録利用のための要件
3.1. 電磁的記録の管理方法
電磁的記録利用システムとそのシステムの運用方法により、次に掲げる事項が確立されていること。この場合、電磁的記録利用システムはコンピュータ・システム・バリデーションによりシステムの信頼性が確保されている事を前提とする。
3.1.1. 電磁的記録の真正性
電磁的記録が完全で、正確で、信頼できるとともに、作成、変更、削除の責任の所在が明確であること。
真正性を確保するためには、以下の要件を満たすことが必要である。
- システムのセキュリティを保持するための規則、手順が文書化されており、適切に実施されていること。
- 保存情報の作成者が明確に識別できること。また、一旦保存された情報を変更する場合は、変更前の情報も保存されるとともに、変更者が明確に識別できること。なお、監査証跡が自動的に記録され、記録された監査証跡は予め定められた手順で確認できることが望ましい。
- 電磁的記録のバックアップ手順が文書化されており、適切に実施されていること。
3.1.2. 電磁的記録の見読性
電磁的記録の内容を人が読める形式で出力(ディスプレイ装置への表示、紙への印刷、電磁的認録媒体へのコピー等)ができること。
3.1.3. 電磁的記録の保存性
保存期間内において、真正性及び見読性が確保された状態で電磁的記録が保存できること。
保存性を確保するためには、以下の要件を満たすことが必要である。
- 電磁的記録媒体の管理等、保存性を確保するための手順が文書化されており、適切に実施されていること。
- 保存された電磁的記録を他の電磁的記録媒体や方式に移行する場合には、移行された後の電磁的紀録についても真正性、見読性及び保存性が確保されていること。
3.2. クローズド・システムの利用
電磁的記録を作成、変更、維持、保管、取出または配信をするためにクローズド・システムを利用する場合は、3.1に記載された要件を満たしていること。また、電子署名を使用する場合には、4.に記載された要件を満たしていること。
3.3. オープン・システムの利用
電磁的記録を作成、変更、維持、保管、取出または配信をするためにオープン・システムを利用する場合は、3.1に記載された要件に加え、電磁的記録が作成されてから受け取られるまでの間の真正性、機密性を確保するために必要な手段を適切に実施すること。追加手段には、電磁的記録の暗号化やデジタル署名の技術の採用などが含まれる。さらに、電子署名を使用する場合には、4.に記載された要件を満たしていること。
4．電子署名利用のための要件
電子署名を利用する場合は、電子署名の信頼性を確保するために、以下の要件を満たすこと。
- 電子署名及び認証業務に関する法律(平成12年5月31日法律第102号)に基づき、電子署名の管理・運用に係る手順が文書化されており、適切に実施していること。
- 電子署名は、各個人を特定できる唯一のものとし、他の誰にも再使用、再割当しないこと。
- 電磁的記録による資料について電子署名を使用する場合は、署名された電磁的記録には以下の全項目を明示する情報が含まれていること。
- 署名者の氏名
- 署名が行われた日時
- 署名の意味（作成、確認、承認等）
- 電磁的記録に付された電子署名は、不正使用を防止するため、通常の方法では削除・コピー等ができないように、対応する各々の電磁的記録とリンクしていること。
5．その他
医薬品等の承認又は許可等並びに適合性認証機関の登録等に係る申請等に関する資料及び原資料について電磁的記録及び電子署名を利用しようとする者は、電磁的記録及び電子署名の利用のために必要な責任者、管理者、組織、設備及び教育訓練に関する事項を規定しておくこと。
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