11/21付でオーストラリアTGAから「General dossier requirements」と題して、各種提出資料に関するガイダンスがバージョン1.2に更新されたと通知されています。
ちなみに、以下に記されているARTGとは“Australian Register of Therapeutic Goods”のことです。
以下の資料について適用するとしています。
●To register a medicine (prescription, OTC or complementary) on the ARTG
●To include a biological on the ARTG that requires evaluation of information
●To include a medical device (including IVD) on the ARTG if you have been advised that it will be audited and requested to provide information for the audit
●For medical device (including IVD) conformity assessment certification
●To vary the ARTG record which requires supporting information
一方で、以下の資料は適用外としています。
●To list a complementary or OTC medicine (information is not required for evaluation)
●To include medical device on the ARTG (other than those selected for audit).
●To vary the ARTG record if supporting information is not required.
Note: An application for a variation to a prescription medicine will be submitted as an eCTD sequence.
●For Good Manufacturing Practice (GMP) certification or GMP clearance of overseas manufacturers.
関係者にあっては、下記URLのウェブサイトをご参照ください。
https://www.tga.gov.au/publication/general-dossier-requirements
ちなみに、以下に記されているARTGとは“Australia
以下の資料について適用するとしています。
●To register a medicine (prescription, OTC or complementary) on the ARTG
●To include a biological on the ARTG that requires evaluation of information
●To include a medical device (including IVD) on the ARTG if you have been advised that it will be audited and requested to provide information for the audit
●For medical device (including IVD) conformity assessment certification
●To vary the ARTG record which requires supporting information
一方で、以下の資料は適用外としています。
●To list a complementary or OTC medicine (information is not required for evaluation)
●To include medical device on the ARTG (other than those selected for audit).
●To vary the ARTG record if supporting information is not required.
Note: An application for a variation to a prescription medicine will be submitted as an eCTD sequence.
●For Good Manufacturing Practice (GMP) certification or GMP clearance of overseas manufacturers.
関係者にあっては、下記URLのウェブサイトをご参照ください。
https://www.tga.gov.au/
執筆者について
経歴 ※このプロフィールは掲載記事執筆時点での内容となります
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