• The Committee of the Eurasian Economic Union (EAEU) Mandated Electronic Submissions

    Mandatory deadline:

    • - New Market Authorizations - Dec 31, 2020.
    • - Follow-up Submissions – Dec 31, 2025.

    Switch to eCTD format, NOW!

    New Market Authorizations - Dec 31, 2020.

    Follow-up Submissions – Dec 31, 2025.

  • Indonesia’s BPJPH Mandated HALAL labeling for food and cosmetic products

    Mandatory deadline:

    • - Food Products: October 17, 2024.
    • - Cosmetic Products: October 17, 2026.

    Align Your Product Labels Accordingly.

    Food Products:
    Effective From - October 17, 2024.
    Cosmetic Products:
    Effective From - October 17, 2026.

  • Australia’s TGA Sets Mandatory Deadline for Stage 3 Implementation of eCTD Format for Prescription Drug Dossier Submissions

    • - July 1, 2020 is the mandatory deadline

    Switch to the eCTD format, RIGHT NOW!

    Effective From:
    July 1, 2020

  • Health Canada mandates eCTD format for all new Type I, II, III, IV Master File Submissions.

    • - It is already in effect from Jan 1, 2020.

    Convert existing applications into eCTD.

    Effective Since: Jan 1, 2020.

  • EDQM has announced that eCTD is mandatory for all CEP applications including notifications, revision, renewal and new applications.

    • - It is already in effect from January 1, 2020 is the mandatory deadline

    Switch to the eCTD format, RIGHT NOW!

    Effective Since: Jan 1, 2020

  • Croatia’s Health Authority, HALMED, has announced the adaptation of eCTD documentation.

    • - It is already in effect from Jan 1, 2020
    • - It is expected to apply for all types of claims in national drug authorization procedures

    Would you like to consider converting to eCTD?

    Effective Since: Jan 1, 2020

  • USFDA has extended the compliance dates for nutritional facts and supplement facts label

    • - Manufacturers with > $10M annual food sales must switch to the new label by January 1, 2020
    • - Manufacturers with < $10M annual food sales must comply with the new label by January 1, 2021

    Switch to the new label.

    Transition Deadline: Jan 1, 2020 & Jan 1, 2021

  • Jordan Food and Drug Administration (JFDA) has started accepting JO eCTD format (Version 1.0.2) for marketing authorization submissions.

    • - It is already in effect from March 1, 2019

    Adapt to the JO eCTD format right now!

    Effective From:
    Mar 1, 2019

  • CDSCO, India has included 8 new device types to the list of regulated Medical Devices.

    • - From April 1, 2020, the newly listed devices should be mandatorily registered & foreign manufacturers must obtain an Import License

    Check which regulated category
    does your device fall under.

    Deadline: Apr 1, 2020

  • TGA has asked all the affected sponsors to update their medicine labels and relevant documentation in accordance with the new ingredient names.

    • - The transition period ends on April 30, 2020

    Let your medicine labels showcase new ingredient names.

    Deadline: Apr 30, 2020

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