• China's NMPA Finalizes Administrative Measures on Cosmetics Labeling and Prohibited Claims

    Prepare the Labels Accordingly.

    Measures Will Be Effective from
    May 1, 2022

  • EU Mandates Harmonized PCN Format for Hazardous Chemical Mixtures

    Align with the Mandatory Deadlines Now!

    January 1, 2024 (for Mixtures for industrial use)

    January 1, 2025 (Mixtures already notified under the National Legislation)

  • Health Canada Has Started Accepting XML Product Monographs On a "By Request" Basis

    • It Is Effective From April 1, 2020 to July 31, 2020

    File XML Product Monographs Now!

    Deadline: April 1, 2020 to July 31, 2020

  • 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

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