• 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.

    Effective Since: 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 Since:
    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.

    Effective Since: 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 ended on April 30, 2020

    Let your medicine labels showcase new ingredient names.

    Effective Since: Apr 30, 2020

  • EMA’s New EU MDR is effective since May 26, 2021.

    • In accordance, manufacturers must submit a Clinical Evaluation Report (CER) along with CE Technical File.

    Don’t give it a miss.
    Act now to be compliant!

    Effective Since: May 26, 2021

  • The TGA introduced new labeling requirements for medicines supplied in Australia.

    • - TGO 91 for standard labels of prescription and related medicines
    • - TGO 92 for standard labels of non-prescription medicines
    • Aug 31, 2020 was the transition deadline.

    Would you like to comply with the new standards?

    Effective Since: Aug 31, 2020

  • Australia’s TGA has announced new Product Information (PI) Form, which is mandatory.

    • - It is Effective Since December 31, 2020

    Would you like to reformat the existing PIs?

    Effective Since: Dec 31, 2020

  • Health Canada has announced amendments to nutrition labeling, list of ingredient and food colours.

    • - The transition deadline for new requirements ends on December 14, 2022

    Would you like to adopt the
    new requirements?

    Deadline: Dec 14, 2022

Pages