• 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

    Consult
    TGA | Pharmaceuticals | Regulatory Labeling

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

    • - January 1, 2020 is the mandatory deadline

    Switch to the eCTD format, RIGHT NOW!

    Deadline: Jan 1, 2020

    Consult
    EDQM | Pharmaceuticals | Publishing & Submissions

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

    • - It is already been effective from March 1, 2019

    Adapt to the JO eCTD format right now!

    Deadline: Mar 1, 2019

    Consult
    JFDA | Pharmaceuticals | Publishing & Submissions

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

    • - It will be mandatory 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?

    Deadline: Jan 1, 2020

    Consult
    HALMED | Pharmaceuticals | Publishing & Submissions

  • 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.

    Deadline: Jan 1, 2020 & Jan 1, 2021

    Consult
    USFDA | Nutraceuticals/Food Supplements | Regulatory Labeling

  • 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

    Consult
    CDSCO | Medical Devices | Regulatory Affairs

  • The USFDA has extended the Type III DMF’s eCTD submission deadline

    • - May 5, 2020 has been mandated as the new deadline

    How compliant are your eCTD conversions?

    Deadline: May 5, 2020

    Consult
    USFDA | Pharmaceuticals | Publishing & Submissions

  • EMA’s new EU MDR will be effective from May 26, 2020.

    • 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!

    Deadline: May 26, 2020

    Consult
    EMA | Medical Devices | Regulatory Affairs

  • The TGA has 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 is the transition deadline.

    Would you like to comply with the new standards?

    Deadline: Aug 31, 2020

    Consult
    TGA | Pharmaceuticals | Regulatory Labeling

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

    • - The transition deadline is December 31, 2020

    Would you like to reformat the existing PIs?

    Deadline: Dec 31, 2020

    Consult
    TGA | Pharmaceuticals | Regulatory Labeling

Pages