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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.
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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
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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
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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
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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
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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
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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
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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.
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The USFDA has extended the Type III DMF’s eCTD submission deadline
- - May 5, 2020 has been mandated as the new deadline
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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.
