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Health Canada Has Started Accepting XML Product Monographs On a "By Request" Basis
- It Is Effective From April 1, 2020 to July 31, 2020
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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.
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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
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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