Global Health Authority Mandates

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.

Indonesia’s BPJPH Mandated HALAL labeling for food and cosmetic products

Mandatory deadline:

• - Food Products: October 17, 2024.
• - Cosmetic Products: 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

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.

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

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

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

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

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

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