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On November 8, 2023, the Food and Drug Administration (FDA) announced that it will be ready to accept registration and listing information for the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by the statutory deadline of December 29, 2023 and encourages companies to meet that deadline.
Following a lengthy period of anticipation, Health Canada has released Draft Guidance Document Preparation of the Product Monograph in Extensible Markup Language (XML) Format and sample files.
On August 7, 2023, the Food and Drug Administration (FDA) released draft guidance providing recommendations and instructions pertaining to the collection and submission of information related to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), specifically, to assist persons submitting cosmetic product facility registrations and product listings to FDA.
Effective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the second language product monograph at the time of submission filing or review. However, both English and French languages need to be on the Drug Product Database (DPD) online and Drug and Health Product Portal (DHPP).
LexisNexis® Reed Tech, a leading provider of regulatory submissions, data management, and analytics solutions for the life sciences industry, is expanding its services portfolio to offer end-to-end eCTD solutions and services to support manufacturers, distributors,...
Over the years, Global Health Authorities have begun to work towards regulatory harmonization. Of course, the World Health Organization (WHO), a special agency of the United Nations responsible for international public health and established in 1948, is often at the...
Effective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the second language product monograph at the time of submission filing or review. However, both English and French languages need to be on the Drug Product Database (DPD) online and Drug and Health Product Portal (DHPP).
Pharma manufacturers and authorized distributors need to submit distribution reports electronically in an eXtensible Markup Language (XML) format to comply with the guidance entitled Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act. This guidance fulfills the Drug Sample Transparency Act specification of ACA Section 6004. These amounts must be reported each year by April 1st for the previous calendar year.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law on December 29, 2022. This law, which provides a major overhaul of existing cosmetic regulations, requires the Food and Drug Administration (FDA) to create Good Manufacturing Practices for all cosmetics manufacturers. The law states that these established practices must include mandatory reporting of serious adverse health events caused by cosmetic products and mandatory testing of asbestos levels. This law will also include updates to cosmetic listing requirements.
As of December 28, 2022, all new REMS (Risk Evaluation and Mitigation Strategy) submissions and all REMS updates will be required to be submitted in SPL (Structured Product Labeling) format per the FDA. This is in compliance with the Final Guidance on REMS issued by...