News

Proregulations Announces Participation in the 2024 CPHI North America Conference

The 2024 CPHI North America Conference is scheduled to be held at the Pennsylvania Convention Center in Philadelphia, a heavy industrial city in the United States, on May 7-9, 2024 (local time). Proregulations will participate in CPHI North America Conference, and our booth number is 651…

Proregulations Announces Participation in DCAT Week 2024

We are excited to participate in DCAT Week 2024, scheduled for March 18-21, 2024 (local time) in New York City. During DCAT Week 2024, we will be in Converted Room #1415, Lotte NY Palace Hotel, 455 Madison Ave, New York, NY 10022…

Guidance for Industry New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements

On March 5, 2024, FDA announced the availability of final guidance for industry titled "Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements | FDA". This guidance is intended to help…

FDA Guidance Breakdown: Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

On 5 February 2024, FDA issued draft guidance intended to assist applicants and manufacturers in providing FDA with timely, informative notifications of changes in the production of certain finished drugs and biologics and certain APIs…

The FDA Announces Additional Submission Tools Are Now Available for Cosmetic Product Listing and Facility Registration

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires the registration of cosmetic product facilities and the listing of cosmetic products. On January 8, 2024, the FDA announced the availability of SPL Xforms, an authorization tool for Structured Product Labeling (SPL)…

FDA ASCA Program-Accreditation Scheme for Conformity Assessment

Accreditation Scheme for Conformity Assessment," or "ASCA," is a new program that the U.S. Food & Drug Administration (FDA) introduced in September 2020. This voluntary program was…

FDA Issues Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which will go into effect on December 29, 2023, requires the reporting of serious adverse events in cosmetics. The U.S. Food and Drug Administration (FDA) gave an update on December 14, 2023…

FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities&Products Required under MoCRA, and Launched Cosmetic Direct.

On December 18, 2023, the U.S. Food and Drug Administration (FDA) issued two announcements regarding the law of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), specifically concerning the requirements for cosmetic facility registration and cosmetic product listing…

Major Update to US Cosmetic Regulations: The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) - Introduction to Key Terms and Regulations

Every day, most American consumers use cosmetic products. These products include makeup, perfumes, face and body cleaners, hair products and other skincare or grooming products. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant reform of cosmetic laws in U.S. MoCRA expands the U.S. FDA regulatory authority over the cosmetic…

America's Compulsory Registration System for Cosmetics is Coming. FDA Stopped Using the VCRP System!

On March 27, 2023, the FDA announced that it stopped receiving and processing both paper and electronic submissions to the Voluntary Cosmetic Registration Program (VCRP) and said that the FDA is developing a new system for submitting cosmetic industry facility registrations and product filings which mandated by the Cosmetic Regulatory Modernization Act of 2022 (MoCRA)…