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Category: Guidances

Anvisa Establishes New Rules for Labeling Personal Care Products, cosmetics and perfumes.

Anvisa Approves Rules for Labeling Personal Care Products, cosmetics and perfumes. RDC 751/2022

The Brazilian Health Regulatory Agency (ANVISA) issued the regulation RDC No. 752/2022 Labeling rules for Cosmetics in Brazil.

Brazil’s Anvisa Updates Medical Device Regulations with RDC 751/2022.

Anvisa Approves Rules for Labeling Personal Care Products, cosmetics and perfumes.

The Brazilian Health Regulatory Agency (ANVISA) issued the new medical device regulation RDC No. 751/2022 on Sept. 21, 2022.

US FDA Issues Rule to Streamline Radiological Health Regulations

On January 2023, The U.S. Food and Drug Administration (FDA) published Radiological Health Regulations for Recording

On January 2023, The U.S. Food and Drug Administration (FDA) published Radiological Health Regulations for Recording and Reporting Radiation Emitting Electronic Products and Performance Standards for X-ray, Laser and Ultrasonic Diagnostic Products.

US FDA Proposes Fee Increases for Certification Services on Color Additives

US FDA Proposes Fee Increases for Certification Services on Color Additives

On January 2023, The U.S. Food and Drug Administration (FDA) has issued a proposed rule to amend color additive regulations to increase fees for certification services. ves

Japan’s MHLW Publishes New Quality Standards for Quasi-Drugs

Japan's MHLW Publishes New Quality Standards for Quasi-Drugs

On October 2022, the Japanese Ministry of Health, Labour and Welfare (MHLW) has published new quality standards and specifications of 2,647 ingredients and additives that can used in Quasi-drugs.

FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation

FDA Issues Draft Guidance for Industry, Considerations for Rescinding Breakthrough Therapy Designation

The U.S. FDA issued a draft guidance for industry titled Considerations for Rescinding Breakthrough Therapy Designation.

Brazil’s Anvisa authorizes Remdesivir for Pediatric- Use in the treatment of Covid-19

Anvisa approved, on Monday (11/21), the extension of use of the antiviral drug Remdesivir for pediatric use in the treatment of Covid-19.

USFDA Publishes updated definitions FOR ‘Face-to-Face Meeting’

The FDA publishes updated Definitions of Face‑to‑Face Formal Meetings.

Brazil’s ANVISA Approves new Normative for the Registration of New and Innovative Medicines

On October 2022 Anvisa publishes approval measures for the registration of new and innovative medicines in Brazil

FDA-Advancing Real World Evidence Program

In October 2022, the U.S. Food and Drug Administration is announcing the Advancing Real-World Evidence (RWE) Program

China’s NMPA Announces they will Start Electronic system for Drug related Registration Certificates (2022)

China’s NMPA Announces they will start on Issuance of Drug Electronic Registration Certificates starting November 1st, 2022. China’s National Medical Products Administration (NMPA) will issue drug registration certificates in electronic version, which is as legally valid as the paper version.

Brazil’s ANVISA Announces Medical Device Registration 2022 Updates

ANVISA Brazil announced in early September 2022 important updates to its Collegiate Directorate Resolution (RDC) 185/2001.
The changes strengthen the country’s medical device registration regulations on the effective date of March 1, 2023.

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