Brazil’s Anvisa confirms “Superfungus” Outbreak of Candida Auris in Brazil
Brazil’s National Health Surveillance Agency (Anvisa) informs that, on Tuesday (11/1), the third outbreak of the Candida auris fungus in Brazil was confirmed. The case occurred in a hospital in Pernambuco (PE)
The US-FDA Releases White Paper on Testing Methods for Asbestos in Cosmetic Products Containing Talc
On January 13, 2022 , the U.S Food and Drug Administration (FDA) made available the white paper titled IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc (including Talc Intended for Use in Cosmetics).
Brazil’s Chamber for Drug Market Regulation discloses the annual price adjustment for drugs
On January 10th, 2022, Brazil’s Technical-Executive Committee of the Drugs Market Regulation Chamber (CMED) set at 0% (zero percent) the value of the productivity factor (Factor X) referring to the adjustment of drug prices for the year 2022.
Brazil’s Anvisa Updates the List of Brazilian Common Appellations
The Resolution RDC No. 590/2021 published on December 29th, 2021, the List of Brazilian Common Denominations (DCBs). The regulation included 28 new designations and changed two.
The US-FDA Launches New Reportable Food Registry (RFP)
On January 5, 2022, The FDA published a new, interactive public data dashboard that allows anyone to view historical data from the Reportable Food Registry (RFR).
The US FDA deems final Order for Sunscreens
On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.
The US-FDA Grants Citizen Petition on Acacia (Gum Arabic) as a Dietary Fiber
On December 17, 2021, The U.S. Food and Drug Administration (FDA) recently granted a citizen petition concerning the classification of acacia (Gum Arabic) as a dietary fiber.
THE US-FDA: VQIP Application Portal Now Open for FY 2023
On December 1, 2022, the U.S.FDA will Open the Voluntary Qualified Importer Program (VQIP) application portal for fiscal year (FY) 2023.
US-FDA Announces New Requirements to Facilitate Export of Food Under China New Registration – Decree 248
On December 6, 2021 the FDA announced that establishments currently exporting certain food products to China to voluntarily submit information. The FDA is implementing this request in response to new facility registration requirements from China.
Regulatory Overview: Registration of Toothpaste in China
On October 21, 2021, the Chinese health authority (NMPA) has published a new regulation related to the requirements of Local testing as part of medical devices registration in China: “Regulations on the Administration of Medical Device Registration and Self-inspection”
Brazil’s Anvisa approves eighth cannabis-based medicinal product
Resolution RDC No.327/2019 establishes requirements for the marketing of cannabis products for medicinal purposes. So far, there are eight cannabis products approved by ANVISA.
Brazil’s Anvisa identifies positive Covid-19 case in Brazilian passenger from South Africa
The Ordinance No.660/2021 It would impose restrictions on exceptional and specific restrictions, measures and requirements for entry into the country, due to the risks of contamination and dissemination of the SARS-CoV-2 coronavirus (covid-19).