MEXICO’S COFEPRIS ANNOUNCES THAT THE INTERNAL AFFAIRS OFFICE WILL BEGIN OPERATION TO COMBAT CORRUPTION
On February 27, 2022, Cofepris, Mexico Health Authority, announced that the internal affairs office will start is operations in combating corruption.
REGISTRATION OF DRUG MASTER FILE (DMF) IN JAPAN
In Japan, the Drug Master File (DMF) is called “Master File” or “MF”. The Purpose of DMF is to protect the “know-how” of API manufacturing methods against the marketing authorization applicant (MAA) / holder (MAH) of pharmaceutical products. The foreign manufacturers of APIs can apply for DMF registration.
US-FDA Formal Meetings with OTC Sponsors
Overview: On February 1st, 2022, the US Food and Drug Administration (FDA) issued a draft of guidance on formal meetings between sponsors of over-the counter (OTC) monograph drugs and the agency.The guidance clarifies how sponsors can obtain advice on studies to support their submissions. It also addresses meeting types, meeting formats, content of meeting requests […]
Brazil’s Anvisa approves Anvisa regulates the use of self-tests for Covid-19
Brazil’s Anvisa approves resolution establishing requirements for registration, distribution, commercialization, and use of covid-19 self-tests.
Brazil’s Anvisa approves Rules for travelers entering Brazil
Foreign and Brazilian travelers abroad must present the Negative PCR exam to the airline company responsible for the flight, before boarding
Brazil’s Anvisa approves extending the use of CoronaVac to children and adolescents aged 6 to 17 years
The emergency use authorization granted this Thursday (01/20) is valid only for the age group 6 to 17 years old.
US-FDA TRANSITION PLAN FOR MEDICAL DEVICE UNDER EUA IN USA
On December 31st, 2021, the US Food and Drug Administration (FDA) published the draft of new guidance that outlines the transition plan for devices granted and marketed in USA under EUA designation during the coronavirus pandemic.
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).