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Category: Pharmaceuticals and Biologics

China’s NMPA issues Notice on Technical Guidelines for Change Studies of Marketed Chemical Drugs

On November 8, 2022, the CDE issued a notice on “Questions and Answers for Dissolution Profile Studies ⟨Technical Guidelines for Pharmaceutical Change Studies of Marketed Chemical Drugs (Trial) ⟩”

China’s NMPA Announces Electronic versions of Drug & API Export Certificates are now available (2022)

On December 2022, a new template Drug Export Sales Certificate has been launched, which conforms to the format recommended by the World Health Organization (WHO). Electronic certificates have the same effect as paper certificates.

US-FDA Publishes New Requirements for OTC Drugs Labeling

On September 8,2022, FDA published the draft of a guideline that provides recommendations on the labeling of OTC drugs.

FDA publishes product-specific guidances to facilitate generic drug development

FDA publishes product-specific guidance’s to facilitate generic drug development.

Overview of generic drug registration with USFDA

Drug companies must submit an abbreviated new drug application (ANDA) to FDA for approval to market a generic drug.

THE US-FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain

FDA published FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain.

THE US-FDA publishes product-specific guidances (PSGs) to facilitate generic drug development

On May 2022, the FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, helping to streamline generic product

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.

The USA FDA updated Electric CPP’s with quick response QR code

Beginning on March 25, 2022, the FDA will be adding a unique quick response (QR) code to electronic Certificates of Pharmaceutical Products (eCPPs)

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 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.

Brazil’s Anvisa Updates the List of Brazilian Common Appellations

The Brazilian Health Regulatory Agency (ANVISA) issued the regulation RDC No. 752/2022 .

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.

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