How to make Hand-Sanitizer: WHO and FDA recommendations
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Regulatory Challenges faced by Cosmetic Companies
Cosmetics is a dynamic industry, with new novel products ready to market it puts significant pressure on companies to understand global regulation and registration processes in order to reach consumers and markets globally.
The FDA publishes Guidance for Nutrition and Supplements Facts Labels for Small Entity Compliance
FDA publishes guidance for final rule intended to help small entities comply with the nutrition facts labeling requirements
The FDA publishes FY 2019 GDUFA Science and Research Report
The FDA’s FY 2019 GDUFA report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts.
Anvisa’s Call Notice 2/2020 : Similar Drug Notice
On Thursday (1/30), Anvisa published Call Notice 2/2020 , aimed at requesting information on similar drugs registered in Brazil.
Accelerated Approval of Detection Reagents of Coronavirus in China
The Emergency Approval of Novel Coronavirus Nucleic Acid Detection Reagent has shown the NMPA accelerated approval of seven NAD Reagents in only four days before going to the market.
NMPA PUBLISHES NEW GUIDELINE ON HOW TO ADDRESS LETTER OF DEFICIENCIES FOR MEDICAL DEVICE COMPANIES IN CHINA
On January 16, 2020 the NMPA publishes guideline explaining how medical device manufacturers should respond to a letter of deficiency from NPMA.
ONE-TIME IMPORT OF BIOLOGICAL PRODUCTS FOR CLINICAL TRIALS IN CHINA
CDE releases No. 94 of 2018 stating that certain biological products maybe imported for a one- time for clinical trial purposes.
Changing of API registration in China NMPA- What you need to know
On January 17, 2020 The Center of Drug Evaluation has published a Notice on improving the relevant functions of the API registration system,