THE US-FDA TO MODERNIZE CDER’S EXPORT CERTIFICATE PROGRAM
On December 3, 2021, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) will begin issuing electronic Certificates of Pharmaceutical Product (eCPPs) and will no longer issue or mail paper CPPs.
Brazil Regulatry Breakdown: Food supplement or specific medicine?
The food supplement category was created in Brazil in 2018 to ensure the population’s access to safe and quality products. However, there is still confusion about the framing and registering the products in brazil ; is it a Food Supplement or is its a specific medicine?
Japan’s PMDA implements Surprise GMP inspections at manufacturing facilities
On July 2021, Regulators in Japan announced they will start conducting inspections by surprise at facilities where drugs, pharmaceuticals and medical devices products are manufactured
Brazil’s Anvisa is accepted into International API Inspection Program
Anvisa is accepted as a member of the international API Inspection Programs.
An Introduction to Registration of Food Supplements in China
In China, nutrient supplements are regulated as one category under the umbrella term health food.
Brazil’s Anvisa releases a new Adverse Event Notification Form
Brazil’s Anvisa introduces new tool enables faster and easier notification of drugs and vaccines.