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FDA Compliance Insights
This page includes our articles on regulatory requirements issued by different FDA authorities, including the US, Thailand, Saudi Arabia, Taiwan, and Philippines. The content covers registration processes, compliance expectations, and notable regulatory updates across regulated product categories.
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Cosmetics Insights Cosmetics Regulations & Registration Process in
When a product is classified as a medicine or a borderline product, it becomes a hurdle to enter South Africa's...
Cosmetics Insights Cosmetics Regulations & Registration Process in
Cosmetic notification in the Philippines is frequently delayed because the labels are non-compliant with the regulations, the claims made are...
Cosmetics Insights Cosmetics Regulations & Registration Process in
The Vietnam cosmetic launch may be postponed due to minor problems. This may be because the Certificate of Free Sale...
Cosmetics InsightsRegulations Cosmetics Regulations & Registration Process in
Anyone planning to put cosmetics on the EU market must notify the products in accordance with Regulation (EC) No 1223/2009....
MedTech InsightsRegulatory Updates Thai FDA Updates Medical Device Advertising
The Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License...
MedTech InsightsThai FDA Compliance Thailand Medical Device Import License Regulations
If you're looking to import medical equipment into Thailand, you'll need to get a Thai FDA license first. There’s paperwork, licenses,...
Nutraceuticals InsightsThai FDA Compliance Nutraceutical Regulations & Registration Process in
Thailand, known for its rich cultural heritage and breathtaking landscapes, is also a significant player in the global nutraceutical industry....
Nutraceuticals InsightsThai FDA Compliance Thai FDA Regulations of Food Manufactured
Thailand’s Ministry of Public Health and the Thai FDA handle most of the food regulation work. They keep an eye...
BiologicsUS FDA Compliance Biologics and Biosimilars Regulations, Registration Process
The size of the U.S. biosimilars market, estimated at USD 6.73 billion in 2021, is expected to increase by USD...
US FDA Compliance Pharmacovigilance of Vaccines in the USA
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other...
US FDA Compliance US FDA Regulation of Nitrosamines In
Nitrosamines are a class of compounds known for their potent carcinogenic effects. Their discovery in pharmaceuticals has sparked significant concern...
Cosmetics InsightsUS FDA Compliance US FDA Modernization of Cosmetics Regulation
On 29 December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) became part of the Consolidated Appropriations Act,...