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Entry to Regulatory
- Apr 12
- 3 min
US FDA Regulatory Hot Topics
As the regulatory agency responsible for ensuring the safety and efficacy of drugs, medical devices, and other products in the United...
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Entry to Regulatory
- Apr 12
- 4 min
European Regulatory Hot Topics for Medicines
Introduction: The European Medicines Agency (EMA) is responsible for evaluating and approving medicinal products within the European...
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Entry to Regulatory
- Apr 12
- 3 min
Chinese medicines Regulation
The Chinese medicines regulatory landscape is unique and complex. The regulatory process for medicines in China is overseen by the...
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Entry to Regulatory
- Apr 12
- 4 min
Nitrosamine Impurities in Medicines
Nitrosamine impurities have been a topic of concern in the pharmaceutical industry for some time now. These impurities can be found in a...
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Entry to Regulatory
- Apr 12
- 4 min
MHRA Clinical Trials Regulations: Largest Overhaul of Regulations in 20 years
MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years The Medicines and Healthcare products...
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Entry to Regulatory
- Apr 12
- 4 min
Titanium Dioxide Banned in EU: Impact on Medicines
The European Union (EU) has recently implemented a ban on the use of titanium dioxide as a food additive, citing potential health...
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Entry to Regulatory
- Apr 12
- 4 min
EU Clinical Trials Regulation (EU CTR)
The European Union (EU) has recently implemented a new regulation for clinical trials, which has been in effect since May 2019. The new...
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