Blog | Entry to Regulatory

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...

European Regulatory Hot Topics for Medicines

Introduction: The European Medicines Agency (EMA) is responsible for evaluating and approving medicinal products within the European...

Chinese medicines Regulation

The Chinese medicines regulatory landscape is unique and complex. The regulatory process for medicines in China is overseen by the...

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...

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...

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...

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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