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Tag: Regulatory Affairs

Close up on vaccine and medical syringe
GxP

The Role of the EMA in Vaccine Approvals

In response to the COVID-19 pandemic, the European Medicines Agency (EMA) adapted its vaccine approval processes, implementing rolling reviews and enhancing collaboration with health authorities. This post analyzes the EMA’s pivotal role in granting conditional marketing authorizations for COVID-19 vaccines and discusses the implications for future vaccine regulation and public health strategies. Learn how transparency, accelerated approval processes, and increased patient engagement are shaping the future of vaccine delivery in Europe.

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MD/IVD Regulations

Medical Device Regulations Comparing Across the Continents

Though a leader in medical device regulation, Europe’s MDR presents a hurdle for global manufacturers. This excerpt compares it to the US FDA’s 510(k) pathway, highlighting stricter European requirements for data, documentation, and risk management. Understanding these variations is vital for international success.

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