Navigating Combination Product Registration in China: A Comprehensive Guide

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Navigating Combination Product Registration in China: A Comprehensive Guide

Combination products, which are innovative therapeutic and diagnostic products that combine drugs, devices, and/or biological products, are becoming increasingly prevalent in the healthcare industry. In China, the registration of these products is governed by specific Regulatory frameworks that help ensure their safety, efficacy, and quality.

What is Taawon

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What is Taawon

The driving factors behind the medical device industry are still evolving, as the Gulf Cooperation Council (GCC)’s healthcare expenditure is rising dramatically. To maintain this trajectory, The GCC has developed a portal called Taawon to facilitate the registration and approval of drugs and medical devices in GCC countries.

EMA’s Accelerated Regulatory Mechanisms for COVID-19 Products

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EMA’s Accelerated Regulatory Mechanisms for COVID-19 Products

In the face of COVID-19 emergency, the European Medicines Agency (EMA) established faster scientific advice, rolling reviews and accelerated assessments to expedite the development and approval of medicinal products. EMA’s foresight is to support the development and marketing authorization of safe, effective and high-quality therapeutics and vaccines at the earliest.  As claimed, EMA adapts rapid procedures to significantly cut-short the Regulatory timelines for the review of new medicines and vaccines against COVID-19.