Regulatory Requirements Of The Pharmaceutical Industry Us, Eu, And Japan All Have Their Own Regulatory Control

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In order for biotechnology and pharmaceutical companies to market their biologics and drugs, companies must receive approval from their respective regulatory authority. The three global leaders in the pharmaceutical industry US, EU, and Japan all have their own regulatory authorities. Each have their advantages and disadvantages and as a regulatory representative. Though there is a push to harmonize regulatory requirements at a global scale for the past 20 years development and approval of global guidelines has had drawbacks in approving drugs at a globally. The high regulatory uncertainty is considered as a major barrier for efficient development of safe and effective biological therapies, hence deterring entry for large multinational pharmaceutical companies to develop innovative biological products at a global level.1 For a biotechnology company it can be difficult to chose which market to seek the regulatory approval for first and many questions come to mind for which country will be beneficial for market approval. Personally as a regulatory affairs professional I would seek approval in the US due to the comprehensive history and development of the food and drug administration and the acceptance of the regulatory pathway at a global scale. Also the EU and US regulatory systems are more similar than different, and due to recent steps in harmonization from both regulatory regimes in scientific testing standards and clinical trials, it can make it more efficient to

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