MedCity News February 5, 2025
It is imperative to understand the various regulatory variations globally, develop a strategy for new technologies, engage in harmonization activities, and implement risk management measures.
The biopharmaceutical industry faces strict regulations worldwide, making it essential to meet international standards before any new therapy can enter the market. Staying informed about the current and emerging trends in global regulatory management is a must to ensure the successful development and commercialization of biopharmaceutical products.
One of the biggest issues is the existence of different regulatory standards and expectations in various countries and international regions. Each regulatory authority has its own set of guidelines, submission formats, and approval processes. For example, the US Food and Drug Administration (FDA) and the European Medicines Agency...
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