1. OverviewThe safety and effectiveness of pharmaceutical products are the main responsibilities of biopharmaceutical organizations and global health authorities. A strict regulatory review and approv...
BACKGROUNDIn the current scenario, regulations are becoming stricter in the pharmaceutical industry, and ensuring compliance with global regulatory standards is critical for the successful development...
BackgroundDifferent pharmaceutical agencies, like PMDA in Japan or EMA in Europe follow standard format of eCTD for submitting regulatory information to health authorities globally (Patil et al., 2024...
As China's National Medical Products Administration (NMPA) transitions to eCTD (electronic Common Technical Document) submissions, pharmaceutical companies face new challenges in adapting to these regulatory changes.
IntroductionThe Electronic Common Technical Document (eCTD) is the standard format for submitting health regulatory applications digitally. It is used globally by pharmaceutical, biotechnology, and me...
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