IntroductionRegulated industries, including pharmaceuticals, medical devices, veterinary medicine, and cosmetics, are operated by regulatory affairs professionals. The regulatory affairs profession fo...
We were honored to participate in the 2025 China (Suzhou) Innovative Pharmaceutical Medical Conference and CMAC Annual Meeting, held from March 18-20. The event, under the theme "Harnessing New M...
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.
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