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NMPA Guidelines

Meaning

The official regulatory directives and standards issued by the National Medical Products Administration (NMPA), the governmental agency in China responsible for the supervision of drugs, medical devices, and cosmetics. These guidelines establish the required criteria for clinical trials, manufacturing quality (GMP), product registration, and post-market surveillance for pharmaceutical and medical products entering the Chinese market. Adherence to NMPA guidelines is mandatory for ensuring the safety, efficacy, and quality of health products for consumers in China.
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What Are the Key Differences in NMPA Requirements for Chemically Synthesized versus Recombinant Peptides?

What Are the Key Differences in NMPA Requirements for Chemically Synthesized versus Recombinant Peptides?

NMPA requirements differentiate based on peptide origin, with chemically synthesized peptides emphasizing purity and recombinant peptides requiring extensive immunogenicity and host cell impurity characterization.



HRTio
August 25, 2025