The National Medical Products Administration issued new Guiding Principles to strengthen regulatory oversight of pharmaceutical packaging and address concerns relating to excessive packaging. The guidance encourages applicants to determine appropriate packaging specifications at an early stage of pharmaceutical research, development, and registration. Packaging is expected to correspond to the medicinal product’s therapeutic indication, dosage form, stability profile, and intended clinical use.
The principles further introduce a proportionality-based approach, under which pack sizes should reflect the anticipated duration of treatment, taking into account the distinction between acute and chronic therapies in order to reduce waste and promote appropriate use. The guidance also highlights the importance of ensuring that packaging justifications are adequately documented within marketing authorisation dossiers and that manufacturers assess the potential regulatory implications of future post-authorisation variations in light of China's evolving pharmaceutical regulatory framework.