New Pharmaceutical Packaging Regulations Released: Functionality, Convenience, and Economy

Policy Background: From Addressing "Excessive Packaging" to Full Lifecycle Management of Drugs
In recent years, the country has issued a number of policy documents addressing excessive packaging of goods. The 2024 "Key Points on Further Strengthening the Management of Excessive Packaging of Goods" explicitly includes pharmaceuticals as a key area of ​​regulation, requiring the reduction of packaging waste at the source. This draft for public comment was developed within this context, spearheaded by the Second Department of Clinical Chemical Medicines and collaboratively developed across multiple departments. During the drafting process, the CDE solicited feedback from the China Association for the Promotion of Pharmaceutical Innovation, the Drug Research and Development Committee of the China Association of Enterprises with Foreign Investment (RDPAC), and 10 domestic and international companies, collecting 62 comments. Suggestions such as "clarifying the basic considerations for appropriate packaging specifications," "designing specifications based on disease characteristics," and "advising large packaging for medications in medical institutions" were adopted. After internal review, workshops, and multiple rounds of revisions, the current version released to the public was finalized.

I. Overall Requirements: Equally Prioritizing Functionality, Convenience, and Economy
The draft for public comment clarifies that pharmaceutical packaging specifications must meet three core objectives: Functionality: ensuring stable drug quality and safety, with the specification design matching the drug's indication, physical and chemical properties, dosage form characteristics, and usage scenarios; Convenience: balancing the user experience for both patients and medical staff, reducing medication frequency and handling steps; Economy: avoiding unnecessarily complex packaging to minimize resource waste and environmental pollution. Companies should complete specification design during the R&D phase. Any adjustments required after market launch should be reported in accordance with the "Administrative Measures for Post-Marketing Changes to Drugs (Trial)."

II. Functional Design: Matching Disease Characteristics and Treatment Duration
The document states that for acute illnesses with short treatment durations, packaging should precisely match the dosage to minimize unused medication. For chronic illnesses with long treatment durations, larger packaging should be used to meet these requirements and reduce the number of doctor visits. For example, an oral originator drug for postherpetic neuralgia is packaged in 500ml bottles, providing a one-month supply, which not only accommodates the duration of pain but also enhances convenience. For medications taken daily, each box can be designed to provide at least two weeks' supply, with appropriate packaging based on the number of daily doses, dosage adjustment space, and dosage form volume.

III. Convenience Design: Reducing Duplication and the Risk of Errors

For outpatients self-administering medications, while ensuring medication safety, unnecessary follow-up visits and medication pickups should be reduced. For inpatient medications, large packaging with simplified minimum units is encouraged to reduce the workload of medical staff in splitting medications. Furthermore, key information such as the production date and expiration date must be clearly readable and prominently displayed, and background contrast should be used to enhance legibility to prevent medication errors.

IV. Economical Design: Cost Control and Environmental Protection

While meeting functional and convenient requirements, packaging design should be simple and practical, avoiding cost increases and resource waste caused by multiple layers, excessive gaps, or luxurious materials. This not only helps reduce production and distribution costs for businesses but also aligns with green development goals and medical insurance cost control requirements. V. Impact on the Industrial Chain: Collaborative Advancement Across the Upstream and Downstream
The guidelines set clear requirements for the pharmaceutical industry chain: upstream packaging material companies must provide materials that meet the physical and chemical properties, stability, and safety requirements of pharmaceuticals; midstream pharmaceutical companies must complete scientific and sustainable specification design during the registration phase to reduce frequent post-market adjustments; and downstream medical institutions and patients can achieve greater medication convenience and resource efficiency through appropriate packaging. Furthermore, the document forms a closed-loop policy framework with regulations such as the Drug Administration Law, the Drug Registration Management Measures, and the Regulations on Drug Inserts and Labeling. It also closely aligns with medical insurance policies and the requirements of the National Health Commission, promoting the institutionalization, standardization, and greening of drug packaging specification management.