Recently, the Drug Evaluation Center of the National Medical Products Administration has successively released the "Technical Guidelines for Overfilling Research of Chemical Generic Drug Injections" and the "Technical Guidelines for Pharmaceutical Research of Chemical Generic Drug Oral Solutions". Both guiding principles have relevant requirements for packaging.
The Technical Guidelines for Overfilling Research of Chemical Generic Drug Injections clearly state that:
This guideline only applies to the marketing application and post marketing related change research of chemical generic drug injections packaged in ampoules and penicillin bottles (such as changes that may affect the filling volume, etc.), and does not apply to other packaging forms of injections (such as pre filled packaging systems, intravenous infusion bags, etc.).
The Technical Guidelines for Pharmaceutical Research of Generic Oral Solutions of Chemical Drugs require the following:
Packaging materials and measuring devices
（1） Packaging materials
The packaging materials for generic drugs are recommended to be consistent with the reference formulation. If there is inconsistency, sufficient evidence must be provided.
（2） Measuring device
Multi dose packaged oral solutions are usually equipped with measuring devices such as measuring cups, droppers, or syringes in the packaging. The measuring devices used should fully consider the convenience and safety of use. It is recommended to use the same device as the reference formulation for obtaining generic drug dosage.
The measuring device should indicate the liquid dosage unit (such as milliliters), and the scale unit should be consistent with the dosage unit in the instruction manual to prevent safety risks caused by incorrect measurement. The applicant should choose a reasonable dosage device based on the instructions, and the dosage of the dosage device should be as suitable as possible for all recommended doses, not significantly greater than the maximum dosage stated in the instructions, and should be able to accurately measure the minimum dosage stated in the instructions. The experiment should be designed reasonably according to the usage and dosage in the instructions, and the accuracy of the dosage of the measuring device should be studied.
（3） Compatibility Study
There is a risk of interaction between oral solution and packaging materials. Therefore, the applicant should conduct a study on the compatibility of packaging materials based on risk assessment, which includes factors such as prescription composition and packaging materials. For example, if the prescription contains alcohols or other co solvents, there is a high risk of interaction with plastic and elastomeric packaging materials, and compatibility studies should be conducted. The ideas and methods for compatibility research can refer to the Technical Guidelines for Compatibility Research of Chemical Drug Injections and Plastic Packaging Materials.
In addition, in terms of stability research, the guiding principle also proposes:
For oral solutions of water-based matrices packaged in semi permeable containers, stability testing should be conducted under low relative humidity conditions. In addition to routine testing indicators, the water loss rate should also be included, and the storage conditions should comply with the stability research guidelines. Oral solutions that may be unstable at low temperatures should undergo low-temperature testing or freeze-thaw testing.
Multi dose packaged oral solutions require stability study data during use. It is recommended to use samples with a near expiry date or samples from the last time point of the submitted stability study, combined with the instructions for usage and dosage, to simulate the actual drug use process for research. The changes in key indicators including physical and chemical properties, microbial limits, etc. should be examined, and the research results should support the stability of the product during use after opening.