According to the Chinese Pharmacopoeia, pharmaceutical packaging materials refer to the packaging materials and containers that come into direct contact with the drugs produced by pharmaceutical manufacturers and the preparations formulated by medical institutions. In addition, pharmaceutical packaging materials that do not directly contact the drug but have an effect on the drug (for example, aluminum-plastic packaging that does not directly contact the drug and has the effect of oxygen and water insulation) also need to be registered as pharmaceutical packaging materials.

Pairs of pharmaceutical packaging materials are usually divided into high-risk and non-high-risk two categories, of which high-risk pharmaceutical packaging materials generally include:

1, for inhalation preparations, injections, ophthalmic preparations of pharmaceutical packaging materials;

2, the State Drug Administration according to the monitoring data special requirements of the drug packaging materials;

The National Medical Products Administration (NMPA) belongs to the State Administration for Market Regulation, which is mainly responsible for:

Timely revise relevant inspection standards according to the situation and needs of provincial supervision and inspection;

Organize on-site inspection and inspection of raw materials, pharmaceutical excipients and pharmaceutical packaging materials as required.

The Center for Drug Evaluation (CDE) is part of the NMPA, which is responsible for:

Establish a registration platform and database for apis, pharmaceutical excipients and pharmaceutical packaging materials;

Receipt, integrity review, registration number grant and publication of registration data of apis, pharmaceutical excipients and pharmaceutical packaging materials, and review and approval of apis, pharmaceutical excipients and pharmaceutical packaging materials associated with pharmaceutical preparations.

1. Registration Form of Pharmaceutical Packaging Materials

2, the basic information of the registrant (name, address, production factory, production address, certification documents, research data storage address)

3. Basic information of pharmaceutical packaging materials (name of pharmaceutical packaging materials, packaging system/components, formula, basic characteristics, domestic and foreign approval and use information, national standards and domestic and foreign pharmacopoeia records)

4, production information (production process and process control, material control, key steps and semi-finished products, intermediate control, process verification and evaluation)

5, quality control (quality standard, analysis method verification, quality standard formulation basis)

6. Batch inspection report (Batch inspection project shall provide inspection report of not less than three batches of samples)

7, self-stability research (provide self-stability research data of pharmaceutical packaging materials)

8, compatibility and safety studies (compatibility studies, safety studies)

9, declaration

10, varieties and related conditions

11, product owner information

12, production enterprise information

13, commissioned research institution information

Announcement of the State Food and Drug Administration on Matters Related to Further Improving Drug Related Review, Approval and Supervision (No. 56 of 2019) According to the use of drug packaging materials are divided into the following categories:

1. Pharmaceutical packaging materials that have not been used in domestic and foreign listed drugs (such as new materials and new structures);

2. Package materials that have been used in domestic and foreign listed drugs, but have changed the drug administration route and increased the risk;

3, has not been used in domestic and foreign listed drugs, but can be proved to have been used in food packaging in direct contact with food packaging materials (only for oral preparations);

4. Pharmaceutical packaging materials that have been used in marketed drugs with the same route of administration;

5, other according to the use of the situation or the risk of exposure to the drug, the registration information provided is different. The general contents are as follows: