China Pharmaceutical Packaging Registration

Background of Pharmaceutical Packaging Registration in China

The "Chinese Pharmacopoeia" stipulates that drug packaging materials refer to packaging materials and containers directly in contact with drugs produced by drug production enterprises and preparations prepared by medical institutions. In addition, pharmaceutical packaging materials that do not directly contact the drug but affect the drug also need to be registered and supervised as pharmaceutical packaging materials. Pharmaceutical packaging plays a vital role in ensuring drug safety, efficacy, and quality. In China, pharmaceutical packaging materials need to be registered with the National Medical Products Administration (NMPA) before being used in pharmaceutical packaging.

About Us

Our company provides pharmaceutical packaging registration services to help our clients navigate the complex regulatory landscape in China.

The registration process for pharmaceutical packaging materials in China is a rigorous and time-consuming process that requires careful planning, expert knowledge, and attention to detail. Companies seeking to register their packaging materials in China should work with a reputable regulatory affairs and compliance company, such as our company, to ensure a smooth and efficient registration process. Our team of experts has a thorough understanding of pharmaceutical regulations and the experience to provide solutions at all critical stages of the drug lifecycle. We provide guidance on regulatory requirements for pharmaceutical packaging materials and assist companies in completing registration. With our expertise, efficiency, and flexibility, we can help companies succeed in the Chinese market and ensure the safety and quality of their pharmaceutical packages.

Types of Pharmaceutical Packaging

We provide registration services for the following pharmaceutical packaging materials and containers. After receiving NMPA approval, these materials receive the "imported pharmaceutical packaging registration certificate" and can be exported to China.

• Infusion bottles (bags, film, and accessories)
• Ampoules
• Pharmaceutical stopper
• Pharmaceutical prefilled syringes
• Pharmaceutical (injection, oral, or topical dosage form) bottles (tube cap)
• Pharmaceutical eye drops (nose, ears) bottle (tube)
• Pharmaceutical aluminum foil
• Pharmaceutical hard pieces (film)
• Pharmaceutical ointment tube (box)
• Pharmaceutical spray (gas) aerosol pump (valves, tanks, cylinder)
• Pharmaceutical desiccant

Registration Types for Pharmaceutical Packaging Materials

Pharmaceutical packaging materials require different registration information depending on the use or risk of exposure to the drug. We provide our clients with various types of registration for pharmaceutical packaging materials and assist them in preparing their registration documents.

• Manufacturing application: Registration application for pharmaceutical packaging materials produced in China.
• Import application: Registration application for the marketing of pharmaceutical packaging materials produced overseas in China.
• Supplementary application: Registration application for changing, adding, or canceling the original approved items or contents after the production application and import application are approved.

Registration Steps for Pharmaceutical Packaging Materials

a) Fill in the basic information of the pharmaceutical packaging materials on the Drug Evaluation Center (CDE) portal website and submit the registration information to CDE.

b) CDE will review the completeness of the registration materials within 5 working days after receiving the materials.

c) When the information is incomplete, the pharmaceutical packaging material enterprise is required to supplement the registration information until it meets the requirements.

d) CDE will publicize the relevant registration information and grant the I status registration number.

e) When the pharmaceutical packaging material passes the associated review, the registration number will be activated as A status.

Our Pharmaceutical Packaging Registration Services

• Pharmaceutical packaging registration consultation
• Acting as local agent and representative for pharmaceutical packaging registration in China
• Translation of registration documents
• Support checklist and data gap analysis for feasibility assessment
• Customized risk assessment and optimization of registration strategy analysis
• Following up on the review of pharmaceutical packaging materials
• Annual report on pharmaceutical packaging materials
• Laboratory commissioning and test supervision
• Submission of renewal applications and providing updated information on packaging materials
• Official communication

If you need help or have a question, please feel free to contact us for more details.