Notice on the collection of National Standard Research Institutes for Metallic Pharmaceutical Packaging Materials

Publishdate:2022-10-09 Views:177

All relevant units:

In order to build a good national standard system for pharmaceutical packaging materials and promote the standard formulation model of "government-led, enterprise-dominated and social participation", research institutes are now invited for the General Rules and supporting general testing methods for metal pharmaceutical packaging materials in Chinese Pharmacopoeia (see Annex 1 for the list).

The units that intend to participate in the research task should fill in the "Chinese Pharmacopoeia" General Principles for Metallic Drug Packaging Materials and Supporting General Detection Methods Research Unit Declaration "(see Annex 2). After receiving the application, our committee will organize experts to review and determine the leading units and participating units of each project. Specific requirements are as follows:

一、Conditions of Applicant

1.The APPLICANT SHALL BE QUALIFIED AS AN INDEPENDENT LEGAL ENTITY OR a contracting entity, BE able to provide the necessary conditions FOR conducting the research, be responsible for the authenticity of the application materials, and be able to assume the corresponding management responsibilities.

2.The applicant shall have relevant scientific research and technical capabilities, and have professional and technical personnel who are familiar with relevant policies and regulations at home and abroad, technological development trends, and understand the existing problems and solutions.

3.Encourage marketing authorization holders (pharmaceutical manufacturing enterprises), pharmaceutical packaging materials manufacturing enterprises, inspection institutions, educational and scientific research institutions, and social organizations to actively apply.

4.The research expenses of our unit shall be self-funded.

二、Fill in and submit the declaration form

The declaration form should be printed on A4 paper with both sides, stamped with the official seal of the company as required, and mailed to the Pharmacopoeia Commission. Meanwhile, the electronic version of the declaration form should be sent to the email address of the contact person. The deadline for receipt of the declaration is 15 days from the date of this notice.

Mailing Address: Building 11, Fahua Nanli, Dongcheng District, Beijing (Postcode: 100061)

Addressee: National Pharmacopoeia Commission General Rules Excipient Packaging Materials Section

Contact person and Tel: Kang Xiaobo 010-67079620


The attachment:

1.Chinese Pharmacopoeia (Chinese Pharmacopoeia) List of General Rules and Supporting General Testing Methods for Metallic Drug Packaging Materials

2. Application Form for Research Institutions of General Rules and Supporting General Testing Methods for Metallic Drug Packaging Materials in Chinese Pharmacopoeia