Key Points of Registration and Management of Pharmaceutical Excipients under the New Deal

Release time:

2020-06-16 11:32

Following the Announcement on Adjusting the Examination and Approval of Raw Materials, Pharmaceutical Excipients and Pharmaceutical Package Materials (No. 146, 2017) (hereinafter referred to as "No. 146") and the Announcement on Further Improving the Examination, Approval and Supervision of Drug Related Matters (No. 56, 2019) (hereinafter referred to as "No. 56"), on April 30, 2020, the State Drug Administration announced the Regulations on the Administration of Review and Approval of Chemical Raw Materials, Pharmaceutical Accessories and Pharmaceutical Packages and Pharmaceutical Preparations (Draft for Comments) (hereinafter referred to as the "Draft for Comments"), which has produced some changes in the management of pharmaceutical accessories in the draft for comments. Xinanrun Consulting summarizes the key points of registration and management of pharmaceutical excipients under the draft for comments for the reference of customers and friends.

1. registration scope

Article 29 of the draft for comments "pharmaceutical excipients and drug packaging materials (including packaging systems and functional accessories that do not directly contact with liquid medicine) used in applications for listing registration of various drugs and pharmaceutical excipients and drug packaging materials involved in changes in supplementary applications shall be registered on the registration platform, and relevant materials that meet the requirements may also be submitted together with the application for registration of pharmaceutical preparations".

That is, the registration of pharmaceutical excipients by non-compulsory production enterprises can be submitted at the time of application for registration of preparations.

Compared with the provisions of the current document No. 56 "for raw and auxiliary packages that cannot be registered on the platform due to special reasons, the applicant for registration of pharmaceutical preparations can also provide the research data of raw and auxiliary packages together with the application for registration of pharmaceutical preparations". the requirements for registration and operation of pharmaceutical excipients under the draft for comments are more flexible, giving enterprises more choice.

Article 30 of the draft for comments: "if the usage, dosage and function of pharmaceutical excipients and pharmaceutical packaging materials that have been used for a long time in food and drugs and have been recognized for safety fall within the scope of regular use, the data requirements can be simplified. the applicant for registration of pharmaceutical preparations shall list the product information in the preparation application materials and submit relevant materials that meet the requirements (see annex 1-4 for details). If the Center for Drug Evaluation deems it necessary during the review of the application for registration of pharmaceutical preparations, it may request the applicant for registration of pharmaceutical preparations to provide additional technical information. The list of such varieties shall be updated and published by the Drug Evaluation Center in due course."

That is, the current No. 56 under the 2.2-2.4 domestic and foreign pharmacopoeia has been included in the non-high-risk excipients, 3.1 and 3.2 enterprises to choose whether to register, in the preparation registration can simplify the registration data requirements of pharmaceutical excipients, further reduce the burden on enterprises.

2. registrant

§ Article 4 of the Exposure Draft "...... In principle, the registrant of the original and auxiliary packages shall be the original and auxiliary package production enterprise, and the overseas original and auxiliary package enterprise shall designate an enterprise legal person within China to handle the relevant registration matters......"

That is, when the domestic enterprise is registered, it acts directly as the registrant, and the foreign enterprise needs to designate the legal person of the enterprise in China as its agent. This item does not change significantly from the current 56.

3. registration management

Article 6 of the draft for soliciting opinions "if the same raw and auxiliary package products produced by the same enterprise at the same production site have the same production process and quality standards, they shall be registered in accordance with the same registration number". Please note that in the inquiry of auxiliary materials registration and filing

The same raw and auxiliary package products can only have the same registration number, and different registration numbers can exist for different quality standards.

4. Registrant Liability

§ Article 8 of the Exposure Draft, "The registrant of the original and auxiliary packages is responsible for maintaining the registration information of the registration platform and for the authenticity and completeness of the registration information. The overseas original and auxiliary package enterprises and the designated legal persons of enterprises in China are jointly responsible for the authenticity and completeness of the registration information"

That is, the responsibility for ensuring the authenticity and integrity of the registration materials falls on the registrant and/or agent, which is more targeted. This item is consistent with the current No. 56 document.

Management after 5. registration

Annual Report

Article 12 of the draft for comments "The original and auxiliary package manufacturer shall submit an annual report to the Drug Evaluation Center within three months after the original and auxiliary package has passed the technical review. The annual report should include product changes and related research information, and if there is no change, the relevant statement should be provided. The API shall indicate whether a change application has been made after the change and the relevant circumstances. Pharmaceutical excipients and pharmaceutical packaging materials shall provide relevant change research data and explain the use of all new authorized drug marketing license holders in the year (see Annex 1-2 for requirements). If the original and auxiliary package manufacturer fails to submit the annual report on time, the registration platform will no longer publicize the registration number."

This item designates the main body of the annual report as the production enterprise, and clearly proposes the corresponding punishment measures for not submitting the annual report on time, that is, the registration number will no longer be publicized. Compared with the current No. 56, the subject of the annual report is the registrant and there is no clear punishment, the enforceability is further.

Changes of Excipients for Traditional Chinese Medicine in Listed Preparations

Article 10 of the Exposure Draft "If the source of the raw and auxiliary packages of a pharmaceutical preparation already on the market is changed, the holder of the drug marketing authorization shall conduct research in accordance with the relevant guiding principles and other requirements, and declare in accordance with the relevant registration management regulations. If the raw and auxiliary packages to be used for the preparation fail to pass the associated review and approval, an application shall be submitted to the State Administration, and the identification of the raw and auxiliary packages shall be updated according to the results of the preparation shall be reviewed"

For the pharmaceutical excipients in the preparation that have not been approved by the association after the change, the "I" status of the pharmaceutical excipients shall be subject to the associated review and approval.

To sum up, some changes have been made in the management of pharmaceutical excipients under the draft for comments, mainly focusing on providing corresponding materials when enterprises can choose to register pharmaceutical excipients or review related to preparations. Non-high-risk pharmaceutical excipients included in domestic and foreign pharmacopoeias or pharmaceutical excipients that have been used for a long time and have safety in food and drugs are exempted from registration and the information required to be provided during the related review phase of preparations is simplified; A new definition of the liability of registrants, agents and/or production enterprises was introduced.

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