Introduction: Following the new Version of Measures for the Administration of Drug Registration, the new re-registration procedures for drugs manufactured overseas have been more detailed. This revision clearly stipulates that no supplementary application can be filed during the re-registration period, and clarifies the authority of supplementary application and re-registration.

On September 15, the Center for Drug Evaluation of The National Medical Products  Administration officially released the Re-registration Procedure, Application Material Requirements and Formal Review Contents for Overseas Produced Drugs (No. 26, 2020), providing policy basis for the re-registration procedure, application material requirements and formal review contents for overseas produces drugs.

The new re-registration procedures for drugs manufactured overseas is improving.

China’s drug re-registration work began in 2002 with the promulgation of the Measures for the Administration of Drug Registration, which first put forward the concept of drug re-registration: it refers to the approval process for drugs that continue to be produced or imported after the expiry of the validity of drug approval documents. The chapter 9 of the Measures were amended in 2007, which clearly stipulates the regulatory requirements for drug re-registration from Article 120 to Article 127.

However, there has been no detailed work management standard for drug re-registration to guide the specific work of drug re-registration for domestic and overseas products. Until November 2017, the former National Medical Products Administration issued the Notice of the General Administration on The Issuance of Guidelines for Acceptance and Evaluation of Drug Registration (Trial), in which the Guidelines for Acceptance and Evaluation of Re-Registration of Imported Drugs (Trial) further clarified the key points for acceptance and evaluation of re-registration of overseas produces drugs.

The new Version of Measures for the Administration of Drug Registration, which was officially released on March 30, 2020, is a historical node and provides framework provisions for the re-registration of drugs produced abroad. The supporting operation document was released in time for comments on April 30, and the official document was released on September 15.

Equip with new Measures for the Administration of Drug Registration

Undertaking the new version of the “Administrative Measures for Drug Registration”, the new re-registration procedures for overseas manufactured drugs have been more detailed. For example, the application for re-registration shall be submitted to the Center for Drug Evaluation six months before the expiry of the validity period, and the approval time limit shall be 120 days (the technical evaluation time limit shall be 100 days, and the administrative approval 20 days).In the review process, the re-registration and deregistration will be connected. If the re-registration is not approved, the drug registration certificate must be cancelled by the National Bureau.

Compared with the draft issued on April 30, the new overseas-produced drug re-registration procedure separates preparations and APIs in the “application information requirements” and “formal review”, and clearly stipulates that APIs need to be re-registered. And in the third part “formal review”, there are more detailed process and template requirement.

Rationalize the responsibilities and authority for re-registration and supplementary applications

The procedure for re-registration of oversea produced drugs is stipulated in Article 3, “In principle, the application for re-registration of drugs produced abroad cannot be applied for other supplementary application items at the same time. If the application is needed, it can be applied separately, and the evaluation can be conducted in conjunction with or separately according to the need.”

In the original Guideline for Acceptance and Evaluation of Re-Registration of Imported Drugs (Trial) issued in 2017, supplementary application items can be applied for at the same time when re-registering. However, the supplementary application for changing the place of origin or adding the drug specifications should not be filed at the same time. The application for changing the place of origin or adding the drug specifications should be filed separately according to the procedures of the supplementary application.

This amendment clearly stipulates that supplementary application cannot be filed during the re-registration period, and authority of supplementary application and re-registration.

The re-registration of drugs focuses on the re-evaluation of the quality, safety and effectiveness of the varieties within the 5-year production cycle. The information provided by the applicant should be the content that has been recorded or approved. The applicant cannot legalize the changes of prescription process through the re-registration.

According to the Measures for the Administration of Drug Registration, supplementary applications can be filed under two situations: 1).drug clinical trial applications and supplementary applications during drug clinical trials; 2).supplementary applications for approval changes, including supplementary applications during registration and Supplementary application for changes after listing.

Summary of policy documents related to drug registration

After the official release of the new version of the “Measures for the Administration of Drug Registration” on March 30, the National Medical Products Administration and the Center for Drug Evaluation have successively issued several drafts related to drug registration, technical guidelines for trial or formal implementation, and administrative procedures documents, which reflects the integrity and connectivity of the “Measures for the Administration Registration” and supporting documents.

Resources:

1.Measures for the Administration of Drug Registration.Learning and Practice |Comparison of the regulatory requirements for re-registration of overseas produces drugs in the new and old drug registration regulatory environment, iKang Weijian.

2.Announcement of the Center for Drug Evaluation of the National Medical Products Administration on the “Re-registration Application Procedures, Application Document Requirements and Formal Review Contents of Overseas Produced Drugs” (No. 26 of 2020)

3.Websites of National Medical Products Administration and the Center for Drug Evaluation.

4.Thoughts and Suggestions on drug re-registration.[J].China pharmaceutical affairs,2017,31(07):722-726. Zhong Demiao, Tang Jianyuan.