01 August 2016

Highlights on the draft rules of drug registration

On July 25, 2016, the China Food and Drug Administration (“CFDA”) published the Administrative Provisions for Drug Registration (Revision) (the “Draft for Comment”) and submitted the Draft for Comment for public opinions.  Composing of 8 chapters and 147 provisions in total, the Draft for Comment differs in length and structure from the current Administrative Provisions for Drug Registration (the “Current Provisions”) published in 2007.  Highly instructive, the Draft for Comment reflects a series of fundamental reforms in medical industry since 2015.

i. Drug registration focuses on drug marketing authorization holder mechanism 

China has implemented the registration mechanism that ties the drug manufacturing license with the drug approval number for a long time.  On August 18, 2015, the State Council published the Opinions on Reforming Drug and Medical Devices Review and Approval Mechanism (Guo Fa [2016] No. 44, the “No. 44 Opinions”) and proposed the pilot drug marketing authorization holder mechanism (“Drug MAH Mechanism”).  On June 6, 2016, the General Office of the State Council officially released the Pilot Plan for the Drug Marketing Authorization Holder Mechanism (“Pilot Plan”), and ten provinces and cities, including Beijing, Tianjin and Shanghai, will implement the pilot Drug MAH Mechanism.

The Draft for Comment redefines the drug marketing authorization applicant as a “domestic entity” instead of a “domestic institution”, which is coherent with the Pilot Plan which allows the drug research and development (“R&D”) institutions and researchers to be drug registration applicants and drug marketing authorization holders.  Besides, according to the Current Provisions, the CFDA Certification Committee for Drugs has to inspect the manufacturing site before granting an approval.  In the Draft for Comment however, the manufacturing site inspection and sampling is no longer a necessary step and the CFDA drug approval institution can decide whether or not to take such a step as it deems needed.

Moreover, the applicants now bear more responsibilities.  For example, the applicants shall take charge of the whole process of drug R&D and application, establish a corresponding quality management system of drug R&D and trial production, and ensure standardized and traceable drug R&D and trial production process, etc. 

ii. Increase approval efficiency and decrease backlogging of applications

The Draft for Comment optimizes the approval procedure of drug clinical trial and drug marketing authorization and requires that the review and approval decision in each stage shall be made within specified time limits.  For the applications that are denied, a Notice of Approval Opinions shall be issued with reasons, which can ensure the approval efficiency and transparency to a large extent. 

The Draft for Comment also establishes the related review and priority review mechanism mentioned in the earlier reform to increase approval efficiency and decrease backlogging of applications.  Marketing application for raw medicine and preparation or supplementary application for preparation already launched in the market will be submitted for a related review and approval, and drug, drug packaging material and drug excipient will be submitted for a related approval. 

iii. Emphasis on clinical value and drug innovation

The general principle of the Draft for Comment is explicitly expressed, which is to “encourage clinical value oriented drug innovation”.  It has been made clear that new drugs should possess explicit clinical value and modified drugs should have evidence of clinical advantage over the originals, which will effectively prevent false innovation like remarketing after simple changes, and stimulate initiatives for drug innovation entities.

Furthermore, the CFDA sets up a priority review mechanism based on the clinical needs and drug features, which will shorten the approval time and increase the approval efficiency.

iv. Improve the drug clinical trial procedures 

Chapter 3 of the Draft for Comment, with 37 articles divided into 4 sections, stipulates in details on the review and approval, subsequent review, record-filing administration and risk control of drug clinical trial applications, which heightens the responsibility of applicants, clinical trial institutions and ethics committees regarding risk control and trial subjects protection.

The Draft for Comment adopts a flexible management of drug clinical trials. Applicants can conduct Phase I, II, III in order or concurrently, or conduct corresponding clinical trials based on the data which has already been obtained.

v. Quality and efficacy conformity assessment of generic drugs

The General Office of the State Council published the Opinion on Conducting the Consistency Evaluation for the Quality and Curative Effect of Generic Drugs in February 2016, which further specifies the promotion of the consistency in evaluation for the quality of generic drugs mentioned in the No. 44 Opinions.  The Draft for Comment removed the chapter of “Application and Approval of Generic Drugs” in the Current Provisions.  The stipulation on the marketing of generic drugs reflects in the chapter of “Marketing Authorization of Drugs” in the Draft for Comment, and no longer applies to specific regulations in the Current Provisions.

vi. Record filing Management of Bioequivalence Experiments

The CFDA published the Announcement on Implementing Record Filing Administration on the Bioequivalence Experiments of Chemical Drugs on December 2, 2015, to shorten the time of obtaining the permit for conducting bioequivalence experiments (“BE”) of chemical drugs and to improve the efficiency and quality of drug evaluation.  The announcement requires that from December 1, 2015, BE will be administrated through record-filing, instead of the review and approval process.  The Draft for Comment also stipulates that the BE applicants only need to file record on the Clinical Trial Management Public Platform and can start working after obtaining the filing number.  The filing information shall be announced to the public by the drug review institutions.

vii. Change of Authority for Approval and Regulation

The Draft for Comment adjusts the authority of the CFDA and the local FDA for the approval and regulation of drug registration.  It states that all the approvals of clinical drug trials and drug marketing shall be submitted to the CFDA, materials about follow-up clinical trial plans and other significant changes shall be reviewed by the CFDA and filing of non-significant changes in BE and clinical trials shall all be submitted to the CFDA.  The provincial FDA is responsible for the regulation of drug registration within its administrative region, and other drug registration issues entrusted by the CFDA.

In addition to the important changes above and in accordance with the spirit of No.44 Opinions, the Draft for Comment also has other highlights, such as building a communication system, expert consultation mechanism and dispute resolution mechanism, implementing the original number management, emphasizing the information disclosure responsibilities of the government in the review and approval process and the annual report responsibilities of the applicants.  As the most significant Draft for Comment to the Current Provisions in the past 10 years, the Draft for Comment undoubtedly needs continual attention and further interpretation.

Editor’s note: This article was simultaneously published on Chinalawinsight.com

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