Medical Policies Weekly (Issue 26,2020)
1、The CDE issued Announcement of Guidelines on Data Monitoring Committee of Clinical Trials for Drugs (Trial) (No. 27 of 2020).
To guide the sponsors to establish a DMC of clinical trials for drugs, standardize the monitoring activities of a DMC, and promote protection of subjects' rights and interests and reliability of clinical trials, on September 23rd, the CDE issued Announcement of Guidelines on Data Monitoring Committee of Clinical Trials for Drugs (Trial) (No. 27 of 2020) and was implemented as of the promulgation date. The guidelines mainly describe the responsibilities, missions and composition of Data Monitoring Committee (DMC) in clinical trials and operational specifications and statistical considerations during DMC operation, and emphasize the independence of DMC and the principles to avoid conflicts of interests, aiming to providing the sponsors with instructional advice on the establishment and implementation of DMC with the guarantee of standard operation and smooth implementation of DMC. The guidelines are mainly applicable to critical clinical trials with the purpose of supporting drug registration and marketing and can be referred to in clinical trials for non-registration purposes.
2、The CDE issued Technical Requirements for Pharmaceutical Research and Evaluation of Chemical Medicines Marketed Overseas but Not Listed Domestically (Draft for Comments).
On September 21st, the CDE issued Technical Requirements for Pharmaceutical Research and Evaluation of Chemical Medicines Marketed Overseas butNot Listed Domestically (Draft for Comments) and solicited public opinions. The technical guidelines are divided into six parts: the first part briefly introduces the background of drafting for technical requirements, which will be used as the supporting documents of the new version of the Administrative Measures for Drug Registration (Administrative Order NO. 27); the second part clarifies the applicable scope of technical requirements, applicable to the original drugs that are listed abroad but are not listed in China imitated by domestic applicants, namely Chemical Medicines III and drugs listed abroad that apply for listing in China, namely Chemical Medicines Ⅴ(not applicable to Chemical Medicines 5.2 where the original drugs have been listed domestically); the third part briefly summarizes the basic considerations of the guidelines from such aspects as reporting requirements, pharmaceutical research, overall requirements for evaluation, GMP compliance in manufacturing process, pharmaceutical lifecycle management (LCM) and other aspects; in the fourth part, according to the characteristics of Chemical Medicines III, the basic contents of pharmaceutical research and evaluation of Chemical Medicines III are described successively based on the two parts of bulk drugs and preparations; in the fifth part, according to the characteristics of Chemical Medicines Ⅴ, technical requirements for declared data and research evaluation of overseas listed drugs are mainly elaborated; in the sixth part, the references include open technical guidelines issued by ICH, NMPA, FDA, EMA and industry associations, etc.
3、The CDE again solicited public opinions on the relevant technical documents of pharmaceutical electronic Common Technical Document (eCTD).
To accelerate the construction of eCTD system, according to the latest requirements for Provisions for Drug Registration and M4 Module 1 Administrative Documents and Drug Information and other related supporting documents, the CDE revised and improved Application Guidelines for eCTD (Draft for Comments) and Technical Specifications for eCTD (Draft for Comments) and Verification Standards for eCTD (Draft for Comments) formed in the early stage, and solicited public opinions again. The main contents of this revision include a) to adjust the descriptions and proven standards of directory elements and leaf elements required by sequences in Application Guidelines for eCTD and Technical Specifications for eCTD and Verification Standards for eCTD and to omit information requirements for “the authenticity of the declared information”; b) to adjust the type of registration behavior. For clinical trial applications, “new indications” will be changed into “new indications and drug combination, “safety report” will be changed into “safety report during research and development”, and types of “pharmaceutical annual report” will be deleted; for new drug application(NDA), to add two types of registration activity, “filing” and “reporting”; for abbreviated new drug application (ANDA), three types of registered activities are to be added: “filing”, “reports” and “new indications”; c) to adjust the operating requirements for extension node of eCTD declaration data in Technical Specifications for eCTD, that is to say, for biological products, 3.2. Section R shall be subdivided to meet the requirements for submission of registration and declaration data. Meanwhile in Verification Standards for eCTD, a validation entry for the naming convention of the extension node title is to be added; d) the use of STF file labels, validation entries for database files and data description files for clinical trial database-related documents are to be increased.
