Medical Policies Weekly

1. CDE issued a number of drafts for comments

(1) "Technical Guidelines for Writing Safety Reference Information in the Investigator's Handbook (Draft for Comment)" and "Examples of Safety Reference Information (Draft for Comment)", including overview, content, form of expression, version, revision, quality management system and refer to the chapter of adverse reaction situations in the label of marketed drugs, and put forward an example of writing safety reference information for assessing the expectation of serious adverse reactions. It is suitable for the writing of safety reference information in the researcher's manual approved to conduct clinical trials of drugs (including traditional Chinese medicine, chemical drugs and biological products).

(2) "Guidelines for Clinical Research Design of New Drugs for Advanced Colorectal Cancer (Draft for Comment)", including background, detection of biomarkers in colorectal cancer, exploratory trial design, key registration trial design and conclusion, applicable to support clinical trial design and end point selection for advanced colorectal cancer indication registration.

(3) "Technical Guidelines for Pharmacokinetic Research in Patients with Renal Insufficiency (Draft for Comment)", which mainly includes the introduction, basic considerations, research design, data analysis, required application, instruction and appendix for pharmacokinetic studies in patients with renal insufficiency, and are applicable to the pharmacokinetic study of patients with renal insufficiency in clinical trials of new drugs.

(4) "Technical Guidelines for Clinical Pharmacology Research of Biosimilar Drugs (Draft for Comment)", which includes overview, clinical pharmacology research purpose, research content (including pharmacokinetic and pharmacodynamic research content, safety and immunogenicity considerations), application requirements and reference documents and are intended to provide technical references for the research and development of biosimilar drugs.

2. CDE issued the "Notice on Regulating the Applicant's Information Remarks for Children’s drug"

On July 9th, CDE issued the "Notice on Regulating the Applicant's Information Remarks for Children’s drug ", which will come into force on the date of issuance of the notice. The notification requirements are as follows:

When submitting clinical trial applications and marketing applications, the applicant should note under the "Other Matters" entry in the drug registration application form (multiple notes can be noted): apply for child-specific drugs, apply for new children's applications (indications, usage and dosage), this product belongs to encourage the research and development of the list of children's drugs (indicate the batch and number).

When submitting a supplementary application, the applicant shall note under the item of "Supplementary Application Content" in the drug registration application form (multiple notes may be noted): apply for new children's application (indications, usage and dosage), apply for revision of children's application (indications, usage and dosage), apply for the addition of special specifications for children, apply for revision of children’s application information in the instructions, and apply for other matters related to children’s applications.