On January 7th, CDE issued 5 more clinically relevant guidelines, involving innovative drugs, improved new drugs, and traditional Chinese medicines. A total of nearly 20 were released this week!

Introduction: Today, CDE has issued 5 more guiding principles, including innovative drugs , improved new drugs , new traditional Chinese medicine drugs , and clinical and non-clinical related information.
See below for details
.

"Guidelines for random allocation of drug clinical trials (trial)", "Technical principles for human bioavailability and bioequivalence research of innovative drugs", "Technical principles for clinical pharmacokinetics research of modified-release modified new drugs", "Non-clinical drugs" Technical Guiding Principles for Dependence Research, "Technical Guiding Principles for Studying Samples for Toxicology Research of New Chinese Medicines (Trial)"

In order to clarify the relevant technical requirements for the design and implementation of random allocation in clinical trial research, the Center for Drug Evaluation organized the formulation of the "Guidelines for Random Allocation of Drug Clinical Trials (Trial)" (see attachment)
.

hereby notified
.

Annex: Guidelines for random allocation of drug clinical trials (trial)

Drug Evaluation Center of the State Food and Drug Administration

January 4, 2022

In order to further encourage and guide the scientific and rational development of human bioavailability and bioequivalence research during the clinical trials of innovative drugs and after they are put on the market, under the deployment of the State Drug Administration, the Center for Drug Evaluation organized and formulated the "Innovative Drug Human Technical Guidelines for Bioavailability and Bioequivalence Studies (see annex)
.

hereby notified
.

Annex: Technical Guidelines for Human Bioavailability and Bioequivalence Research of Innovative Drugs

Drug Evaluation Center of the State Food and Drug Administration

January 4, 2022

In order to further encourage and guide the reasonable and standardized pharmacokinetic research of modified-release preparations in improved new drugs and provide technical specifications for reference, the Center for Drug Evaluation organized the formulation of the "Technical Guidance for Clinical Pharmacokinetics Research of Modified-Release Preparations of Improved New Drugs".
Principles (see appendix)
.

In accordance with the requirements of the "Notice of the General Department of the State Food and Drug Administration on Issuing the Procedures for Issuing the Technical Guiding Principles for Drugs" (Yijian Zongyaoguan [2020] No.
9), and with the approval of the State Food and Drug Administration, it is hereby issued from the date of issuance to be implemented
.

hereby notified
.

Attachment: Technical Guiding Principles for Clinical Pharmacokinetic Research of Modified Release Preparations of Modified New Drugs

Drug Evaluation Center of the State Food and Drug Administration

January 4, 2022

In order to guide and standardize drug non-clinical dependence research, under the deployment of the State Drug Administration, the Center for Drug Evaluation organized the revision of the "Technical Guiding Principles of Drug Non-clinical Dependence Research"
.

hereby notified
.

Annex: Technical Guidelines for Drug Nonclinical Dependence Research

Drug Evaluation Center of the State Food and Drug Administration

January 4, 2022

Under the deployment of the State Drug Administration, the Center for Drug Evaluation organized the formulation of the "Technical Guidelines for the Study of Samples for Toxicology Research of New Chinese Medicines (for Trial Implementation)" (see attachment)
.

hereby notified
.

Appendix:

1.
Technical Guiding Principles of Sample Research for Toxicology Research of New Chinese Medicines (Trial)

2.
Drafting instructions for "Technical Guidelines for Research on Samples for Toxicology Research of New Chinese Medicines (Trial)"

Drug Evaluation Center of the State Food and Drug Administration

January 4, 2022

A total of 19 guiding principles/comments/notifications were issued this week, 14 have been issued before, see below
.

"Technical Guidelines for Clinical Research and Development of Rare Disease Drugs"

Guidelines for Clinical Trial Design of Drugs for the Prevention of Nausea and Vomiting Caused by Antineoplastic Drugs (Trial)

"Technical Guidelines for Pharmacokinetic Research in Patients with Renal Insufficiency (Trial)"

"Guidelines for Writing a Clinical Risk Management Plan (Trial)"

Publicly solicit opinions on the "Guidelines for Communication and Communication Technology Based on the "Three Combinations" Registration Review Evidence System

Notice on the application of E2B (R3) regional implementation guidelines for individual safety reports during drug clinical trials

"Technical guidelines for clinical trials of direct-acting antiviral drugs in chronic viral hepatitis C"

"Technical Guidelines for Clinical Trials of Ulcerative Colitis Drugs"

"Technical Guidelines for Clinical Trials of Drugs for the Treatment of Crohn's Disease"

"Technical Guidelines for Food Impact Research in New Drug Development"

Guidelines for Data Management and Statistical Analysis Plans for Drug Clinical Trials

"Guiding Principles for the Application of Patient-Reported Outcomes in Drug Clinical Development (Trial)"

"Technical Guiding Principles for Crystal Form Research of Chemical Generic Drugs (Trial)"

"Technical Guidelines for Writing Safety Reference Information in the Investigator's Handbook"