Medical Policies Weekly
1. CDE issued the "Common Pharmaceutical Issues and Related Technical Requirements of the Pre-marketing Application Meeting for Innovative Chemical Drugs"
In order to encourage the research and development and application of innovative drugs, improve the quality and efficiency of communication between applicants and regulatory agencies, and speed up the process of launching innovative drugs, CDE issued the " Common Pharmaceutical Issues and Related Technical Requirements of the Pre-marketing Application Meeting for Innovative Chemical Drugs " on November 26. It will come into force on the date of promulgation. The main content of the technical requirements includes the selection of starting materials for the synthesis of APIs, the research and control of API related substances, the research and control of the related substances of the APIs, the research on mutagenic impurities, the quality control projects of the APIs, the research on the formulation changes, and the formulations degradation impurities research, the research on formulation dissolution and release, the research on formulation quality control project, and other formulation-related issues, a total of 10 common issues and their general requirements.
2、CDE issued “Technical Requirements for Pharmaceutical Research of Inhaled liquid Formulations of Chemical Drugs”
In order to standardize and guide the pharmaceutical research of chemical inhaled liquid formulations, CDE issued “Technical Requirements for Pharmaceutical Research of Inhaled liquid Formulations of Chemical Drugs” on November 26, which will come into force as of the date of promulgation. The main contents of the technical requirements include preface, basic considerations, technical requirements for prescription process, atomization device, technical requirements for quality control of raw and auxiliary packaging, technical requirements for quality research and control, and stability research, which are applicable to the listing application of new chemical drugs (class 1 and class 2) and generic drugs (class 3 and class 4), for class 5.1 and 5.2 chemicals, the requirements for new drugs and generic drugs in this technical requirements can be referred to respectively. The application for clinical trial of new drugs can refer to the relevant research of the technical requirements.
3. CDE publicly solicits opinions on the "Guidlines for Evaluation of Immune-Related Adverse Events in Anti-tumor Therapy (Draft for Comments)"
On November 26, CDE issued the "Guidlines for Evaluation of Immune-Related Adverse Events in Anti-tumor Therapy (Draft for Comments)", and the time limit for soliciting comments is one month from the date of promulgation. The draft for comments mainly includes four parts: background, definitions and determination considerations, writing of safety information in the instructions, and summary. It aims to improve scientificity and robustness of the identification and determination of immune-related adverse events (irAE) in clinical trials of anti-tumor immunotherapy, improve the writing quality of clinical study report (CSR), summary of clinical safety (SCS), and adverse drug reaction (ADR) of the instructions, and strengthen the protection of subjects participating in the trial and the population of post-marketing medication patients.
