With the development of nuclear medicine, nuclear technology and molecular biology, radioligand therapy has become an important development direction of precision medicine. In China, radioligand therapy drugs are usually called radionuclide drug conjugates (RDC). These drugs deliver radionuclides to specific tumor sites by coupling targeted ligand molecules to realize different functions of diagnosis or treatment. This article analyzes the research progress of RDC and the issues faced at the level of technical evaluation, and puts forward relevant reflections and research paths, aiming to provide reference for China's drug regulatory authorities to formulate corresponding policies and measures.

The taste of drugs can significantly affect the clinical application effect. The traditional evaluation methods for the taste of drugs include human mouth test, animal preference test, and in vitro analysis methods such as in vitro dissolution test. A new tool for drug taste evaluation, electronic tongue, was introduced in this paper. Electronic tongue is an in vitro bionics technology, which can output the taste of drugs with the overall taste information of samples. It has good objectivity and fast detection speed, and can avoid the potential safety risks and subjective factors in human mouth test. This paper introduces the development of electronic tongue and its application in drug taste evaluation, and puts forward some suggestions for further application and development of electronic tongue.

Following the announcement by China of the adoption of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) on “Continuous manufacturing of drug substances and drug products. Q13”, the implementation of this guidance has become a widespread concern in the pharmaceutical industry. The residence time distribution (RTD) and its mode serve as crucial tools outlined in the guidance designed for facilitating material traceability and support diversion strategies in continuous manufacturing. This article begins by introducing the concepts of residence time, RTD and its mode and then details the draft process of this guidance. The relevant sections on RTD are also summarized, aiming to enhance comprehension of the guidance and their associated requirements and thereby to aid in the successful implementation of continuous manufacturing technology in China.

Sponsor, drug clinical trial institution, regulation are all important for the quality management (QM) of drug clinical trials. Sponsor is ultimately responsible for the quality of drug clinical trial. Drug clinical trial institution is responsible for the operation management of drug clinical trial. Regulation is responsible for the supervision of drug clinical trials. Meanwhile, sponsor and drug clinical trial institution are also important evaluated objects for their QM. At present, the development of scientific methods for QM evaluation of drug clinical trial is attracting increasing interests. However, at present, the studies mainly focus on evaluating hardware construction levels other than managing abilities, partially due to the complexity of drug clinical trials. In this study, existing QM theories were summarized, the existing strategies were reviewed, and the evaluating challenges for QM were discussed. In the view of evidence-based decision-making, potential evaluation strategies were discussed based on the concept of quality management system in drug related fields.