The manufacturing process of fermented new drugs is complicated, and the quality control is difficult. Referring to the relevant technical guidances of new drug chemistry, manufacturing, and control research, centering on the quality control characteristics of fermented new drugs, this article discusses the general considerations on the manufacturing process, elucidation of structure, specification research, to provide a reference for the research of fermented new drugs.

Complex injections are usually a kind of modified new drugs with new dosage forms, formulations and manufacture processes. It is an effective method to reduce inherent deficiencies of active ingredients with advanced techniques. Complex injections can reduce side effects of drug substances, improve drug efficacy, promote patients' compliance and so on. In the increasingly competitive generic drug market, they have obvious clinical advantages and market competitiveness. However, complex injections usually own complicated formulations and processes. Based on guidances and policies at home and abroad, in this paper, we briefly discussed the CMC requirements for complex generic injections according to the characteristics of different complex injections.

Blood products are manufactured by separation of plasma from healthy donors, which have a wide range of indications and play a critical role in the prevention and treatment of certain major diseases. However, because of the uniqueness of their source, the viral safety of blood products is always highly concerned by various national regulatory authorities. This manuscript discussed viral safety-related issues of blood products in combination with technical review practice, from aspects like source plasma, virus removal/inactivation processes, regulation requirements and considerations in technical review, etc., in order to provide references for future research and development.

In this paper, the author investigated and compared the domestic and foreign laws and regulations and current pharmacopoeias of different countries related to the storage conditions of chemical drugs, then put forward some thoughts and suggestions in combination with the existing problems of the storage conditions of chemical drugs, so as to provide reference for the establishment and standardization of the storage conditions of chemical drugs.

The concept of analytical quality by design (AQbD) guides pharmaceutical industries in the development and maintenance of systematic analytical procedures using scientific knowledge and quality risk management approach. The quality control of biological products is the critical content of the pharmaceutical research and evaluation, and is important to ensure the safety, effectiveness and stability of products. The analytical procedures used for quality control contribute to the quality control system. Lifecycle management of analytical procedures includes analytical procedure development, validation, transfer, change and continual improvement. This article introduced the concept and application of lifecycle management of analytical procedures and regulatory considerations according to the quality control characteristics of biologics and the experience of drug evaluation.

In order to encourage clinical value-oriented drug innovation, the current "Drug Registration Regulation" proposes four expedited regulatory approval procedures. For innovative drugs with early clinical trial data that can likely predict the efficacy and clinical benefit of the drugs, the marketing authorization might be granted before the completion of the confirmatory clinical trial through the conditional approval procedure, with all data comprehensively reviewed. By implementing the procedure, patients with serious diseases or conditions can expect more opportunities to prolong their lives or improve their quality of life. Since conditional approval procedures can shorten the time for pre-market clinical research and development, its supporting policies and criteria have attracted much attention. This paper takes the innovative anti-tumor drugs as the starting point, systematically sorts out the policy requirements of conditional approval in China and the criteria that have been formed in the review process, and tries to analyze the problems encountered in the implementation of conditional approval and put forward solutions.

Clinical study for medicine products is a time-consuming and high-cost project. As a great tool of optimizing trial design, simulation technology plays an important role in different phases and different indications of clinical trials. At present, different regulatory agencies have established corresponding technical requirements for simulation technology. This paper summarized the development of the guidelines of NMPA, FDA, EMA, and ICH to elaborate the regulatory status of simulation technology. Without additional clinical trial data, one pharmaceutical company successfully expanded the indications of adalimumab in adults for hidradenitis suppurativa to adolescent by virtue of only model simulation results. This article analyzed this case in detail to illustrate the importance of simulation technology. Finally, this paper discussed the advantages and disadvantages of simulation technology, as well as the considerations in practical application.

For post-approval CMC Changes, ICH Q12 proposed management tools such as categorization of post-approval CMC changes, ECs, PACMP, and PLCM documents. The United States, the European Union and China have different approaches in implementing these management tools. It is of great significance to learn from and refer to the implementation experience of the United States and the European Union for optimizing China's post-approval CMC change management. We hope to change the supervision department's concept of post-approval CMC change management, manage changes by category, and optimize change management tools.

Taken literature in the field of pharmacovigilance risk management from 2002 to 2021 in the Web of Science Core Collection database as sample data, used Excel and Cite Space software to conduct bibliometric analysis on research trends, literature sources, research subjects and research hot spots of relevant literature, and to construct the knowledge map in the field of international pharmacovigilance risk management. Study shows that the field of international pharmacovigilance risk management presents obvious phase increasing characteristics overall. The research institutions are divided into four cooperative groups: the United States, France, the Netherlands, and Italy. There are three models of groups with close cooperative relationships: university-university, university-medical institution, and government agency-medical institution, and the cooperative relationship among institutions has been gradually strengthened. Research hot spots are focused on adverse drug reactions, signal detection, pharmacoepidemiology, etc. Drawing on the international research results, the development of pharmacovigilance risk management in China can be enlightened from their research subjects and research hot spots.

3CL protease inhibitors has become the focus of the current research on anti-coronavirus drugs. The analysis of the patent information will help the research and innovation of such anti-coronavirus drugs. This paper analyzes the application trends of anti-coronavirus 3CL protease inhibitor-related patents, the distribution of regional status of patents, important applicants, patented technology themes, progress of key drug development and other factors. We also analyze the development of related patent technologies and aim to help domestic pharmaceutical enterprises carry out innovation and complete the strategic layout.