As a sensor of environment-cell interaction, aryl hydrocarbon receptor (AhR) plays an important role in maintaining barrier function, immune system and antioxidant process of the skin. AhR regulates the expression of many genes that are related to basic skin functions. It is expressed in all types of skin cells and involved in the progression of a variety of inflammatory skin diseases, including atopic dermatitis and psoriasis. Due to the complexity of the AhR protein structure, its crystal structure has not been successfully resolved until researchers obtained the crystal structure of indirubin binding to HSP90-XAP2-AhR complex recently. Clinical studies have shown that activation of the AhR pathway by ligands is of significance to the treatment of inflammatory skin diseases, as demonstrated by the clinical success of an AhR agonist, Benvitimod, for the treatment of psoriasis. This article presents a brief review on the role of AhR in inflammatory skin diseases and the current progress in drug development.

This study used "microneedles" as the keyword to search for relevant literature in CNKI and PubMed databases from 2017 to 2022. This article reviews the research progress of the carriers of microneedles based on structures, preparation methods, pharmacodynamics and clinical applications. A total of 1 040 valid kinds of literature were retrieved from the two databases. The structure of microneedles can be divided into solid microneedles, coated microneedles, dissolve microneedles, hydrogel microneedles, and hollow microneedles. The microneedles preparation methods involve microcasting, drawing lithography, and 3D printing methods. Some microneedle carrier pharmacodynamics studies include the treatment of skin, metabolic diseases, immune system diseases, and eye diseases. The microneedles' clinical application researches include vaccine, radiofrequency therapy and biological diagnosis. The main direction of future microneedle research is to develop a new transdermal microneedle drug delivery system, which is combined with the new pharmaceutical preparation technology. This study provides reference for further development of microneedle transdermal delivery formulations. The authors expect to provide a reference for the related research on microneedles.

In 2022, the heat index of the whole biomedical industry gradually declined, but the hot track such as gene therapy and cell therapy remains active. Source technology breakthroughs and multidisciplinary cross-integration innovation have accelerated the process of new drug development. There are a rich variety of new drugs approved in 2022, and some blockbuster new drugs and new technology therapies have brought new therapeutic hope for complex diseases. The Center for Drug Evaluation and Research (CDER) of the US FDA approved 37 innovative drugs in 2022, 25 of which were first approved worldwide. The European EMA approved 51 innovative medicines throughout the year, 8 of which were first approved worldwide. Japan's Pharmaceutical and Medical Device Agency (PMDA) approved 48 new drugs throughout the year, 12 of which were first approved in the world. The National Medical Products Administration (NMPA) of China approved 40 new drugs throughout the year, 11 of which were first approved worldwide. This paper summarized the new drugs approved for market in the US, EU, Japan and China in 2022, and provided an outlook on new drug development and biopharmaceutical development trends in 2023.

The novelty examination of pharmaceutical crystal patents often requires the use of legal presumption as a method of finding out the facts. The process is complex because it involves the allocation and transfer of the burden of proof, the refutation and overturn of the presumed facts, and the use of legal techniques in the investigation of technical facts. Through typical cases, this paper compares the differences among different examination procedures in the judgment of evidence that is sufficient to challenge the novelty of pharmaceutical crystals and shift the burden of proof, and explores the reasons for the differences from the perspectives of the uncertainty of crystal acquisition, the purpose and value of the setting of substantive examination and invalidation procedures, the legal status of patents (applications), the burden of proof and the standard of proof, and further analyze the impacts of the presumption methods of different examination procedures and the performance of the parties' request and rebuttal on the grant and stability of the pharmaceutical crystal patent.

Drug regulatory science is a cutting-edge task in the field of drug regulation that has received much attention from the international community in recent years. Currently, different countries and regions have different foundations for drug regulatory industries, are in different stages of development, and face different prominent issues. Therefore, the focus of drug regulatory science and the problems that need to be solved are also different. The origin of drug regulatory science suggests that we should deeply consider the emergence and development of drug regulatory science from the perspective of the arrival of a new era and the emergence of new forces. The definition and characteristics of drug regulatory science suggest that it is a practical science that solves prominent problems and directly serves regulatory decision-making, and future studies should focus on drug regulation rules, develop new regulatory tools, standards and methods, and cultivate new theories, regulations and mechanism.

Based on the new changes in the definition of falsified and substandard drugs and the new requirements for their identification in newly revised "Drug Administration Law" and "Interpretation for Handling the Criminal Cases Endangering Drug Safety", this paper discusses a new working mode for the detection of falsified and substandard drugs. In the new working model, the detection of falsified and substandard drugs can be classified into two kinds: to need and not to need the support of testing results. If testing is needed, three factors should be considered, i.e., the implementer of testing, testing capability, and presentation of testing result. The paper cited two typical examples taking place respectively in 2006 and 2015 to elaborate how testing result supported the detection of falsified and substandard drugs, one is about illegally adding diglycol in injection, another is about adulterated Ginkgo biloba leaves and their extracts. In order to improve the quality and efficiency of the detection of falsified and substandard drugs and optimize the utilization of drug testing resources, the testing of falsified and substandard drugs under the new requirements should be based on the needs of the identification, with the goal of supporting the drug regulatory department to issue the identification opinion about the falsified and substandard drugs. The model will change the traditional understanding on the role of drug testing results in supporting the confirmation of falsified and substandard drugs, to delink the connection between detection and testing, making the testing result not the precondition for the confirmation of falsified and substandard drugs. In order to implement the new work mode, drug regulatory authorities at prefecture level and above need to clarify the identification of whether inspection support is needed according to the laws, national and provincial drug inspection institutions need to establish a division of labor and cooperation mechanism that matches the regulatory functions, and drug testing institutions need to clarify the requirements for samples, standards for testing, and testing conclusion.

Oil APIs for injection extracted from animals and plants mainly used in fat emulsions. Based on the requirements of relevant regulations, guidelines, and review experience in recent years, this paper expounds some considerations on the study of oil APIs for injection extracted from animals and plants, including starting materials and process control, impurity control, validation of virus inactivation/removal process, quality research, etc, in order to provide some references for future research．

Objective: To conduct a research on the current difficulties in the design, evaluation, and implementation of clinical trials of pediatric Chinese medicine and build a list of questions for the development of the Expert Consensus on Issues Related to Clinical Trials of Pediatric Chinese Medicine. Methods: The parties involved in clinical trials of pediatric Chinese medicine were surveyed by online questionnaires to learn the difficulties in the design, evaluation, and implementation of clinical trials. Results: A total of 49 questionnaires were collected, and the experts believed that it was difficult to determine the indications, test purpose, diagnostic criteria, age range, control drugs, efficacy and safety evaluation in the design and evaluation stage of clinical trials of traditional Chinese medicine for children, and there was a lack of scientific basis for developing medication regimen. In the implementation phase, the start time of the trial should be specified, and further improvement should be made in the aspects of ethical review, subject recruitment, informed consent, compliance, and DMC setting. Conclusion: There were many difficulties in the design, evaluation, and implementation of current clinical trials of pediatric Chinese medicines, which should be improved from various aspects such as policy, awareness, and technology, thus to promote the research and development of pediatric proprietary Chinese medicines.