Package integrity, which is synonymous with container-closure integrity, is the ability of a package to maintain product quality, including preventing microorganism ingress and ensuring that the product meets all necessary safety and quality requirement. Package integrity assessment begins at the product development phase and continues throughout the product life cycle, which is a key consideration in the manufacturing, quality research and evaluation of sterile products. This article mainly refers to the US Pharmacopeia (USP) 〈1207〉 guidelines, based on the understanding of CMC review experience, introduces and discusses the content of container-closure integrity, including concepts and scope, the requirements of different product life cycles, testing methods and validation, etc. It is hoped that the content of this article will provide some references for the quality study and evaluation of sterile pharmaceutical products.

This paper takes the guidelines on bioequivalence study in China as the main basis, refers to the relevant requirements of international regulatory agencies, and takes the cytotoxic and small molecule targeted oral antitumor drugs as examples to give some considerations for the study design of bioequivalence of oral antitumor generics from the perspectives of science, ethics and review.

Transthyretin amyloidosis (ATTR) disease is caused by abnormal folding of transthyretin (TTR) in tissues, which mainly involves the peripheral nervous system and heart, progressively aggravates to even be life-threatening. Currently, 3 TTR-targeted therapeutic drugs have been marketed in the United States and Europe. The information from these drugs' nonclinical pharmacology and toxicology studies has important implications for 3 clinical effectiveness and safety. This article summarized the key points of the nonclinical studies of these three TTR-targeted therapeutic drugs and elaborated the focus of nonclinical study and evaluation of TTR-targeted therapeutic drugs for ATTR disease from the aspects of nonclinical effectiveness and nonclinical safety to provide information for new drug development in China.

Clinical position and effect evaluation are the key points of new drug research and development. Traditional Chinese medicine (TCM) clinical research often have problems such as unclear clinical position, effect evaluation not targeted, or do not tally with the characteristics of drug and so on. Recently, extensive investigation has been carried out with questionnaire on the revision of “the general principle of clinical research of new drug of TCM” on “how to determine the clinical position with characteristics of TCM” and “how to build effect evaluation system and evaluation standard with characteristics of TCM”, and participate experts give constructive advices. This article summarizes and analyzes experts' opinions, and discusses the author's opinion of TCM clinical position and effect evaluation system.

This article explained the purpose of analytical method validation, pointed out that there are many problems and misunderstandings about method validation in drug research and development, and gave some opinions and suggestions according to the authors' experience, expecting for higher demand from the regulatory authorities.

The COVID-19 epidemic has swept the world in 2020, posing a major threat to human life and health. The global biopharmaceutical landscape will also change. The Center for Drug Evaluation and Research (CDER) of the US FDA approved 53 innovative drugs in 2020, 40 of which were first approved worldwide. The European EMA approved 34 innovative medicines throughout the year, including 6 for the first approval in the world. Japan's Medical Products and Medical Devices Agency (PMDA) approved 38 innovative drugs throughout the year, including 13 for the first approval in the world. National Medical Products Administration (NMPA) approved 48 innovative drugs throughout the year, 9 of which were developed by local companies and approved for the first time in the world. The launch of these new drugs will provide brand new therapies or more treatment options for a variety of diseases. This paper reviewed the new drugs approved for the market in the US, EU, Japan and China in 2020, and gave a brief outlook on the new drug development in 2021, aiming to provide reference for people engaged in new drug research and development.

A total of 18 973 patents in the field of traditional Chinese medicine (TCM) from 2001 to 2019 applied by universities of China were retrieved through the incoPat patents analysis database. By statistical analysis of the application trend, the field of patents technologies, the legal status, patents transfer and licensing, foreign patents application and so on, combined with the patents analysis of typical universities in the field of TCM, this paper combed the current situation of technological innovation of TCM and patent protection in China's universities, and put forward suggestions for strengthening patent work in universities to promote technological innovation in the field of TCM.

Hyperuricemia results from excessive production of uric acid and/or physical excretion deficiency and is the core to formation and development of gout, which has caught attention of researchers due to increasing prevalence. The drugs currently used in clinic can control the development of gout, but still have various deficiencies. The hot spot of drugs under research is urate anion exchanger 1 (URAT1) inhibitor, but new conditions for old drug aiming at other targets are also worthy of attention. This article reviewed the progress in research on therapeutic drugs of hyperuricemia, aiming to provide reference for the development of new drugs.

Continuous manufacturing (CM) of solid dosage forms enables materials passing through integrated dispensing system, saving operation time and reducing human errors, thus is developing into a preferred platform for pharmaceutical products. European and American drug regulatory agencies have approved several commercial CM solid dosage form drugs. The role of control strategy for CM is based on scientific framework to identify and to reduce the risk of manufacturing variation. Process analysis technology (PAT) monitoring methods can improve product quality in real time, promote continuous improvement and innovation in manufacturing, and thus achieve advanced process control and real-time release of products. The ultimate goal is to bring safer medicines to the market more quickly and cost-effectively, as well as to achieve the digitalization and process analytics of pharmaceutical 4.0. This review article discussed the modeling and associated risk mitigation, advanced control strategies of PAT in the implementation of CM processes for solid dosage form products, and the potential challenges of regulator's expectations from industrial perspective. The current situation of new drug approvals and related PAT implementations from international pharmaceutical companies were also illustrated and discussed.