Since the Valsartan recall on July 2018, nitrosamine impurities such as N-nitrosodimethylamnie (NDMA), N-nitrosodiethylamine (NDEA), N-nitroso-N-methyl-4-aminobutyric acid (NMBA), N-nitrosodibutylamine (NDBA) have been successively detected in sartan and non-sartan drugs. Nitrosamine impurity investigation is mandatory for studies of chemical drugs. On May 8, 2020, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) issued the communication "Technical Guideline for Study of Nitrosamine Impurities in Chemical Drugs (for Trial Implementation)" (No. 1, 2020). The communication recommended to refer to the relevant provisions of ICH M7 (R1) guideline to ensure adequate and reasonable scientific basis of finally proposed control strategies and impurity limit; however, it did not specify a guideline for acceptance criterion establishment. This article discusses the establishment of acceptable limits for nitrosamine impurities.

Genotoxic impurities (GTIs) refer to a class of impurities in drugs that can directly or indirectly cause DNA damage and gene mutations, with carcinogenicity or potential carcinogenicity. To ensure the quality and safety of drugs, the European Medicines Agency (EMA) introduced regulations on the management of GTIs in 2002. Since then, organizations such as the US Food and Drug Administration (FDA) and the International Conference on Harmonisation (ICH) have also issued a series of guidelines on the definition, classification, limits, testing, and risk assessment procedures of GTIs. At present, GTIs have become one of the key indicators for drug approval and marketing, and also one of the top concerns for R&D personnel. By analyzing and summarizing the identification, classification, hazard assessment methods, limits, and other aspects of GTIs, this paper provides references for the control of GTIs.

In recent years, the global pharmaceutical industry has developed rapidly. In the past, CMO with single output capacity is gradually transforming into CDMO with high value-added technology output. It is expected that the global CMO/CDMO market will reach 102.5 billion US dollars in 2021.

In 2014, the biopharmaceutical industry witnessed more and more contract suppliers take on the CDMO (contract development and manufacturing organization) acronym to identify their ability to assist at the development stage of drug manufacturing. These businesses can provide comprehensive services, from drug development through to manufacturing commercial supply, and are interested in differentiating their abilities from CMOs focused solely on large-scale manufacturing projects…..

The pharmaceutical outsourcing industry has a development opportunity, and CMO reduces production cost Increase the income risk and cost pressures and other factors driving in dollars, rose to 2 billion 600 million of the cost of new drug research patents expire, pharmaceutical business mode from "vertical integration" gradually transformed into "open cooperation", the pharmaceutical industry outsourcing services including pharmaceutical CMO, usher in development opportunities.