Biologicals are a class of medicines made from living cells taken from plants, animals or bacteria. These cells are use in creating many types of health care products, including vaccines. This group of medicines also includes products derived from human blood and plasma for the treatment of many life-threatening diseases and for surgical procedures.
This year’s International Day for Biological Diversity, on Thursday, 22 May 2025, highlights the inherent connections between people and the natural world through the theme, “Harmony with nature and sustainable development”. It underscores the need to achieve the Kunming-Montreal Global Biodiversity Framework (GBF) targets to halt and reverse biodiversity loss – interlinked with ...
The WHO Expert Committee on Biological Standardization (ECBS) was established in 1947 to provide detailed recommendations and guidelines for the manufacturing, licensing and control of blood products and related in vitro diagnostic tests, biotechnology products and vaccines along with the establishment of WHO Biological Reference Materials. The ECBS meets on an annual basis and reports ...
Gender interacts with but is different from sex, which refers to the different biological and physiological characteristics of females, males and intersex persons, such as chromosomes, hormones and reproductive organs.
Overview Full version of the WHO Technical Report Series N° 999 Guidelines published by WHO are intended to be scientific and advisory in nature. Each of the following sections constitutes guidance for national regulatory authorities (NRAs) and for manufacturers of biological products. If an NRA so desires, these WHO Guidelines may be adopted as definitive national requirements, or ...
Good manufacturing practices (GMP) for biological products were first published by WHO in 1992 (1). This current revision reflects subsequent developments that have taken place in science and technology, and in the application of risk-based approaches to GMP (2–14). The content of this document should be considered complementary to the general recommendations set out in the current WHO good ...
This fourth edition of the manual builds on the risk assessment framework introduced in the third edition. A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis.
APIs produced by fermentation and APIs of biological, biotechnological or herbal origin are treated as special cases. The applicant is requested to contact WHO/PQP regarding planned variations to such products.