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The article presents the analysis of the World Health Organization Expert Committee on the collaborative studies which aim to replace the current International Reference Preparation. These collaborative studies had assessed the relative sensitivity of cell culture assays and chorioallantoic membrane egg assays for smallpox vaccines as well as potency determination of yellow fever vaccines. Futhermore, the Committee stresses their agreement on the content of the studies.

The article focuses on the international guidelines and recommendations developed by the World Health Organization Expert Committee which depict on the manufacturing and quality control of biological products. The Committee has developed a draft for nonclinical evaluation of vaccines, which is intended to set principles as well as provide information and guidance to vaccine manufacturers. The Committee also reviewed the draft for the production and control of pneumococcal conjugate vaccines.

The article offers information about the activities of the World Health Organization Expert Committee on the development of biological standards. The Committee has established a standardization program, which aims to develop recommendations for quality standards, provision of reference materials, and consensus on quality-related issues for biologicals. Furthermore, the Committee has developed of a vaccine for severe acute respiratory syndrome.

Annex 1 of the book "WHO Expert Committee on Biological Standardization: fifty-second report" is presented. It provides outline of the international regulatory expectations which are applicable to the different stages of vaccine development and marketing approval. It explores further guidance on preclinical and laboratory evaluation of vaccines.

The article focuses on the international guidelines and recommendations developed by the World Health Organization Expert Committee which depict on manufacturing and quality control of biologicals. These international guidelines are developed to provide guidance on regulatory expectations for clinical evaluation of vaccines. Furthermore, the organization recommended vaccines for meningococcal polysaccharide and has established international workshops on antivenoms.

The article offers information about the activities of the World Health Organization (WHO) Expert Committee on the development of biological standards. Biological standards include guidelines and recommendations in increasing the use of molecular methods for the characterization of vaccines. WHO also established workshops and seminar sessions in dealing with blood products as well as consultation on bioterrorism in preparation for terrorism-related incidents.

Information about several papers discussed at the World Health Organization Expert Committee on Biological Standardization meeting is presented. The meeting highlights the increasing complexity, sophistication, and number of biological products. Major challenges on standardization and development of traditional biologicals were discussed.