Whole cell Pertussis

PUBLIC CONSULTATION - DEADLINE: 18 APRIL 2014

• Draft Good Review Practices Guidelines for Regulatory Authorities
  pdf, 639kb
• Comment Form
  doc, 43kb

PUBLIC CONSULTATION - DEADLINE: 31 March 2014

• Guidelines for Procedures and Data Requirements for Changes to Approved Vaccines
  pdf, 837kb
• Comment Form
  doc, 60kb

PUBLIC CONSULTATION - DEADLINE: 12 March 2014

• Regulatory Expections and Risk Assessment for Biotherapeutic Products
  pdf, 443kb
• Comment Form
  doc, 50kb

NEW PUBLICATIONS

• Technical Report Series 980
  pdf, 2.22Mb
  WHO Expert Committee on Biological Standardization: TRS 980-63rd report
• WHO Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines
  pdf, 531kb
• WHO Guidelines on the quality, safety and efficacy of typhoid conjugate vaccines
  pdf, 1.26Mb
• WHO Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology
  pdf, 925kb
• Technical Report Series
  WHO Expert Committee on Biological Standardization: TRS 977-60th report, TRS 978-61st report and TRS 979-62nd report

RECENT PUBLICATIONS

WHO Informal Consultation on Recommendations to Assure the Quality, Safety and Efficacy of Poliomyelitis Vaccine, Inactivated (IPV)

25-26 March 2014, Geneva, Switzerland

WHO Drafting Group Meeting on the Revision of TRS 962, Annex 1

(Guidelines to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines) 29-30 April 2014, WHO/HQ, Geneva

Implementation Workshop on Evaluation of Biotherapeutic Products and Evaluation of Similar Biotherapeutic products with emphasis on Monoclonal Antibody Products

13-16 May 2014, Seoul, The Republic of Korea

CONTACTS

Quality, Safety and Standards (QSS)
Immunization, Vaccines and Biologicals (IVB)
World Health Organization (WHO)
Avenue Appia 20
1211 Geneva 27, Switzerland
Fax No. +41 22 7914971