Guidance documents

31 January 2013

Recommendations to assure the quality, safety and efficacy of BCG vaccines, Annex 3, TRS No 979 Recommendations to assure the quality, safety and efficacy of BCG vaccines, Annex 3, TRS No 979

19 November 2004

Guidelines for the production and control of inactivated oral cholera vaccine, Annex 3, TRS No 924 Guidelines for the production and control of inactivated oral cholera vaccine, Annex 3, TRS No 924

10 March 2021

Guidelines on the quality, safety and efficacy of plasmid DNA vaccines, Annex 2, TRS No 1028 Guidelines on the quality, safety and efficacy of plasmid DNA vaccines, Annex 2, TRS No 1028

13 January 2014

Recommendations to assure the quality, safety and efficacy of DT-based combined vaccines, Annex 6, TRS No 980 Recommendations to assure the quality, safety and efficacy of DT-based combined vaccines, Annex 6, TRS No 980

8 October 2013

Guidelines on the quality, safety and efficacy of dengue tetravalent vaccines (live, attenuated), Annex 2, TRS No 979 Guidelines on the quality, safety and efficacy of dengue tetravalent vaccines (live, attenuated), Annex 2, TRS No 979

19 November 2014

Recommendations to assure the quality, safety and efficacy of diphtheria vaccines (adsorbed), Annex 4, TRS No 980 Recommendations to assure the quality, safety and efficacy of diphtheria vaccines (adsorbed), Annex 4, TRS No 980

31 March 2007

Guidelines for assuring the quality and non clinical safety evaluation of DNA vaccines, Annex 1, TRS 941 Guidelines for assuring the quality and non clinical safety evaluation of DNA vaccines, Annex 1, TRS 941

17 July 2018

Guidelines on the quality, safety and efficacy of Ebola vaccines, Annex 2, TRS No 1011 Guidelines on the quality, safety and efficacy of Ebola vaccines, Annex 2, TRS No 1011

11 May 2021

Recommendations to assure the quality, safety and efficacy of enterovirus 71 vaccines (inactivated), Annex 3, TRS No 1030 Recommendations to assure the quality, safety and efficacy of enterovirus 71 vaccines (inactivated), Annex 3, TRS No 1030

25 May 2000

Recommendations for the production & control of Haemophilus influenzae type b conjugate vaccines, Annex 1, TRS No 897 Recommendations for the production & control of Haemophilus influenzae type b conjugate vaccines, Annex 1, TRS No 897

25 May 2013

Recommendations to Assure the Quality, Safety and Efficacy of Recombinant Hepatitis B Vaccines, Annex 4, TRS No 978 Recommendations to Assure the Quality, Safety and Efficacy of Recombinant Hepatitis B Vaccines, Annex 4, TRS No 978

25 May 2019

Recommendations to assure the quality, safety and efficacy of recombinant Hepatitis E vaccines, Annex 2, TRS No 1016 Recommendations to assure the quality, safety and efficacy of recombinant Hepatitis E vaccines, Annex 2, TRS No 1016

25 May 2016

Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines, Annex 4, TRS No 999 Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines, Annex 4, TRS No 999

1 January 2005

Recommendations for the production and control of influenza vaccine (inactivated), Annex 3, TRS No 927 Recommendations for the production and control of influenza vaccine (inactivated), Annex 3, TRS No 927

2 January 2013

Recommendations to assure the quality, safety and efficacy of influenza vaccines (human, live attenuated) for intranasal administration, Annex 4, TRS No 977 Recommendations to assure the quality, safety and efficacy of influenza vaccines (human, live attenuated) for intranasal administration, Annex 4, TRS No 977

2 January 2008

Guidelines on regulatory preparedness for human pandemic influenza vaccines, Annex 2, TRS 963 Guidelines on regulatory preparedness for human pandemic influenza vaccines, Annex 2, TRS 963

25 April 2024

TRS 1054 - Annex 2 - Guidelines on regulatory preparedness for the oversight of pandemic or other emergency use vaccines in importing countries TRS 1054 - Annex 2 - Guidelines on regulatory preparedness for the oversight of pandemic or other emergency use vaccines in importing countries

2 January 2019

Guidelines for the safe development and production of vaccines to human pandemic influenza viruses and influenza viruses with pandemic potential, Annex 3, TRS No 1016 Guidelines for the safe development and production of vaccines to human pandemic influenza viruses and influenza viruses with pandemic potential, Annex 3, TRS No 1016

31 January 2012

Generic protocol for the calibration of seasonal and pandemic influenza antigen working reagents by WHO essential regulatory laboratories, Annex 5, TRS No 979 Generic protocol for the calibration of seasonal and pandemic influenza antigen working reagents by WHO essential regulatory laboratories, Annex 5, TRS No 979

9 May 2017

WHO Working Group Meeting on Revision of WHO TRS No 941, Annex 5: WHO Biosafety Risk Assessment and Guidelines for the Production and Quality Control of Human Influenza Pandemic Vaccines WHO Working Group Meeting on Revision of WHO TRS No 941, Annex 5: WHO Biosafety Risk Assessment and Guidelines for the Production and Quality Control of Human Influenza Pandemic Vaccines

1 December 2011

Recommendations for Japanese encephalitis vaccine (inactivated) for human use, Annex 1, TRS No 963 Recommendations for Japanese encephalitis vaccine (inactivated) for human use, Annex 1, TRS No 963

15 May 2014

Recommendations to assure the quality, safety and efficacy of Japanese encephalitis vaccines (live, attenuated) for human use, Annex 7, TRS No 980 Recommendations to assure the quality, safety and efficacy of Japanese encephalitis vaccines (live, attenuated) for human use, Annex 7, TRS No 980

3 July 2014

Guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum, Annex 3, TRS No 980 Guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum, Annex 3, TRS No 980

23 October 2011

Recommendations to assure the quality, safety and efficacy of Group A Meningococcal Conjugate vaccines, Annex 2, TRS No 962 Recommendations to assure the quality, safety and efficacy of Group A Meningococcal Conjugate vaccines, Annex 2, TRS No 962

1 January 2004

Recommendations for the production and control of Meningococcal group C conjugate vaccines, Annex 2, TRS No 924 Recommendations for the production and control of Meningococcal group C conjugate vaccines, Annex 2, TRS No 924

1 January 2004

Recommendations for the production and control of group C meningococcal conjugate vaccines, Annex 3, TRS No 926 Recommendations for the production and control of group C meningococcal conjugate vaccines, Annex 3, TRS No 926

1 January 2011

Recommendations Part C: Clinical evaluation of group C meningococcal conjugate vaccines, Annex 3, TRS No 963 Recommendations Part C: Clinical evaluation of group C meningococcal conjugate vaccines, Annex 3, TRS No 963

1 January 2004

Recommendations for whole-cell pertussis vaccine, Annex 6, TRS No 941 Recommendations for whole-cell pertussis vaccine, Annex 6, TRS No 941

1 January 2005

Recommendations for Diphtheria, tetanus, pertussis and combined vaccines, Annex 5, TRS No 927 Recommendations for Diphtheria, tetanus, pertussis and combined vaccines, Annex 5, TRS No 927

13 January 2014

Recommendations to assure the quality, safety and efficacy of acellular pertussis vaccines, Annex 4, TRS No 979 Recommendations to assure the quality, safety and efficacy of acellular pertussis vaccines, Annex 4, TRS No 979

19 October 2013

Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines, Annex 3, TRS No 977 Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines, Annex 3, TRS No 977

19 October 2019

Guidelines for the safe production and quality control of poliomyelitis vaccines, Annex 4, TRS No 1016 Guidelines for the safe production and quality control of poliomyelitis vaccines, Annex 4, TRS No 1016

6 November 2020

Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated), Annex 3, TRS No 1024 Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated), Annex 3, TRS No 1024

6 November 2015

Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated), Annex 3, TRS No 993 Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated), Annex 3, TRS No 993

6 November 2014

Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (oral, live, attenuated), Annex 2, TRS No 980 Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (oral, live, attenuated), Annex 2, TRS No 980

31 March 2000

Guidelines for implementing the pre-eradication phase of the global action plan for laboratory containment of wild polioviruses Guidelines for implementing the pre-eradication phase of the global action plan for laboratory containment of wild polioviruses

2 September 2020

Guidelines for the safe production and quality control of poliomyelitis vaccines, Annex 3, TRS No 1028 Guidelines for the safe production and quality control of poliomyelitis vaccines, Annex 3, TRS No 1028

1 January 2007

Recommendations for inactivated rabies vaccine for human use produced in cell substrates and embryonated eggs, Annex 2, TRS No 941 Recommendations for inactivated rabies vaccine for human use produced in cell substrates and embryonated eggs, Annex 2, TRS No 941

11 November 2020

Guidelines on the quality, safety and efficacy of respiratory syncytial virus vaccines, Annex 2, TRS No 1024 Guidelines on the quality, safety and efficacy of respiratory syncytial virus vaccines, Annex 2, TRS No 1024

6 November 2024

Recommendations to assure the quality, safety and efficacy of rotavirus vaccines (Replacement of Annex 3 of WHO Technical Report Series, No. 941) Recommendations to assure the quality, safety and efficacy of rotavirus vaccines (Replacement of Annex 3 of WHO Technical Report Series, No. 941)

1 June 2003

Recommendations for the production and quality control of smallpox vaccine, revised 2003, Annex 1, TRS No 926 Recommendations for the production and quality control of smallpox vaccine, revised 2003, Annex 1, TRS No 926

1 January 1999

Guidelines for the prodution and quality control of synthetic peptide vaccines, Annex 1, TRS No 889 Guidelines for the prodution and quality control of synthetic peptide vaccines, Annex 1, TRS No 889

15 May 2014

Recommendations to assure the quality, safety and efficacy of tetanus vaccines (adsorbed), Annex 5, TRS No 980 Recommendations to assure the quality, safety and efficacy of tetanus vaccines (adsorbed), Annex 5, TRS No 980

5 November 2020

Recommendations to assure the quality, safety and efficacy of typhoid conjugate vaccines, Annex 2, TRS No 1030 Recommendations to assure the quality, safety and efficacy of typhoid conjugate vaccines, Annex 2, TRS No 1030

15 May 2013

Recommendations to assure the quality, safety and efficacy of live attenuated yellow fever vaccines, Annex 5, TRS No 978 Recommendations to assure the quality, safety and efficacy of live attenuated yellow fever vaccines, Annex 5, TRS No 978

18 June 2014

Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology, Annex 4, TRS No 987 Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology, Annex 4, TRS No 987

14 January 2016

Regulatory assessment of approved rDNA-derived biotherapeutics, Annex 3, TRS No 999 Regulatory assessment of approved rDNA-derived biotherapeutics, Annex 3, TRS No 999

1 January 2018

Guidelines on procedures and data requirements for changes to approved biotherapeutic products, Annex 3, TRS No 1011 Guidelines on procedures and data requirements for changes to approved biotherapeutic products, Annex 3, TRS No 1011

1 January 2010

Guidelines on evaluation of similar Biotherapeutic Products (SBPs), Annex 2, TRS No 977 Guidelines on evaluation of similar Biotherapeutic Products (SBPs), Annex 2, TRS No 977

16 January 2017

Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs), Annex 2, TRS No 1004 Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs), Annex 2, TRS No 1004

1 January 1989

Requirements for human interferons prepared from lymphoblastoid cells, Annex 3, TRS No 786 Requirements for human interferons prepared from lymphoblastoid cells, Annex 3, TRS No 786

18 June 2016

Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions, Annex 5, TRS No 999 Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions, Annex 5, TRS No 999

22 May 2013

Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks, Annex 3, TRS No 978 Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks, Annex 3, TRS No 978

6 November 2015

Scientific principles for regulatory risk evaluation on finding an adventitious agent in a marketed vaccine, Annex 2, TRS No 993 Scientific principles for regulatory risk evaluation on finding an adventitious agent in a marketed vaccine, Annex 2, TRS No 993

11 January 2017

Guidelines on clinical evaluation of vaccines: regulatory expectations, Annex 9, TRS No 1004 Guidelines on clinical evaluation of vaccines: regulatory expectations, Annex 9, TRS No 1004

11 January 2017

Human challenge trials for vaccine development: regulatory considerations, Annex 10, TRS No 1004 Human challenge trials for vaccine development: regulatory considerations, Annex 10, TRS No 1004

19 August 2016

WHO good manufacturing practices for biological products, Annex 2, TRS No 999 WHO good manufacturing practices for biological products, Annex 2, TRS No 999

18 October 2010

Guidelines for Independent Lot Release of Vaccines by Regulatory Authorities, Annex 2, TRS No 978 Guidelines for Independent Lot Release of Vaccines by Regulatory Authorities, Annex 2, TRS No 978

1 January 2005

WHO guidelines on non-clinical evaluation of vaccines, Annex 1, TRS No 927 WHO guidelines on non-clinical evaluation of vaccines, Annex 1, TRS No 927

18 October 2014

Guidelines on the non-clinical evaluation of vaccine adjuvants and adjuvanted vaccines, Annex 2, TRS No 987 Guidelines on the non-clinical evaluation of vaccine adjuvants and adjuvanted vaccines, Annex 2, TRS No 987

16 September 1991

Guidelines for national authorities on quality assurance for biological products, Annex 2, TRS No 822 Guidelines for national authorities on quality assurance for biological products, Annex 2, TRS No 822

18 October 2015

Guidelines on procedures and data requirements for changes to approved vaccines, Annex 4, TRS No 993 Guidelines on procedures and data requirements for changes to approved vaccines, Annex 4, TRS No 993

11 July 1995

Regulation and licensing of biological products in countries with newly developing Regulatory Authorities, Annex 1, TRS No 858 Regulation and licensing of biological products in countries with newly developing Regulatory Authorities, Annex 1, TRS No 858

23 October 2011

Guidelines on Stability Evaluation of Vaccines, Annex 3, TRS No 962 Guidelines on Stability Evaluation of Vaccines, Annex 3, TRS No 962

1 January 2004

Guidelines on regulatory expectations related to the elimination, reduction or replace of thiomersal in vaccines, Annex 4, TRS 926 Guidelines on regulatory expectations related to the elimination, reduction or replace of thiomersal in vaccines, Annex 4, TRS 926

16 September 2003

WHO Guidelines on Transmissible Spongiform Encephalopathies in relation to Biological and Pharmaceutical Products WHO Guidelines on Transmissible Spongiform Encephalopathies in relation to Biological and Pharmaceutical Products

16 September 2006

WHO Guidelines on Tissue infectivity distribution in Transmissible Spongiform Encephalopathies WHO Guidelines on Tissue infectivity distribution in Transmissible Spongiform Encephalopathies

1 October 1973

General requirements for the sterility of biological substances, Annex 4, TRS No 530 General requirements for the sterility of biological substances, Annex 4, TRS No 530

1 October 1973

General requirements for the sterility of biological substances, Annex 3, TRS No 872 General requirements for the sterility of biological substances, Annex 3, TRS No 872