World Health Organization (WHO) 50th report

World Health Organization (WHO) 50th report

Expert Committee on Specifications for Pharmaceutical Preparations (WHO Technical Report Series, No. 996) successfully passed the 139th session of the Executive Board on Tuesday, 31 May 2016.


The following guidelines, as contained in the Annexes to the Expert Committee’s fiftieth report, are now recommended for use:

• Annex 1:
Good pharmacopoeial practices (new)

• Annex 2:
International Pharmaceutical Federation–WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products (new)

• Annex 3:
Guidance on good manufacturing practices for biological products (revision), following its adoption by the Expert Committee on Biological Standardization on 16 October 2015

• Annex 4:
Guidance on good manufacturing practices: inspection report, including a model report (revision)

• Annex 5:
Guidance on good data and record management practices (new)

• Annex 6:
Good trade and distribution practices for pharmaceutical starting materials (revision)

• Annex 7:
Guidelines on the conduct of surveys of the quality of medicines (new)

• Annex 8:
Collaborative procedure between WHO’s Prequalification Team and national regulatory authorities in the assessment and accelerated national registration of WHO prequalified pharmaceutical products and vaccines (revision)

• Annex 9:
Guidance for organizations performing in vivo bioequivalence studies (revision)

• Annex 10:
WHO general guidance on variations to multisource pharmaceutical products (new).