M Screening checklist for biotherapeutic products and their corresponding SBPs - Abridged Pathway DOCX
M Section guidance for part 3 — patient information leaflet (PIL) — of a WHO Public Assessment Report (WHOPAR) (24 October 2016) PDF
M Section guidance for part 4 — summary of product characteristics (SmPC) — of a WHO Public Assessment Report (WHOPAR) (25 October 2016) PDF
M Section guidance for part 5 — labelling — of a WHO Public Assessment Report (WHOPAR) (24 October 2016) PDF
M Section guidance for part 6 of — scientific discussion — of a WHO Public Assessment Report (WHOPAR) (25 October 2016) PDF
M Stability data for finished pharmaceutical products (FPPs) approved by stringent regulatory authorities (SRAs) PDF
M Stability testing of active pharmaceutical ingredients and finished pharmaceutical products - TRS 1010 - Annex 10 PDF
M Stability testing of active pharmaceutical ingredients and finished pharmaceutical products - WHO Technical Report Series, No.1010, Annex 10, 2018 PDF
ID Standard operating procedure 001: How to develop and publish a PQS product performance specification (1 April 2020) PDF
ID Standard operating procedure 002: How to review and revise a PQS product performance specification (1 April 2020) PDF
ID Standard operating procedure 003: How to withdraw a PQS product performance specification (1 April 2020) PDF
ID Standard operating procedure 004: How to develop and publish a PQS product verification protocol (1 April 2020) PDF
ID Standard operating procedure 005: How to review and revise a PQS product verification protocol (1 April 2020) PDF
ID Standard operating procedure 006: How to withdraw a PQS product verification protocol (1 April 2020) PDF
ID Standard operating procedure 007: How to assess a laboratory for PQS accreditation (1 April 2020) PDF
ID Standard operating procedure 008: How to re-evaluate a WHO PQS-accredited test laboratory (1 April 2020) PDF
ID Standard operating procedure 009: How to evaluate applications for product prequalification (1 April 2020) PDF
ID Standard operating procedure 010: How to re-evaluate a prequalified PQS product (1 April 2020) PDF
ID Standard operating procedure 011: How to remove a prequalified product from the PQS database (1 April 2020) PDF
ID Standard operating procedure 013: How to obtain feedback on the performance of a PQS product (1 April 2020) PDF
ID Standard operating procedure 014: How to audit a laboratory for PQS accreditation (1 April 2020) PDF
M Stringent regulatory authority sharing of non-public information concerning product with the national regulatory authority and the World Health Organization (WHO), Annex 3A DOCX
M Survey of the quality of anti-tuberculosis medicines circulating in selected newly independent states of the former Soviet Union (issued November 2011) PDF
M Survey of the quality of antiretroviral medicines circulating in selected African countries (issued September 2007) PDF
M Survey of the quality of medicines identified by the United Nations Commission on Life Saving Commodities for women and children PDF
M Survey of the quality of selected antimalarial medicines circulating in six countries of sub-Saharan Africa (issued January 2011) PDF
M Survey of the quality of selected antiretroviral medicines circulating in five African countries (2019) PDF