World Health Organization/United Nations Population Fund Prequalification Programme guidance for contraceptive devices: male latex condoms, female condoms and intrauterine devices

Background:

The report of the Fifty-third meeting of the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) in 2018 (1) stated the following:

Ms Seloi Mogatle and Dr William Potter from the United Nations Population Fund (UNFPA) gave an update on the prequalification guidance for contraceptive devices and condoms. The UNFPA had contacted WHO to inquire how best to start a process to update the relevant texts that we adopted by the ECSPP and published in 2008 (2, 3). The Expert Committee agreed to the importance of updating these materials in view of the changes in the contraceptive field globally over the previous decade. The two organizations committed to work together to bring the documents up to date. It was suggested by UNFPA to separate out the current existing procedure for condoms to include the following aspects:

1. prequalification guidance for contraceptive devices;

2. prequalification programme for male latex condom and annexes;

3. technical specification for male latex condom and annexes;

4. male latex condom prequalification inspection aide memoire;

5. condom quality assurance and annexes;

6. guidance on testing male latex condoms;

7. condom storage and transportation;

8. post-market surveillance of condoms;

9. public assessment reports for contraceptive devices – condoms and intrauterine devices.

UNFPA also raised the issue of specifications for lubricants (both water based and silicon-based), which needs to be considered when developing the new guidelines.

The Expert Committee supported the development of the relevant documents for prequalification of condoms in consultation with the WHO Secretariat and their preparation for public consultation and took note that they will be reported back to the Expert Committee.

As agreed at the ECSPP meeting in October 2018, UNFPA and WHO have separated out different aspects of the current procedure for contraceptive devices and condoms.

All related documents were restructured and revised in the first half of 2019, then sent out for public consultation in July 2019. Comments received were reviewed by a group of specialists in October 2019, before being presented to the ECSPP. This is one of the three adopted by the Fifty-fourth ECSPP meeting to replace the previous guidance document.

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Table of Contents

1. Introduction

1.1 Objectives

2. The Prequalification Programme for reproductive health devices

2.1 Eligibility to participate

2.2 Application for prequalification: expression of interest

2.3 Site inspection

2.4 Product testing

2.5 Reporting and decision to prequalify

2.6 Listing of prequalified contraceptive devices and manufacturing sites

2.7 Maintenance of prequalification status