World Health Organization/United Nations Population Fund guidance on conducting post-market surveillance of condoms

Background:

The report of the Fifty-fourth meeting of the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) in 2019 (1)) stated the following:

As agreed at the ECSPP meeting in October 2018, the United Nations Population Fund (UNFPA) and WHO have separated out different aspects of the current procedure for contraceptive devices and condoms and are developing seven different documents:

■ prequalification programme guidance for contraceptive devices: male latex condoms, female condoms and intrauterine devices;

■ technical specifications for male latex condoms;

■ specifications for plain lubricants;

■ condom quality assurance;

■ guidance on testing of male latex condoms;

■ recommendations for condom storage and shipping temperatures; and

■ guidance on conducting post-market surveillance of condoms.

All seven documents were restructured and revised in the first half of 2019, then sent to the Expert Advisory Panel (EAP) and put out for public consultation in July 2019. The comments received were reviewed by a group of specialists in October 2019, prior to being presented to the ECSPP. At UNFPA’s request, the ECSPP focused on the first three documents (on UNFPA’s Prequalification Programme guidance, condom quality assurance and specifications for plain lubricants), noting that all comments have been addressed. It suggested some further minor revisions, including recommending changes to clarify that, while the specifications for plain lubricants are principally targeted at procurement agencies, they may also be used by regulators for public procurement. The next steps for the remaining four documents include incorporating comments from the latest consultations and then bringing them back to the ECSPP for possible adoption at its next meeting in 2020.

The Expert Committee adopted the following guidelines:

■ World Health Organization/United Nations Population Fund Prequalification Programme guidance for contraceptive devices: male latex condoms, female condoms and intrauterine devices (2);

■ World Health Organization/United Nations Population Fund technical specifications for male latex condoms (3); and

■ World Health Organization/United Nations Population Fund specifications for plain lubricants (4).

The Expert Committee further recommended proceeding with the next steps as discussed.

This is one of four remaining working documents in this series.

Click on the following title for full details: pdf

Table of Contents

1. Introduction

2. Sampling

3. Testing

4. Selection of laboratories

5. Interpretation of results

References