FCMi Product Selection Guide: meeting relevant regulatory requirements

 

Introduction

Below, FCMi provides buyers a high-level guide on procurement and supply chain management of female condoms. Specifically, it provides them a guide on the selection of quality-assured female condoms available in a given market.

The supply chain cycle, illustrated herewith, demonstrates the different activities involved in the management of health commodities. Selection is an essential step in this process in ensuring that only products of assured-quality are procured, supplied and used. This is followed by forecasting and quantification, an exercise to estimate the quantities to be procured. Proper warehouse and distribution contributes to effective management of the goods including timely delivery, avoiding wastages and ensuring quality. Rational use is established by ensuring that the product is used for its intended purpose (indication) by the right patient (user), in the right amount (dose/quantity), in the right form, for an adequate period of time and at the lowest possible cost. 

Selection:

 

Meeting regulatory requirements

In order to understand which products will be available for procurement in a given market, it is first important to understand how the country classifies and regulates female condoms. If the country has classified female condoms as a medical device for instance or it appears on the national essential medicines list (EML), female condoms will usually have to obtain certain regulatory approvals. In most cases, subsequent to the producer submitting a satisfactory product dossier and having the manufacturing site inspected to meet ISO or other relevant standards.

In summary, the female condoms eligible for procurement in a given market will be those that have market authorisation and meet the relevant regulatory requirements. These requirements will vary from country to country and will usually be determined by how female condoms are classified in the given market. It is therefore critical that procurers understand the regulatory system in his or her country before identifying which female condoms are eligible for procurement. FCMi intends to map out how different countries manage the procurement and importation of female condoms and to build up a registration database of which female condom products are registered across the globe. For the time being, FCMi’s Product Progress page provides information on the current range of female condoms on the market and the countries in which they are available.

Below are short explanations on different regulatory approvals/certifications that apply to female condoms.

 

CE Marking

Female condoms are classified as a medical device. According to the EU medical device directive (93/42/EEC), all medical devices must meet applicable essential requirements on safety, performance and labelling before it is placed on the market. Placing on the market means affixing CE marking on the product. In order to do so, manufacturers apply for their product to undergo conformity assessment. In summary, conformity assessment involves demonstrating satisfactory quality management systems (QMS) such as EN ISO 13485 or ISO 9001, evaluation of technical documentation/file, audit of manufacturing operations and declaration of conformity by the manufacturer following which certification is issued. The contents of the technical file includes, but not limited to, the following: detailed information about the product (classification, intended use, design, descriptions etc.), clinical evaluation/investigation report, results of risk analysis, instruction for use and post-market surveillance system. In accordance with Article 17 of 93/42/EEC the device, the sales pack and the instructions for use must show the CE mark, accompanied by the Notified Body number responsible for implementation of the procedures e.g. 0483 for MDC. Currently 5 of the female condoms featured on FCMi carry a CE marking.

In the EU, conformity assessment and certificate is done by a notified body, an organisation accredited by a member state. Each member state, in turn, have a designated competent authority, to act on their behalf and ensure that member state government transposes requirements of medical device directives into national law and implements them. For e.g. in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority.

WHO/UNFPA Prequalification

A prequalified female condom requires that the product has been approved by the WHO/RHR Technical Review Committee. This is based on a detailed evaluation of the product dossier, inspection of manufacturing site and independent testing of the product. Manufacturers must meet the minimum requirements detailed in the relevant ISO standards in including ISO 25841: 2011 and the detailed prequalification procedures outlined in the WHO/UNFPA Female Condom: Generic Specification, Prequalification and Guidelines for Procurement, 2012

The prequalification process begins with the manufacturers of female condoms submitting an expression of interest (EoI) to WHO/UNFPA, including:

  • Product dossier, in English, submitting product data and information.
  •  A Site Master File, in English, for each manufacturing site listed in the product dossier.
  •  Quality Manual.
  • Copies of all market licenses; ISO and Quality Certifications.
  • Ten samples of each product in its final packaging to enable visual inspection of the product, the packaging materials and the label.

A two day inspection of the manufacturing site will be then performed by a team of inspectors, appointed by UNFPA. Based on evidence collected and the outcome of the inspection, a decision is made on whether the manufacturer is eligible to be prequalified or not. Re-assessments are done at intervals of no more than three years.

Current WHO/UNFPA prequalified female condoms / manufacturing sites (see FCMi's overview of these products).

 

Procurement with donor funds

Although the global supply of female condoms is growing, in many countries female condoms have only recently been supplied. Further, if they are supplied, they may only be supplied by institutional or bulk procurers funded by international donors. But how do these organisations select which female condoms can be supplied?

Below FCMi provides an overview of the eligibility criteria of two of the biggest bulk procurers: UNFPA and USAID. For a brief overview of the biggest bulk procurers of female condoms, click here.

 

UNFPA (United Nations Population Fund)

According to the AccessRH database, UNFPA was the largest procurer of female condoms in 2012, buying over 14M female condoms on behalf of its clients which include UNFPA field offices, Governments, NGOs, World Bank Borrowers as well as other UN organizations – see UNFPA website for more details. With regard to female condoms. UNFPA is committed to only purchasing female condoms from factories that have been pre-qualified according to the WHO/UNFPA Prequalification Scheme 

 

USAID (US Agency for International Development)

 

In 2012, USAID procured and supplied over 10M female condoms on behalf of recipient countries (RHAccess). In seeking USAID support in the procurement and supply of female condoms, the range of available female condoms will be limited to those products eligible for procurement by USAID. Currently, USAID uses the following eligibility criteria for the procurement of female condoms. According to the USAID presentation Meeting the Global Challenges for Family Planning: USAID Procurement Policies & Requirements, the product/supplier must be:

Stringent regulatory authority (SRA) approved:

  • have obtained a USFDA 510 (k) - what is this?
  • be ISO 13485 certified - what is this?
  • possess a GMP certificate from NDRA in country of manufacture
  • display evidence of conformance with relevant standard (e.g. ISO 25481:2011
 

The only current USAID/USFDA approved female condom is the FC2® female condom, Female Health Company (USFDA approved in March 2009 – see the announcement from the USFDA).

 

Procurement:

For a more comprehensive guide on managing the procurement of female condoms, FCMi recommends visitors to consult Female Condom: Generic Specification, Prequalification and Guidelines for Procurement, 2012jointly authored by the World Health Organization, Department of Reproductive Health and Research (WHO/RHR), the United Nations Population Fund (UNFPA), the United States Agency for International Development (USAID), the Bill and Melinda Gates Foundation and FHI360.

In Chapter 10 of the document, the fundamental steps in the procurement process are identified that enable country programmes to receive good-quality condoms in the right quantities, in the right condition, delivered to the right place, at the right time, for a reasonable cost. This chapter in particular, provides buyers of female condoms an excellent overview of how the procurement of female condoms should be managed and provides a procurement checklist template to help buyers ensure that they give full consideration to all the relevant steps in the procurement process.

Rather than duplicating this excellent resource, FCMi seeks to supplement this procurement guide by providing visitors a high-level guide to selection of quality-assured female condoms in a given setting. In addition, it also outlines key resources to assist in quality assurance and quality control of female condoms.