The portal provides guidance on quality standards for different RH commodities such as WHO prequalification status and registration status in countries classified as stringent regulatory authorities (SRA). Below is a short explanation of these different standards.
WHO prequalification programme aims to make quality priority medicines available for the benefit for those in need, in close cooperation with national regulatory agencies and partner organizations, the Prequalification Programme aims to make quality priority medicines available for the benefit of those in need. This is achieved through its evaluation and inspection activities, and by building national capacity for sustainable manufacturing and monitoring of quality medicines. The list of prequalified medicinal products used for HIV/AIDS, malaria, tuberculosis and for reproductive health is regularly published on the WHO website (http://apps.who.int/prequal/).
The prequalification scheme also extends to male condoms, female condoms and IUDs. As a result, WHO has published Specifications, Prequalification and Guidelines for Procurement for each of these products. These guidelines describes a technically sound, systematic process to support the manufacture, prequalification, procurement and distribution of a quality product that can meet the needs of different populations in a broad spectrum of challenging environmental conditions.
Stringent Regulatory Authority (SRA) approval
SRA are those national drug regulatory authorities which are members or observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) are considered as Stringent Regulatory Authority (SRA) as per the Global Fund Quality Assurance Policy for Pharmaceutical Products from July 1, 2009. For details on ICH, please visit www.ich.org.
Expert Review Panel (ERP)
In addition to the above, there is an interim mechanism which facilitates procurement of certain products while the manufacturers work towards obtaining WHO prequalification or SRA approval. This mechanism is known as Expert Review Panel (ERP) and the secretariat for ERP for RH medicines is managed by UNFPA. The procedure for ERP is initiated by an expression of interest for a list of products issued by UNFPA. An ERP approval is valid for 18 months.
Quality Standards for Medical Devices
Copper IUDs, male and female condoms are classified as medical devices and thus are subject to different quality standards.
For instance in the European Union, 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.
National Regulatory Requirements
The requirements to meet certain quality standards are defined by the quality assurance policy of the donor or that of the procurement agency. Additionally, most countries have their own requirements as stipulated in their national legislation or regulation. This usually necessitates medicinal products to be registered with the national regulatory authority (NRA) or a relevant competent authority of that country. The application procedures, documentary and other requirements for pharmaceuticals and medical devices vary.