At the end of last month, the WHO announced the implementation of a new financing model for their Prequalification programme, to take effect in January 2017. The detailed scheme and other questions and answers that any manufacturers may have are also available on the WHO website.
Inresa Arzneimittel GmbH have achieved WHO prequalification on 15 August 2016 for their magnesium sulfate heptahydrate (MgSO4) 500 mg/ml injection with technical assistance from Concept Foundation. This is the first such product to be prequalified. On the same day, China Resources Zizhu have had their mifepristone 200mg product added to the list of WHO prequalified medicines for use in combination with misoprostol, as have Jai Pharma Ltd with their levonorgestrel 0.03mg progestin-only contraceptive.
Health Concepts International (HCI), Concept Foundation's subsidiary laboratory in Thailand, has been prequalified by the WHO as a quality control laboratory.
The WHO PQ team has announced the prequalification of a second mifepristone product, manufactured by Exelgyn in France.
Fiona Theunissen, MBA and Dr Hans Vemer, CEO of Concept Foundation and former obstetrician, discuss why quality, which is by no means a given, is such an important consideration when purchasing maternal health medicines such as uterotonics.
The Indian pharmaceutical company ACME Formulation Pvt. Ltd. have achieved WHO prequalification for their Misoprostol 200µg product, with technical assistance provided by Concept Foundation.
The WHO PQ has announced a pilot collaborative registration procedure for SRA-approved medicines. Products being included in this pilot are medicines for HIV, TB, and antimalarials, as well as RH products such as contraceptives and maternal health medicines.
The United Nations Population Fund (UNFPA) has issued its 9th Invitation to Manufacturers of Reproductive Health Medicines to Submit an Expression of Interest (EOI) for Product Evaluation by the WHO Expert Review Panel (ERP).