Mylan Laboratories Limited has received a risk category 1 ranking from the WHO Expert Review Panel for its generic injectable, medroxyprogesterone acetate depot 150mg/ml.
Expansion of available prequalified MPA API
person
folder_openWHO PQ
A 2nd medroxyprogesterone acetate API has been prequalified by the WHO PQT, manufactured by Taizhou Taifa Pharmaceutical Co Ltd.
Fourth Misoprostol product prequalified by WHO PQ
person
folder_openWHO PQ
The World Health Organisation Prequalification team have announced the prequalification of a fourth generic misoprostol 200μg product, manufactured by China Resources Zizhu Pharmaceutical Co. Ltd.
New Financing Model Announced for WHO Prequalification of Medicines and Vaccines
person
folder_openWHO PQ
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.
3 reproductive health medicines prequalified, including first magnesium sulfate product
person
folder_openWHO PQ
turned_in_notLevonorgestrel, magnesium sulfate, maternal health, mifepristone, technical assistance, WHO PQ
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) is WHO prequalified
Health Concepts International (HCI), Concept Foundation’s subsidiary laboratory in Thailand, has been prequalified by the WHO as a quality control laboratory.
Second Mifepristone product prequalified by WHO PQ
The WHO PQ team has announced the prequalification of a second mifepristone product, manufactured by Exelgyn in France.
ACME has Misoprostol product prequalified by the WHO
person
folder_openWHO PQ
The Indian pharmaceutical company ACME Formulation Pvt. Ltd. have achieved WHO prequalification for their Misoprostol 200µg product, with technical assistance provided by Concept Foundation.
Pilot collaborative registration procedure for SRA-approved medicines
person
folder_openWHO PQ
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.
UNFPA releases updated list of medicines with positive recommendation from ERP
person
folder_openWHO PQ
UNFPA have updated the list of medicines that are available for procurement based on a positive recommendation from the Expert Review Panel (ERP).
News & Events
- From Concept Foundation: July 2019
- Concept Foundation announces A. Metin Gülmezoglu as its new Executive Director
- Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial results released
- World Preeclampsia Day – Access to quality magnesium sulfate to reduce maternal mortality
- WHO/UNICEF/UNFPA Joint Statement: Appropriate Storage and Management of Oxytocin – a Key Commodity for Maternal Health