The WHO Prequalification of Medicines programme (WHO-PQP) prequalified a record number of 9 products in a single day, of which 4 were generic reproductive health (RH) products. This demonstrates that the WHO-PQP programme for reproductive health medicines is achieving results. The RHSC Quality of Reproductive Health Medicines (QuRHM) programme, managed by Concept Foundation, is playing a major role in ensuring that generic products are entering the prequalification pipeline by providing technical support to manufacturers and by creating awareness of the need for prequalification of products by international donors and procurers within the manufacturing community. Together, these activities being undertaken by WHO and Concept Foundation are continuing to increase the availability of low cost, quality assured RH products for women and girls in low-income countries. Detailed results can be viewed on the QuRHM programme page.
Concept Foundation is pleased to announce the WHO pre-qualification of the second API for reproductive health medicines. Levonorgestrel API, manufactured by Qinhuangdao Zizhu Pharmaceutical Co Ltd, China (QZP) has been prequalified by the WHO Prequalification of Medicines Programme (PQP) under its API prequalification procedure. QZP is a subsidiary of China Resources Zizhu Pharmaceutical Co Ltd, who are a founding member of the RHSC Generic Manufacturers for Reproductive Health Caucus (GEM/RH), a group of generic manufacturers committed to providing quality assured medicines in support of RH and FP community aims. QZP are also participating in the RHSC Quality of Reproductive Health Medicines (QuRHM) programme managed by Concept Foundation.
Concept Foundation is pleased to announce the WHO pre-qualification of the first combined oral contraceptive pill (desogestrel and ethinylestradiol formulation), manufactured by Famycare India. Famycare Ltd are a founding member of the RHSC Generic Manufacturers for Reproductive Health Caucus (GEMs), a group of generic manufacturers committed to providing quality assured medicines in support of RH and FP community aims. Famycare are also participating in the RHSC Quality of Reproductive Health Medicines (QuRHM) programme managed by Concept Foundation.
Concept Foundation is pleased to announce the WHO pre-qualification (http://apps.who.int/prequal) of the first generic emergency contraceptive product, manufactured by Famycare in India. Famycare Ltd are a founding member of the RHSC Generic Manufacturers for Reproductive Health Caucus (GEM/RH), a group of generic manufacturers committed to providing quality assured medicines in support of RH and FP community aims. Famycare are also participating in the RHSC Quality of Reproductive Health Medicines (QuRHM) programme managed by Concept Foundation.
The Reproductive Health Supplies Coalition (RHSC) Quality of Reproductive Health Medicines (QuRHM) programme, managed by Concept Foundation is getting results. Quality active pharmaceutical ingredients (APIs) are a critical component of quality medicines. Ethinyl estradiol, manufactured by Qinhuangdao Zizhu Pharmaceutical Co Ltd, China (QZP) has been prequalified by the WHO Prequalification of Medicines Programme (PQP) under its API prequalification procedure. This is the first API prequalified for reproductive health medicines with the technical support of Concept Foundation.
As part of Concept Foundation’s work with the Reproductive Health Supplies Coalition (RHSC), the recently formed Generic Manufacturers Caucus for Reproductive Health (GEM/RH) will collaborate with RHSC to increase the availability of quality, affordable and safe reproductive health products and medicines to women, girls and families in need. GEM/RH comprises seven select generic manufacturers in Asia, Africa and Europe and will function as a Caucus within RHSC
Concept Foundation played the principal role in the production of new Guidelines for Bioequivalence Studies for Reproductive Health Medicines as part of the Quality of Reproductive Health Medicines (QuRHM) programme in collaboration with the WHO Prequalification of Medicines Programme.
This week, Sun Pharmaceutical Industries Ltd has received its first marketing authorizations in Europe for Medabon® from the Dutch Healthcare Inspectorate and the United Kingdom Medicines and Healthcare products Regulatory Agency. Click here for the full announcement.
The WHO Prequalification of Medicines Programme has published a briefing note on the Prequalification of Medicines for Reproductive Health. The document highlights the urgent need for more products in the reproductive health medicines pipeline considering the lack of quality assured reproductive health products available for procurement. It is also stressed that technical and regulatory support is available from both WHO PQP and Concept Foundation for manufacturers wishing to get their products prequalified, should they require it.
The document can be accessed via http://apps.who.int/prequal/info_press/documents/RH_briefing-note_April2012.pdf
A Meeting on Hormonal Contraceptives and other Essential Medicines was held at UNFPA headquarters in New York, 16-18th April.
The meeting was a follow up to an interagency consultation with procurers held by RHSC in Washington DC in May 2010 and focused on the harmonization and alignment of quality assurance policies and practices amongst international procurers. The meeting was part of the planned activities of RHSC’s Quality Reproductive Health Medicines (QuRHM) Programme and was hosted by UNFPA with the support of Concept Foundation.
Participants discussed the new Expert Review Panel for Reproductive Health Medicines (see below) and the upcoming Family Planning Summit hosted by DFID and the Bill & Melinda Gates Foundation.
For further information on the Family Planning Summit, see: http://www.dfid.gov.uk/News/Latest-news/2012/Family-planning-UK-to-host-summit-with-Gates-Foundation/
UNFPA has published a 2nd invitation to manufacturers of reproductive health medicines to submit an Expression of Interest (EOI) for Product Evaluation by the Expert Review Panel (ERP) for Reproductive Health Medicines, hosted and coordinated by WHO’s Quality and Safety of Medicines team.
The deadline for submission is 4th June 2012.
The EOI document can be accessed via the notices page on the United Nations Global Marketplace website, please see https://www.ungm.org/Notices/Item.aspx?Id=19681
Concept Foundation is continuing to work closely with the WHO Prequalification Programme (WHO/PQP) and together with WHO has updated and expanded the “Frequently Asked Questions” document that it developed in 2011. See: http://apps.who.int/prequal/info_press/pq_news_21March2012_QA-RH.htm
In order to speed up the process for manufacturer, WHO/PQP has proposed an “accelerated” procedure for the submission of dossiers for the prequalification of reproductive health products. See: http://apps.who.int/prequal/info_press/pq_news_21March2012_noteRH.htm
There is also an updated list of comparator products for bioequivalence studies on reproductive health products. See: http://apps.who.int/prequal/info_applicants/BE/Comparator-RH2012-20March.pdf
Medabon® Medical and Service Delivery Guidelines are now available in French, Spanish, Portuguese, Vietnamese and Thai in pdf to download or print.
For more information please visit:
Concept Foundation has produced a document addressing and analysing the emergence and impact of generic reproductive health medicines and the challenge to international and national procurers of ensuring the quality, safety and efficacy of products. It focuses specifically on the role of WHO´s Prequalification Programme in achieving this objective. This work was funded through the Innovation Fund of the Reproductive Health Supplies Coalition. Click here to download a copy.
In order to encourage and support manufacturers of generic reproductive health medicines in their application to have their products prequalified, by WHO´s Prequalification of Medicines Programme, Concept Foundation has produced a set of ´Frequently Asked Questions on the Prequalification of Medicines for Reproductive Health. Click here to download a copy of the Frequently Asked Questions on the Prequalification of Medicines for Reproductive Health.
The results from a study conducted in Nepal demonstrate that administration of early medical abortion is just as safe and effective when provided by midlevel healthcare professionals in comparison to qualified physicians. This randomised controlled equivalence trial was done in five rural district hospitals in Nepal. A total of 1295 women were randomly assigned either to a doctor (535) or to a nurse or midwife (542) for oral administration of 200 mg mifepristone followed by 800µg misoprostol 2 days later (Medabon®). The rates of complete abortion were 96.1% and 97.3% among women assigned to doctors and midlevel providers, respectively. No serious cases were noted. The authors concluded that where permitted by law, appropriately trained midlevel health care providers can provide safe medical abortion services for women independently from doctors. The results of the study further substantiate the safety and efficacy of MedabonR. The study was funded by the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) and Department of Reproductive Health and Research (RHR), World Health Organization
he article summary can be viewed here: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)62229-5/fulltext#article_upsell
Like many major organizations, Concept Foundation has recently been subject to the attention of a scam where people have received emails purporting to be from Concept Foundation inviting them to an International Meeting. Please do not respond to these emails nor contact any of Concept Foundation’s offices by phone or email. We do not send out general invitations to any International Meeting.