Country Support

Our Country Support team works with in-country stakeholders to facilitate access to quality-assured sexual and reproductive health (SRH) medicines and technologies in low- and middle-income countries (LMIC).

We support pharmaceutical manufacturers to register quality-assured essential medicines, identify procurement pathways and ensure that SRH needs are reflected in local policies, guidelines and essential medicines lists (EMLs).

Photo Credit: Joni Kabana

Country Support

Our Country Support team works with in-country stakeholders to facilitate access to quality-assured sexual and reproductive health (SRH) medicines and technologies in low- and middle-income countries (LMIC).

We support pharmaceutical manufacturers to register quality-assured essential medicines, identify procurement pathways and ensure that SRH needs are reflected in local policies, guidelines and essential medicines lists (EMLs).

Photo Credit: Joni Kabana

 Registration of SRH medicines

  • We provide regulatory support to manufacturers with the goal of registering and supplying their SRH medicines and technologies in LMIC settings
  • We register SRH medicines on behalf of generic and innovator manufacturers in LMIC markets
  • We develop regulatory strategies with manufacturers of SRH medicines and technologies with a focus on LMIC markets

 

Market Access Activities

  • We work with international and national stakeholders to support the introduction of medicines for safe medical abortion, maternal health and contraception in LMIC markets
  • We support the development of comprehensive national and regional strategies to strengthen systems for SRH medicines procurement, with a focus on central Asia and Africa
  • We work with international, regional and national stakeholders to develop and update guidelines, EMLs and procurement manuals for SRH medicines

OUR CURRENT FOCUS

STRENGTHENING NATIONAL AND REGIONAL POLICIES AND GUIDELINES

As part of several ongoing projects, Concept Foundation is working with partners to develop comprehensive national and regional strategies to strengthen systems for SRH medicines procurement, update guidelines, EMLs and policies to support the introduction of drugs for medical abortion, and maternal health drugs in Central Asia and Africa.

In parallel with Concept Foundation’s ongoing efforts to reduce Post-Partum Haemorrhage (PPH) in LMICs, we are supporting the update of guidelines and EMLs to improve access to quality-assured and affordable, preventive and therapeutic PPH medicines across the African Region.

In 2020, engagement activities by Concept Foundation and its regional partners have resulted in a number of countries within Africa’s Regional Economic Communities responding positively to the initiative and are working toward the update of their PPH guidelines and EMLs to reflect the most recent WHO recommendations. The project has now been completed, and Concept Foundation is following up with clinical protocol development at global and local levels for countries where guideline and EML inclusion have been achieved. In a subset of selected countries, Concept Foundation will conduct pilot protocol implementation projects and continue to work with regional partners to advocate for the inclusion of essential maternal health commodities in the Essential Package of Health Services as a step towards UHC in regions with significant PPH burden.

SELF-CARE REGULATORY STANDARDS AND PROCESSES OF SRH PRODUCTS 

With funding from WHO we are undertaking research and reporting on the regulatory situation and availability of self-care products with a focus on contraceptives, emergency contraception and selected fertility products. A 3-month pilot project started with five countries from the Eastern Mediterranean Region (Egypt, Jordan, Morocco, Lebanon and Tunisia). The second project started late 2020, and includes 25 counties from the remaining five WHO regions; Africa, Americas, Europe, South East Asia, and Western Pacific. In this project, the scope of products expanded to include diagnostic tests (pregnancy, ovulation & HPV) in selected countries.

Click here for more information on the self care project

Self-care and remote care during pregnancy: a new paradigm?

REGISTRATION OF AN INNOVATOR UTEROTONIC IN LMIC

Concept Foundation’s regulatory team is currently supporting the manufacturer of an innovator uterotonic to register the product in over 90 LMIC, including identifying the optimal regulatory pathway in each country, on a country by country basis, and submitting the regulatory dossier in-country on behalf of the company.

REGULATORY GUIDANCE ON OXYTOCIN STORAGE CONDITIONS TO NMRAs

Concept Foundation is working with WHO to develop guidance for national medicines regulatory authorities (NMRAs) and oxytocin manufacturers to implement a policy of requiring cold storage and transport. 

 

OUR IMPACT AT THE COUNTRY LEVEL 

Since its creation in 1989, Concept Foundation has been working to introduce essential SRH medicines and technologies in LMIC through public-private partnerships and other market access programmes.

While quality-assured medicines are available globally, LMIC markets are often not financially attractive enough for manufacturers to register their products in high need markets. In some countries, introduction of essential medicines is slowed due to a lack of resources available to update and implement new guidelines and policies. The situation is particularly difficult when we consider abortion commodities. CF works to address these challenges through the provision of regulatory support and engaging with key stakeholders at the country level, or through its international networks.

Concept Foundation supported the registration and introduction of Medabon, the first quality-assured medical abortion combipack in 27 countries, with several more in process in Southern Africa and Central Asia. We have supported China Resources Zizhu Pharmaceutical Co. Ltd. to achieve WHO prequalification of several of their SRH products and continue to support its registration activities in Africa.