Customer Requirement: Women’s health and fertility are vital aspects of their overall well-being, and yet they often remain shrouded in silence and misconception. Every woman has the right to access healthcare, irrespective of their socioeconomic background or geographical location, though many women face significant challenges and barriers that restricts their access to the medications they need for their health and well-being. A female health NGO had developed a contraceptive implant that could provide contraception for a minimum period of 3.5 years. The organization also had a number of other contraceptives such as IUDs, depo-injections which were again in space of contraception. Another NGO in the female reproduction category had developed medications to prevent post-partum blood loss as well as termination of unwanted pregnancies. The intent of these organizations was to maximize the access of female health medication to women in least developed and developing economies of the world, advocating the advantages of the contraception and exercising choice of having pregnancy at a more appropriate time. The advocacy was focused primarily to women of lower socio-economic strata, in Africa, Latin America, South and South East Asia, and CIS However, the challenge remained to gain wider market access for these products using common data pool.
Key Objective: To find a way to achieve rapid access to contraceptive implant/devices and other woman health medications, through regulatory intervention, so as to ensure wider access to safe, efficacious, and high-quality medication, to women in developing countries.
DDReg Solutions and Processes Adopted: The regulatory team working for developing markets got together to devise a strategy on how to obtain license/MAs in a faster manner in the countries of these developing markets. The group decided to take the WHO Prequalification (WHO PQ) pathway route which is a stringent procedure requiring a very complex and detailed documentation, a site audit followed by meticulous pre-qualification procedure. The regulatory team at DDReg worked diligently to prepare and compile the dossier for submission and responded to queries by the assessor. As a result the WHO PQ was granted on all occasions that helped the Woman Health products to gain MAs in countries of interest, thus assuring success of advocacy programs.
Business Impact on DDReg: DDReg successfully brought female products to the desired market regions of the NGO and has established a relationship of almost 10 years of working in the area of Women Health. The organization has achieved its credibility and is renowned for its work in support timely access to crucial female health products.