An Assessment of Global Chemistry, Manufacturing and Controls Regulatory Requirements in Low and Middle Income Countries

The new Director General of the World Health Organization has stated that one of his top priorities is "Health for all" saying that "ensuring universal health coverage without impoverishment is the foundation for achieving the health objectives of the Sustainable Development Goals - because when people are healthy, their families, communities, and countries benefit." [...]for many of these markets, products are purchased by national or international procurement agencies, which not infrequently have their own requirements that affect the manufacturing and packaging of these products. Currently there is no single publicly available repository that comprehensively captures the registration and CMC requirements of LMICs. [...]the regulatory teams within manufacturers undertake the time-consuming task of locating and interpreting LMIC's requirements for each country in which they want to introduce their products. Particularly, the requirement for a large number of samples with sufficient product shelf life for testing at registration can be costly if not planned ahead of time. * Prior NRA Marketing Authorization - The requirement for a Certificate of Pharmaceutical Product (CPP) for many LMICs, which generally has to be notarized or apostilled can add significant time and complexity to product introduction and maintenance of marketing authorization throughout the lifetime of the product. * Reference Product Selection - Some countries have specific requirements regarding the use of local comparators for bioequivalence studies, where the study should be conducted or which international comparator would be accepted.