Medicines regulation remains an important but neglected component of promotion and protection of public health because it helps to ensure that patients have access to quality, safe, and efficacious medicines. Investing in the African Medicines Regulatory Harmonization (AMRH) initiative provides an opportunity for strengthening regulatory capacity, cost-effective use of the limited financial and human resources, attainment of the three health-related Millennium Development Goals (MDGs), and promotion of trade and socioeconomic development for African countries and regions.