Guidelines on Submission of Documentation for Registration of Human Pharmaceutical Products

"These guidelines were compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community Medicine Regulatory Harmonization (EAC MRH) project. They relied on the registration requirements of their countries, the World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements for Registration of Medicines for Human Use (ICH). The guidelines were developed to provide direction to the ministry of health in managing applications for registration of human pharmaceutical products in Rwanda"