African Medicines Regulatory Harmonisation (AMRH) - Evaluation of Medicinal Products Technical Committee (EMP-TC) - APPLICANT’S HANDBOOK

In addition, the checklist will facilitate the demonstration of the eligibility of the medicinal product for the EMP TC procedure. [...] The Integrated Overview and Conclusions should clearly define the characteristics of the human pharmaceutical as demonstrated by the nonclinical studies and arrive at logical, well-argued conclusions supporting the safety of the product for the intended clinical use. [...] S.2.2 Description of manufacturing process and process controls The description of the API manufacturing process represents the applicant’s commitment for the manufacture of the API. [...] Elucidation of structure The MA application should include quality assurance (QA) certified copies of the spectra, peak assignments and a detailed interpretation of the data of the studies performed to elucidate and/or confirm the structure of the API. [...] The identity of the isomeric composition of the API to that of the API in the comparator product should be established.