Regulatory Guidelines for Registration and Submission Criteria in South Africa (SAHPRA)

Document from the year 2022 in the subject Pharmacology, Andhra University (A. U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam), course: Pharmaceutical Regulatory Affairs, language: English, abstract: This publication examines the regulatory guidelines for registration and submission criteria in South Africa. South African Health Products Regulatory Authority (SAHPRA) is the entity of the national department of health (NDoH) launched in February 2017. It replaced the former Medicines Control Council (MCC) as well as Directorate of Radiation Control (DRC) that regulated medical devices in-vitro diagnostic tests and devices, radiation-emitting products and devices used in health care and industry. Due to several drawbacks of MCC such as becoming dependent on external expertise, it eventually lead to lack of effective performance management contracts and unsustainable mechanism for submission of evaluation reports, SAHPRA is established. An application for registration of medicines should be submitted for evaluation and approval through SAHPRA guidelines which are applicable to human medicines including biological and complimentary medicines. So SAHPRA adopted EU variation guidelines for quality and bio equivalence requirements for new registration and variations that are submitted by applicant in eCTD format established by the International Council for Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Submission of applications are done by following South Africa eCTD validation criteria in module 1 of regional information provided by South Africa.