COVID-19 Clinical Trials - Two-Weekly Progress Reports Pilot – Clinical Trial Applications...
As you may be aware, SAHPRA has embarked on a process to digitalise its business processes. A pilot electronic process is planned for new medicinal clinical trial applications for January 2024. The official launch of the system for all new medicinal clinical trial applications will...
This communication is for Stakeholders to be aware of the South African Health Products Regulatory Authority (SAHPRA) Clinical Trials Committee meeting dates and the submission dates for the year of 2024. ...
This guideline is intended to provide guidance to applicants regarding applications for registering co-packaged medicines. It represents the South African Health Products Regulatory Authority (SAHPRA) current thinking on co-packaging of medicines. SAHPRA reserves the right to request any additional information to establish the safety,...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines....
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (categories A and D) containing specific substances. With respect to Category D medicines, the guidance provided herein is related to general content requirements. Any specific technical...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (categories A and D) containing specified substances. With respect to Category D medicines, the guidance provided herein is related to general content requirements. Any specific...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality, and efficacy of a...