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. ...
Dear Healthcare Professional Janssen Pharmaceutica, the holder of the certificate of registration for Simponi 50 mg in agreement with the South African Health Products Regulatory Authority (SAHPRA) would like to inform you of the steps taken to reduce the risks associated with the administration of the...
This communication to industry refers to the Medical Device Unit and Radiation Control Unit publishing SAHPRA’s position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746....
The DHCPL is intended to inform healthcare professionals that Abbott Labs is experiencing a delay in production from the manufacturing site and anticipates shortages of Klacid XL in emerging markets....
Regulatory agencies on the African continent are beset by critical skill shortages caused in part by a lack of resources and training. While some of these issues are being addressed by the regulatory agencies themselves, there exists an urgent need for targeted training for clinical...
Please be informed that all documents and queries for GMP and CPP certificates should now be emailed to a new dedicated email address - see download. ...
To ensure continuity of supply of MeasBio for use in South Africa. Biovac obtained a Section 36 exemption from SAHPRA to supply the MeasBIO vaccine and the diluent for MeasBio packed in Indonesian National Agency for Food and Drug Control (NA-DFC) approved labelling with the...
We have in the past few weeks assisted several applicants that reached out to us, to retrieve old variations records attached to users that have been de-activated at an organisational level and we thought it best to issue this advice....
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of veterinary medicines. ...
Your attention is drawn to the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, making provision for the payment of retention fees to the Regulatory Authority in respect of medicines, medical devices and IVDs registered and site licences...