Archive
25 Jan General Information Guideline
Posted at 10:01h
in
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality and efficacy of medicines. It is not intended as an exclusive...
25 Jan Industry Communication on Interim Measures Pending Update of Variation Addendum
Posted at 09:58h
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2020 Sep...
24 Jan Biological Medicines Amendment Guideline
Posted at 12:51h
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This guideline document is intended to provide recommendations to applicants wishing to submit applications for the registration of biosimilar medicines. It represents the South African Health Product Regulatory Authority’s (SAHPRA) current thinking on the safety, quality, and efficacy of medicines. It is not intended as...
24 Jan Biological medicines stability Guideline
Posted at 12:49h
in
This guideline is intended to give guidance to applicants regarding the type of stability that should be provided in support of the shelf-life of the biological medicines. It represents SAHPRA current thinking on the safety, quality and efficacy of the biological medicines. This guideline is...
24 Jan Guideline for Pre-Registration Consultation Meeting
Posted at 12:47h
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This document provides guidance on the procedures involved in the scheduling and conduct of Pre-Registration Consultation meetings between the Office of the Chief Regulatory Authority (CRO) of the South African Health Product Regulatory Authority (SAHPRA), and the applicant / sponsor for biological medicines. The primary...
24 Jan Scheduling of substances for prescribing by authorised prescribers other than medical practitioners or dentists
Posted at 12:46h
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This document provides guidance on the process for amending the Schedules to the Medicines and Related Substances Act, 101 of 1965 (Medicines Act) to allow prescription rights to authorised healthcare professionals, other than medical practitioners or dentists, in accordance with the provisions of section 22A...
24 Jan Guideline to the scheduling of substances and medicines
Posted at 12:44h
in
This guideline is intended to provide guidance to applicants on the scheduling of substances submitted for registration as medicines. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and takes into account the country’s obligations...
24 Jan Biosimilar Medicine Quality, Non-clinical and Clinical Requirements
Posted at 12:40h
in
This guideline document is intended to provide recommendations to applicants wishing to submit applications for the registration of Biosimilar Medicines. It represents the South African Health Product Regulatory Authority’s (SAHPRA) current thinking on the safety, quality, and efficacy of medicines. It is not intended as...
24 Jan Guideline for proprietary names for medicines
Posted at 12:39h
in
This document provides guidance to applicants regarding the acceptability of proposed proprietary names of products submitted for registration as medicines. It represents the current thinking of the South African Health Products Regulatory Authority on the naming policy, how the naming policy is intended to inform...