24 Jan Guideline for Pre-Registration Consultation Meeting
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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 purpose of the meetings is to address issues relating to the development of biological medicines in the planning phase of such products.
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Document Number:
SAHPGL-PEM-BIO-03
Version:
2
Date Updated:
13/09/2022
File Type:
pdf
Category:
Guideline