Guideline for Pre-Registration Consultation Meeting

Guideline for Pre-Registration Consultation Meeting

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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Date updated

2022 Sep

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File Type: pdf
Category: Guideline
Unit: Biological Medicines Evaluation and Research