Guidelines

Download the following guidelines by clicking on the respective link

Quality 

1. SADC Guidance on submission of applications for Registration in CTD format: Quality
2. SADC Stability Guideline.

Bioequivalence, Safety and Efficacy

1. SADC Guidelines on Bioavailability / Bioequivalence

Biologics

1. Draft SADC Biosimilar Medicines: Quality, Non-Clinical and Clinical Requirements

Product Information and Labelling

1. Draft SADC Guideline on Product Information and Labelling

Human Medicines Post-Registration Guidance documents:

1. Draft SADC Guideline for submitting applications for variations to registered medicines

TEMPLATES

Quality Overall Summary (QOS) template