As a way to encourage local production, the Egyptian Drug Authority (EDA) presented its technical consultation services to the local pharmaceutical industry. These are technical advice and support that companies can get from the agency on their prequalified products before starting the application process for final approval from the World Health Organization, in order to be able to export the approved products globally.
The EDA provides support for different parts of the application:
- Pharmaceutical Development,
- Quality of Summary (QOS),
- Risk Assessment of Nitrosamine Impurities.
IDRAC_350294_20-Jul-2022_Guidelines_ Technical Consultation for Getting CTD Approval from WHO (Prequ.pdf (303.2 KB)