Snapshot

The NDA Abridged Evaluation Process pathway has been developed by the Uganda National Drug Authority (NDA) of Uganda.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from ASEAN Algeria Argentina Armenia Australia Azerbaijan Brazil Canada China Colombia Cuba EU-EMA East African Community (EAC) Egypt GHC-GCC Iceland India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Liechtenstein Malaysia Mexico Moldova, Republic of Norway Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Turkey Ukraine United Kingdom United States Zazibona

"Regulatory decision on products already authorized for marketing by SRA and those approved under Article 58 of EU Regulations = 120 days Regulatory decision on MA for WHO Prequalified products = 90 days"