Snapshot

The Abridged Review pathway has been developed by the Ghana FDA of Ghana.

This pathway can be used where Review is applied on the pre-requisite that the product has been previously approved by a stringent regulatory authority such as the United States Food and Drug Administration (US FDA), United Kingdom Medicines and Healthcare products Regulatory Agency (UK MHRA), Health Canada or those reviewed by the European Medicines Agency (EMA) centralised registration procedures. An abridged assessment is carried out in relation to the benefit-risk assessment of the product under local conditions. In these reviews, the dosage form, strength, ingredients, indications, dosage, warnings and precautions must be identical to the authorised product, including the manufacturing site/lines and a complete dossier in the CTD format, including identical data for all modules must be submitted. Within the abridged review category, there is a consideration for an additional priority/fast track review application when the need for rapid assessment is required for patients’ access to medicines. An application is classified as priority and may be expedited if the product is for any of the following; public health programmes (including HIV/AIDS, malaria, tuberculosis, reproductive health, neglected tropical diseases or an expanded programme of immunisation), paediatrics, Ministry of Health tender purposes, WHO prequalification collaborative registration process and any other disease or conditions as may be determined by the FDA from time to time). The timeline for processing priority applications is three months. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Canada EU-EMA United Kingdom United States

266 calendar days. (This includes both the agency and the industry response time, as per the FDA Ghana website.)