Snapshot

The Abridged Review pathway has been developed by the Medicines Control Agency (MCA) - Gambia of The Gambia.

This pathway can be used where All products.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The Agency shall acknowledge receipt of all applications and payment of fees at submission. The Agency shall process an abridged review application within 90 days (compared to 180 days for a normal application for registration of a medicine). The Agency may consider an abridged review for medicines prequalified by WHO or, on a case-by-case basis, for medicines authorised by Regulatory Authorities (RA) recognised by MCA. For registration of medicines in public health emergencies the MCA Gambia shall decide on the timeline on a case-by-case basis.