Snapshot

The Import of New Drugs pathway has been developed by the of Macao.

This pathway can be used where The approval pathway for pharmaceutical products comprising new active pharmaceutical ingredients is overseen by the Macao Pharmaceutical Regulatory Authority (Instituto para a Supervisão e Administração Farmacêutica, ISAF). It adopts a high level of regulatory recognition of decisions made by selected national regulatory agencies (Mainland China, Australia, Canada, the European Union, the United States, Japan, the United Kingdom, and Switzerland). This pathway allows Macau residents timely access to novel pharmaceutical products..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

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

The approval timeline for pharmaceutical (Western medicine) registration varies on a case-by-case basis. Generally, within five months from the date of complete dossier submission, the application will be submitted to the Technical Committee for Drug Registration for technical review. Depending on the Committee’s assessment findings, the ISAF will notify the applicant of the evaluation outcome or request supplementary revisions to the application or additional documentation for further assessment.