Snapshot

The Abridged Review pathway has been developed by the National Directorate of Pharmacy in the Mozambique Ministry of Health of Mozambique.

This pathway can be used where new chemical entity; generics; biologicals; medical devices; blood 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 Brazil Canada China EU-EMA Japan Mexico Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States WHO Zazibona

Target time assessment is The average time for granting a marketing authorization for a product, counted from the date of receipt of a valid application, i.e. assessed in a single round without the request for additional information, is as follows: • Full Procedure – 365 days • Abridged Procedure – 270 days • Collaborative Procedure (WHO) and by Recognition – 90 days; • SADC ZAZIBONA Collaborative Procedure for products not yet approved – 360 days For expedited applications, as defined by the Resolution on the Prioritisation of Marketing Authorisation for Medicines in Mozambique, the average time for granting a marketing authorisation is 130 days and 60 days for post-registration applications. The timeframes set out above are suspended whenever the applicant is required to rectify deficiencies or provide additional information, with the count restarting upon receipt of the missing elements.