Snapshot

The Evaluation Route 1 (Multi-Source Well-Established Products) pathway has been developed by the of Papua New Guinea.

This pathway can be used where Sub-Route 1 A: - Medicines of multi-source well established products, and - Having a WHO-Type certificate with approved product information. - The product is already included in WHO Prequalification list, then, the evaluation process can rely on WHO Prequalification decision with adjustment on the product information and labeling, if needed. Sub-Route 1 B: - Medicines of multi-source well established products, - The product is not yet included in WHO Prequalification list, then, evaluation is done whether it is identical to the one approved in the exporting country. If it is identical, then, evaluation can rely on the exporting country’s data with adjustment on the product information and labeling, if needed. - If it is different, whether the differences are acceptable. Assessment needs to be done on the minimal requirement emphasizing on the quality consistency and acceptable product information and labeling. - Having a WHO-Type certificate with approved product information. .

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

When relevant, the agency relies on prior decisions from Australia Canada Europe Japan New Zealand Singapore United Kingdom United States

Target time assessment is The submitted application will be screened and validated for completeness within five (5) working days. Application must be duly completed and submitted with the required documents. Applications which are incomplete will not be accepted and applicants will be notified. Upon acceptance of an application, an Acknowledgement Letter for the receipt of the application will be issued and a Reference Number will be generated. The reference number shown in this acknowledgement letter should be used in all subsequent correspondences relating to the application. Acknowledgement of the medicine registration application does not mean that the data provided is acceptable. Acceptability of data can only be determined during the evaluation process. Review of application for registration of a product will follow the appropriate or standard evaluation queue. This means each registration application will go through the evaluation process within 60 working days before a regulatory decision can be made available to marketing authorization applicant unless the applicant is advised accordingly by NDoH. .