Snapshot

The Priority Review Pathway pathway has been developed by the of Papua New Guinea.

This pathway can be used where Priority Review may be granted if the medicines meet the following criteria: 1. It is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address local unmet medical needs, as defined by: i. the absence of a treatment option; or ii. the lack of safe and effective alternative treatments, such that the medicines would be a significant improvement compared to available marketed products, as demonstrated by: (a) evidence of increased effectiveness in treatment, prevention, or diagnosis; or (b) elimination or a substantial reduction of a treatment-limiting drug reaction. 2. Disease conditions that are of local public health concern will be given primary consideration for priority review. Currently these include: i. Cancer; and ii. Infectious diseases such as dengue, tuberculosis, hepatitis and malaria. .

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. Priority review will be conducted within 30 working days unless the marketing authorization applicant is advised accordingly. The request for Priority Review should be made at the point of the application submission by indicating it on the Application Form and accompanied by substantiated justifications. This pathway will accelerate the two pathways offered by the regulatory authority, i.e. Evaluation Route 1 (Multi-Source Well-Established Products) and Evaluation Route 2 (NCEs & Complex Biologicals). The National Department of Health reserves the right to deny a request for priority review if it is deemed appropriate. The decision for the granting of priority review would be conveyed to the applicant at the point of acceptance of the application for evaluation. .