Snapshot

The Accelerated registration of WHO-prequalified pharmaceutical products and vaccines pathway has been developed by the Philippine Food and Drug Administration (FDA) of Philippines.

This pathway can be used where This pathway is for World Health Organization (WHO)-prequalified pharmaceutical products and vaccines. In practice, FDA is adopting the WHO collaborative registration procedure as a registration pathway. The agency is asking companies that want to use the pathway to first ensure they have given WHO consent to share information with national regulators. The pathway is limited to products that are identical in quality and target the same indications as the ones covered by the WHO review. Applications filed under other facilitated review pathways, such as abridged review, cannot also benefit from the WHO procedure. Eligibility Criteria: 1. Only FDA-licensed drug manufacturers, traders, and distributors with WHO-prequalified vaccines or drug products may apply for registration through CRP. 2. Prior to the submission of the registration application with the FDA, the applicant shall ensure that the form provided under Appendix 2 of WHO TRS 996 Annex 8, Consent of WHO prequalification holder for WHO to share information with the national regulatory authority confidentially under the Procedure, has been duly accomplished and submitted by the Manufacturer or Prequalification Holder to the WHO/PQT. 3. The eligible product shall be the same as the product prequalified by the WHO/PQT. a. All aspects of the drug product’s quality, including but not limited to the formulation, manufacturing site/s, release and shelf-life specifications, and primary packaging, must be the same as those currently approved by the WHO/PQT at the time of submission. b. The proposed indication/s, dosing regimen/s, patient group/s, and/or direction/s for use should be the same as those approved by the WHO/PQT. 4. For post-approval changes (variations), only applications submitted to FDA not later than 30 calendar days after acceptance of the post-prequalification variations by WHO/PQT may be applied for variation application through CRP. 5. The applicant may choose to avail of the CRP only if the application has not been applied through other types of facilitated review pathway (i.e. abridged review and verification review). If the any of the requirements of CRP cannot be complied with, the application shall be processed following the regular review pathway..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from WHO

For Applications for New Drug Registration, the FDA shall inform the WHO/PQT and the applicant of its consent to apply the procedure through Appendix 3, Part B of WHO TRS 996 Annex 8, Decision on acceptance by the NRA to apply the Procedure to a specified WHO-prequalified product and request for access to product-specific information and documentation. Upon grant of access to the shared documents by WHO/PQT, the FDA is given a maximum of ninety (90) calendar days of regulatory time to evaluate the registration application using information provided by WHO, make a decision, and inform the applicant/importer. If, upon evaluation of the submitted documents, it is found that additional documents or further clarification is required to meet the appropriate standards for safety, quality, and efficacy, the applicant/importer shall be informed in writing. Regulatory time starts after a valid registration application following the CRP has been received and access to confidential information has been granted by WHO (whichever is later) and continues until the date of decision on the registration application. The regulatory time does not include the time granted to the applicant/importer to complete missing parts of the documentation, provide additional data or respond to queries raised by FDA. Within thirty (30) calendar days of issuing a regulatory decision to the applicant/importer, FDA shall inform WHO/PQT through Appendix 3, Part C of WHO TRS 996 Annex 8, Notification of outcomes of national registration procedure by the NRA. For Post-Approval Changes (Variation), the FDA shall inform the WHO/PQT and the applicant of its consent to apply the procedure through Appendix 3, Part B of WHO TRS 996 Annex 8. Upon grant of access to the shared documents by WHO/PQT, the FDA is given a maximum of thirty (30) calendar days of regulatory time to evaluate the registration application using information provided by WHO, make a decision, and inform the applicant/importer. If, upon evaluation of the submitted documents, it is found that additional documents or further clarification is required to meet the appropriate standards for safety, quality, and efficacy, the applicant/importer shall be informed in writing. Regulatory time starts after a valid registration application following the CRP has been received and access to confidential information has been granted by WHO (whichever is later) and continues until the date of decision on the registration application. The regulatory time does not include the time granted to the applicant/importer to complete missing parts of the documentation, provide additional data or respond to queries raised by FDA. If the evaluation of the application for post-approval changes results in the FDA-registered product being no longer the same as the WHO-prequalified product, or if a variation of the WHO-prequalified product is not followed by a variation of the FDA-registered product and, as a consequence, the FDA-registered product is no longer the same, FDA shall inform the WHO/PQT through Appendix 4 of the WHO TRS 996 Annex 8, Report on post-registration actions in respect of a product registered under the procedure the restricted-access website within thirty (30) calendar days of obtaining access to the information and documentation from WHO/PQT, to what extent the variation of the WHO-prequalified product is not followed.