Snapshot

The Registration of human medicinal products classified for fast-track process pathway has been developed by the of Malawi.

This pathway can be used where human medicinal 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 WHO

Target time assessment is There are three processes covered by the fast-track guidelines: 1. WHO PREQUALIFIED MEDICINAL PRODUCTS - Applicant should submit the product dossier for a WHO-prequalified pharmaceutical product to the Authority. The dossier submitted should be the same as submitted to the WHO-PQP during the initial prequalification procedure, and subsequent variation documentation where applicable; - The application should include; a) A completed application form for the registration of the product, including the same technical information as that submitted to WHO/PQP. The technical part of the dossier should be identical to the current version of the WHO/PQP dossier. b) The following country specific documentation; i) Executed batch manufacturing records of one production batch; ii) Where applicable, long-term stability studies protocol and report conducted at Zone IVB conditions. Copy of the current version of Quality Information Summary (QIS) submitted to the WHO. c) Pay the fast-track registration fees as per prescribed fee schedule. - In situations where the applicant wishes to apply the Procedure to an application which is already pending with the Authority, the applicant should first update the dossier to ensure that the technical part of the information is the same as that submitted to WHO. - Complete and submit an expression of interest form (Part A of Appendix 3) to the Authority through the WHO-PQ collaborative procedure focal person of the Authority. - The Authority shall communicate its consent to apply the procedure to the application for registration of the product and to request the WHO-PQ to share product specific information by completing and signing Part B of Appendix 3. - Applicant shall then complete and submit an expression of interest form (Part A of Appendix3) to WHO-PQP directing the PQP to provide full access to the information on the prequalified product to the Authority. - The Authority shall process the application and communicate its decision on the product to the applicant and WHO within 90 calendar days. 2. PUBLIC HEALTH MEDICINES - Submit full application as per the Authority’s requirement for the registration of medicines. - Pay the fast-track registration fees as per prescribed fee schedule. - Submit the required number of samples of the product as per the Authority’s sample guideline. - Fast-track registration shall only apply to medicines manufactured at sites that are good manufacturing practices (GMP) compliant with the Authority. - Products submitted through this route will be processed without following principle of first in first evaluated. The Authority will assess the application and communicate its decision on the product to the applicant within 180 calendar days. In cases where the applicant does not provide additional information in time as requested by the Authority, the 90-day timeline may be extended further. 3. SRA REGISTERED MEDICINES - All products with valid marketing authorization issued by SRA countries or region will be eligible for fast-track registration. This will include countries that were members of the ICH prior to 2015. - Applications for the registration of medicines under this category shall: (i) Submit full application as per the Authority’s requirement for the registration of medicines; (ii) Pay the fast-track registration fees as per prescribed fee schedule; (iii) Submit the required number of samples of the product as per the Authority’s sample guideline; (iv) Evidence that the product is registered in SRA country, evaluation reports by reference SRA country(ies) and responses by the applicant. The report from reference SRA need to be signed by response person at the reference SRA. - Products submitted through this route will be processed without following principle of first in first evaluated. The Authority will assess the application and communicate its decision on the product to the applicant within 90 calendar days. In cases where the applicant does not provide additional information in time as requested by the Authority, the 90-day timeline may be extended further. .