Snapshot

The Reliance pathway for post-approval changes to a registered biotherapeutic product pathway has been developed by the of Egypt.

This pathway can be used where This reliance pathway brings benefits to patients, industry, and government by facilitating and accelerating access to quality-assured, effective, and safe medicinal products while saving resources and reducing duplication of regulatory efforts. In this context, reliance for post-approval changes (PAC) is applied on products approved from reference countries. To ensure continuous harmonization between the reference country dossier and the EDA dossier, PACs approved by the reference authority need to be submitted regularly to EDA. Reliance is applicable on: (i) Quality changes, and (ii) Product labelling information changes. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Austria Belgium Canada Denmark Finland France Germany Iceland Ireland Italy Japan Luxembourg Netherlands New Zealand Norway Portugal Spain Sweden Switzerland United Kingdom United States

1. Submission Phase: Marketing Authorization Holders (MAH) request an appointment for submission of PAC by sending an email to bioreg.variation@edaegypt.gov.eg with the variation application form. The MAH shall receive an appointment within 3 working days (WDs) in order to upload the file. On the predefined appointment, the MAH submits the variation package on the electronic portal. 2. Verification Phase: In this phase, the submitted documentation is checked versus the reliance checklist to verify that the mandatory documents are attached. The MAH shall receive an e-mail within 5 WDs showing the submission status. Note that the absence of any of these documents hinders the acceptance of the submission. Whenever additional documents are required during the verification phase, the MAH is granted a 20 WDs grace period to submit/provide them. 3. Decision Phase: It is considered the final phase in handling PAC, where one of the following outcomes is expected: (a) If EDA determines that the information submitted supports the quality, safety, and efficacy of the post-changed product, the EDA will issue a written approval letter. Note: A written conditional approval letter may be issued in certain cases, for example: re-analysis or the requirement of specific documentation that doesn’t hinder approval. Upon fulfilment of the condition, the MAH shall receive a notification email that the condition is fulfilled. (b) If EDA determines that the information submitted fails to support the quality, safety, or efficacy of the product manufactured with the change, a written disapproval letter will be issued to the MAH. Timelines: 1. Quality Changes. Major quality changes = 15 WD Moderate quality changes = 10 WD 2. Labelling update Change. Product labelling information changes = 10 WD *These timelines are calculated from the date of receiving the variation file excluding the time granted for the MAH to fulfil any complementary document. Implementation of PAC: 1. The anticipated date for the implementation of the change should be indicated in the submission of the PAC (if applicable). 2. Labelling changes that include safety and efficacy changes or product labelling information changes should be implemented within 6 months of the EDA approval date. 3. Outer/inner packs update could be implemented within 12 months of the EDA approval date.