About the Accelerated Preclearance Pathway (APP)

APP will complement the existing preclearance pathway. When launched (date TBD), APP will initially be available for a subset of submission types. Over time, APP will cover all applicable submission types. This gradual increase will provide PAAB the opportunity to scale staff, technology, policies and procedures, ensuring you receive a consistent high level service.

Welcome to the APP

The proposed new service is intended to reduce the time to approval through five separate but synergistic mechanisms.The 5 points, along with pricing, as noted below are still being finalised.

​Quicker response time for initial review

You can choose from 2, 4, or 7 business days depending on your budget and urgency.

Quicker response time for subsequent revisions

Response within 2 business days

What do you mean by "decoupling of submission elements"? The ability to obtain official rulings for select parts of an ongoing submission rather than needing to wait to resubmit the entire revised copydeck/layout. These decoupled interim rulings are provisional only on the final context. This means that these interim rulings can be considered firm so long as revisions made in the context of the decoupled elements, upon resubmission of the revised entire copydeck/layout, do not render the ruling inapplicable.

What do you mean by "asynchronous messaging"? This refers to a virtual conversation in which the conversing parties are not required to be concurrently active or present.

Decoupling of submission elements for additional collaboration through asynchronous messaging with your reviewer.

A. Via a messaging functionality directly on your submission, you’ll be able to obtain a provisional ruling for select parts of an ongoing submission. This removes the need to wait and resubmit your entire revised copy deck/layout and resubmission letter.
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B. These decoupled interim rulings are provisional only on the final context. This means that these interim rulings can be considered firm so long as revisions made, are acceptable in the context of the other decoupled elements and vice versa.

Submission

These images are an example of a post-gate homepage of a fictional prescription product Verant. It would form part of the initial submission of the website submitted to PAAB for review.

1st Review

PAAB reviewer, Nikki, provides comments for the client. She is precisely clear which phrase, word, image element, or syllable EACH revision/clarification request pertains to. The comments are always in context.

Client Q

Hosea, the client, is able to respond to Nikki’s comments with suggestions in both text and visual form for Nikki to review

PAAB Answer

Within 24 hours (on business days), the reviewer responds that the proposed revisions would not address the issue. Nikki proposes a solution that builds on Hosea’s attempt to address the issue.

Client Q2

Hosea agrees to the suggestion and sends the reviewer an updated description of how to resolve the issue. This is what the Reviewer sees:

PAAB Answer 2

The reviewer responds again within 24hrs (on business days). She confirms that the proposed fix is acceptable.

(These rulings on client selected elements of the submission will be provided over an asynchronous messaging functionality which will be integrated directly into copydecks, layouts, and video on the eFiles submissions system.  PAAB will respond over this system within 24 hours (on business days). Implementation of this functionality does not prevent clients from engaging with reviewers over the phone in a scheduled live discussion. )

Access a second opinion from another reviewer in your therapeutic area.

​To help you check that a ruling is both accurate and consistent early in your review process,  you can now request a second opinion after the second PAAB correspondence on that particular matter.

(This service will only be available as part of the APP, as it utilizes new messaging functionality embedded directly onto the submission. A second opinion may be requested in a client correspondence explaining why they disagree with the reviewer's position after the second PAAB correspondence on that particular matter. As each communication over the messenger counts as a "correspondence", the second opinion is available very early in the review process.)

Earlier access to the escalation process with the Senior Reviewer of Preclearance Services.

​As your communications over the messenger counts as a "correspondence", the escalation becomes available to you very early in the review.

(Escalations will continue to take place over the telephone (or web-conferencing). Escalation must be requested in a correspondence explaining why the client disagrees with the second opinion. As each communication over the messenger counts as a "correspondence", the escalation becomes available to the client very early in the review (in contrast to the standard preclearance pathway where only written letters are available as official correspondences).

PAAB’s current and proposed offerings

Accelerated Preclearance Pathway (new)*

	Current	APP 7	APP 4	APP 2
Cost single language	$390	$585	$780	$1170
Cost multi language	$450	$675	$900	$1350
1st response	10 days	7	4	2
Subsequent response time	3 days	2 days	2 days	2 days
Decoupling submission elements	No	Yes	Yes	Yes
2nd opinion	No	Yes	Yes	Yes
Escalation timing	Determined by # of written correspondence	Determined by # of comms over messenger	Determined by # of comms over messenger	Determined by # of comms over messenger

​*pricing and service features may change ahead of the launch.

Comments or questions?

If you'd like to comment on the APP. Please email PAAB on [email protected] ​