Rolling Submission Closure & CTD One Submission: What Companies Need to Know

The upcoming closure of the Rolling Submission pathway represents an important transition for pharmaceutical companies managing ongoing registration dossiers in Egypt.

Based on the recent webinar clarifications, companies now need to review their portfolios carefully and decide which products can still complete the current Rolling Submission pathway, which products will move to CTD One Submission, and which products require a formal Corrective Action Plan.

The transition is therefore not simply a change in submission format. It requires clear portfolio prioritization, timeline management, and product-by-product decision making.

1. The Key Deadline: 1 December 2026

To remain on the current Rolling Submission pathway, companies need to complete three key actions before 1 December 2026.

All pending technical studies should be completed, outstanding responses and departmental requirements should be finalized, and the Final Hard File should be submitted before the deadline. Rolling submission closure-MODR…

After 1 December 2026, departments will no longer continue files under the Rolling Submission pathway. Any dossier for which the Final Hard File has not been submitted will move to One Submission. Rolling submission closure-MODR…

This makes the coming weeks particularly important for companies with products that are already advanced in technical assessment and may still be able to complete the current pathway.

2. What Happens to Existing Dossiers After 1 December?

The transition to One Submission does not necessarily mean that every dossier will restart from zero.

The way each product will be handled depends on the stage already reached before the transition.

If a Technical Approval has already been issued, the approved part remains valid and does not undergo a completely new assessment. However, the full study is still submitted together with the previously issued approval.

If the dossier is Under Assessment, it moves to One Submission while taking into account the stage already reached and the requirements that have already been evaluated.

If a Round of Comments has already been issued, the company continues responding to the existing comments rather than restarting the assessment from the beginning.

For products where studies or the dossier have not yet been submitted, the product will enter the CTD One Submission pathway and be evaluated under the new system. Rolling submission closure-MODR…

3. One Assessment Outcome, One Unified Letter

Under the clarified process, individual departments continue evaluating their respective sections, but their comments are consolidated into a Unified Letter issued to the company.

The regulatory interface becomes more centralized through the Regulatory Affairs Administration, with Dr. Yasmine Hesham identified in the webinar minutes as the relevant point of contact. Rolling submission closure-MODR…

The session also indicated that companies may explore a Fast Track route where applicable and in accordance with the relevant requirements. The webinar brief notes an associated service fee of approximately EGP 205,000. Rolling submission closure-MODR…

4. The 33-Month Registration Timeline

Another major update comes from the Technical Committee decision dated 17 September 2026.

The previously granted 18-month period has been extended to a maximum of 33 months, running from 17 September 2026 until 17 June 2029. Rolling submission closure-MODR…

This period includes any previous extensions already granted to the product and applies to completion of registration procedures and submission of the final registration dossier through One Submission. Rolling submission closure-MODR…

The products highlighted in the webinar include those falling under Decision 425/2015, relevant cases under Decision 645/2018, and products with preliminary registration notifications covered by the implementation mechanism issued on 2 April 2026. Rolling submission closure-MODR…

5. Corrective Action Plan: Deadline 17 December 2026

Companies covered by the decision are required to submit a Corrective Action Plan no later than 17 December 2026.

The plan should clearly define which products the company intends to continue, which products it intends to cancel or discontinue, and the timeline for completing each continuing product.

For products that will continue, the timeline should be divided into Milestones every six months, allowing progress to be monitored throughout the remaining registration period. Follow-up reports are also expected every six months. Rolling submission closure-MODR…

This makes the Corrective Action Plan more than an administrative requirement. It becomes a formal portfolio commitment.

6. Voluntary Cancellation Does Not Necessarily End the Opportunity

Companies may also decide that continuing some products is no longer commercially or strategically justified.

If a product is voluntarily cancelled as part of the Corrective Action Plan, the company may later apply to register it again under Decision 450/2023.

The webinar summary also indicates that the company may be able to retain its position in the similar-products box, subject to Technical Committee review and assessment of factors such as market need. Rolling submission closure-MODR…

This means cancellation should not automatically be viewed as failure. In some cases, it may be a rational portfolio decision that allows resources to be redirected toward products with stronger registration or commercial priorities.

7. What Happens If the Company Does Not Follow the Plan?

The Corrective Action Plan comes with clear compliance expectations.

A product may be presented to the Technical Committee for cancellation if the company fails to submit the Corrective Action Plan by the deadline, does not follow the submitted timeline, fails to meet the defined milestones, or does not complete registration before 17 June 2029. Rolling submission closure-MODR…

Progress will be reviewed every six months, making continuous follow-up essential.

For Regulatory Affairs teams, this creates a new level of portfolio accountability: every product needs a defined next step, deadline, and responsible action.

8. Products with Pricing-Related Timelines

The webinar also addressed products where the registration timeline is linked to the date of pricing approval.

For products whose pricing validity expired before September 2026, or will expire during the 33-month period, the webinar minutes indicate that an extension fee of EGP 5,000 per month may apply for the months required to reach the end of the 33-month period. Rolling submission closure-MODR…

For example, if a pricing validity period ends on 17 June 2028, there would be 12 months remaining until 17 June 2029, corresponding to an extension amount of EGP 60,000 under the mechanism described in the session. Rolling submission closure-MODR…

However, the brief itself recommends confirming this extension fee and its exact calculation with the relevant authority before final reliance. Rolling submission closure-MODR…

9. How Companies Should Review Their Portfolio Now

The practical priority is to divide the portfolio according to the current registration status.

Products for which studies have already been submitted and which are sufficiently advanced should be reviewed urgently to determine whether all technical requirements can be completed and the Final Hard File submitted before 1 December 2026.

If this can be achieved, the product may remain within the Rolling Submission pathway.

For products that have not yet been produced, are still at an early stage of technical studies, or cannot realistically complete the current process before the closure date, companies should prepare the Corrective Action Plan before 17 December 2026 and define a realistic timeline with six-month milestones. Rolling submission closure-MODR…

At the same time, companies should identify products that are no longer worth continuing and consider placing them on the cancellation list rather than carrying them indefinitely within the portfolio.

10. Special Review for Products Under Decisions 425 and 645

Products under Decision 425 and the relevant third and fourth cases under Decision 645 should be reviewed further according to their pricing status.

Products whose pricing has not yet been signed should be assessed to determine whether they can complete the required studies and Final Hard File before the Rolling Submission closure, or whether they should move into the Corrective Action Plan and One Submission pathway.

For products whose pricing has already been signed, companies should review the pricing date, validity period, expiry date, remaining period until 17 June 2029, and any potential extension fees that may apply. Rolling submission closure-MODR…

What Does This Mean for Regulatory Teams?

The most important message is that companies should not treat the Rolling Submission closure as one general regulatory deadline.

Every product may now require a different decision.

Some products should be accelerated before 1 December 2026.

Others should move into a structured Corrective Action Plan before 17 December 2026.

Some may need to transition into One Submission, while others may be better candidates for voluntary cancellation.

The right approach is therefore:

Review the Portfolio → Assess Each Product → Decide the Pathway → Set the Timeline → Monitor the Milestones

The transition to CTD One Submission is ultimately not only about dossier structure.

It is about building a more disciplined approach to regulatory portfolio management, prioritization and lifecycle planning.

At MODREG, we believe regulatory changes become truly useful when they are translated into clear actions, timelines and portfolio decisions.