December 21, 2023

The Evolving Global Regulatory Landscape: Looking Forward with Calyx’s Regulatory Consultants

As we enter 2024 , Calyx’s Regulatory Information Management Consultants provide their insights on what to expect and what they’re looking forward to as the global regulatory landscape continues to evolve in the new year.

AliceMerrill

Alice Merrill, RIM Consultant

I am excited to see the EMA release Nationally Authorised Products and IDMP-compliant Centrally Authorised Products for use in electronic Application Forms.

The eAF is the first time the EMA have implemented IDMP in their processes: it’s been really interesting to see how they have adapted the product information they hold internally and in xEVMPD for use in the IDMP-compliant Product Lifecycle Management portal. The challenges that they’ve faced, and the solutions they’ve found, will also be useful guidance as pharmaceutical companies develop their own processes for collecting and managing IDMP data.

Currently, the EMA say that they expect to release NAP and split CAP product data in Q1 of 2024, but we have seen this date move several times now as they have tackled issues with the structure of the product data.

More information about the eAFs and related projects can be found on the EMA’s PLM Portal and on the eSubmission site.

DiarmuidWaide

Diarmuid Waide, Sr. RIM Consultant

As I specialise in publishing, I’m most excited for the increase of eCTD v4.0 submissions in 2024.

The enhanced functionality especially when it comes to being able to re-use documents from a different application is a game changer. This will make submission of groupings/work-sharings significantly easier and decrease the time needed to publish.

I am really happy to see the new context of use features of eCTD v4.0. This will drastically improve continuity in the life cycling of documents. Changing keyword values without resubmitting documents is something I would love to see used. It will really help clean up Module 3 in particular, which can become a complex nest of folders very quickly when manufacturers change or new dosage forms/dosages are added!

With all the new features included in eCTD v4.0 it’s exciting to see how sponsors will use the tools to enhance their dossier quality and publishing efficiency.

More information on eCTD 4.0 technical specifications and implementation can be found on the ICH’s official eCTD v4.0 site.

ShilpaTikare

Shilpa Tikare, Sr. RIM Consultant

I’m interested to see further international use of the eCTD submission standards. The Economic Community of West African States (ECOWAS) started accepting submissions in eCTD for centralised procedure applicants in November 2023. This is currently voluntary, and an alternative eSubmission format can be used until 1 May 2026.

Five of the fifteen nations – Ghana, Nigeria, Cote d’Ivoire, Benin and Cabo Verde – will also begin a pilot phase for national procedures from 30 June 2024.

Initially, ECOWAS is implementing the ICH eCTD v3.2.2 but have stated their intention to migrate to eCTD v4.0 in future implementation plans.

The use of eCTD by all fifteen member countries is expected to facilitate easy submissions, reduce the cost of both submission and assessment, improve collaboration and information exchange among regulators, shorten registration life cycles, and ultimately improve access to critical and essential medicines in the region.

More information on the ECOWAS eCTD implementation project can be found on the ECOWAS eCTD site.

DanielSmith

Daniel Smith, Sr. RIM Consultant

I’m based in the UK, so I monitor the evolving regulatory framework at the MHRA very closely. As of 1 Jan 2024, the International Recognition Procedure (IRP) will replace the European Commission Decision Reliance Procedure (ECDRP). The Mutual Recognition / Decentralised Reliance Procedure (MRDCRP) will also be incorporated under the umbrella of IRP.

The IRP will be open to applicants that have already received an authorisation for the same product from one of MHRA’s seven specified Reference Regulators (RRs), who include the EMA and US FDA. It will allow the MHRA to take into account the expertise and decision-making of trusted regulatory partners for the benefit of UK patients.

The IRP can be used for initial MAA submissions. There are two recognition timetables, 60 days or 110 days, during which the MHRA say they will “conduct a targeted assessment of IRP applications but retain the authority to reject applications if the evidence provided is considered insufficiently robust”. IRP can also be used for post-authorisation procedures including line extensions, variations, and renewals.

Full guidance concerning the new procedure type is available on the gov.uk portal. We also wrote a summary when the guidance was released, which you can read about here.

DarrenOakes

Darren Oakes, Sr. RIM Consultant

I’ve been closely monitoring developments in IDMP, and I’m very interested to see how this continues to evolve in 2024. The EMA and FDA have both hosted recent events on the topic of IDMP implementation – the EMA Product Lifecycle Management (PLM) Value Stream Deep-Dive Webinar, which included content on the Product Management Service (PMS), and the FDA hosted Toward Global IDMP Implementation: A Focus on Global Use Cases.

Both of these events showed that regulatory agencies are continuing to focus on IDMP and its implementation – although we may be some way off FHIR messages, we are certainly seeing regulatory agencies embrace the core concepts of IDMP.

LaelMcMune

Lael McCune, RIM Publishing Consultant

I am looking forward to seeing agencies continue to work towards transparency and global harmonization.

Health Canada will be releasing version 5.2 of their validation rules for eCTD. Master files have been added to multiple xml checks. More information about this guidance, which will be effective April 2024, can be found on Health Canada’s site.

The FDA released a list of proposed legislation for 2024. Topics include change in agent regulatory oversight responsibility for certain products, requiring full disclosures for drugs to promote generic competition, and enhancing FDAs authority to better protect infants and young children. A complete list of proposed legislation can be found in the FDA’s Summary of Legislative Proposals download.

Finally, the EMA will be enhancing their regulatory process with eCTD EU Module 1 Specification V3.1, Validation Criteria V7.1, and updates to accepted file formats. The guidance is open for comment until January 12, 2024. More information can be found on the eSubmission site.


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