Marketing authorisation application checklist for Global Regulatory Affairs Directors
Planning and delivering pharmaceutical product approvals across regions globally is not an easy undertaking. Fortunately, at Arex Advisor we are experienced in multiple facets of the process. Below, we have listed some of the key factors to ensure success, and how to steer clear of common pitfalls.
More material related to global MAAs:
Guide to Chemistry Manufacturing Control (CMC) for global MAAs
Labelling considerations for global MAAs
Regionality considerations for global MAAs
Carefully consider how the choice of regions and local markets impact your strategy and planning – across multiple areas:
- Which markets are in scope, which order will the applications be submitted, and which authority approvals are the most pivotal to receive first? How and where is it desirable to group markets applications together, for example in a centralised application approach?
- Throughout the full application planning, understanding the regulatory guidelines and requirements is of high importance. Across some regional requirements there may be common elements, while for other there may be opposing requirements. Mapping out the landscape early enables the identification of both synergies and pitfalls.
- Recognise for which markets local expertise is required, either in the form of a local marketing company or a local market consultant acting on your behalf.
- Where possible, communicate with the key health authorities early. A scientific meeting during the earlier planning phases can enable identification of concerns before it is too late to address them.
- Going hand in hand with the global application plan, the clinical study programme has to be aligned to ensure the clinical data generation for meeting regulatory requirements. Additional clinical trials (e.g. bridging studies) should also be considered depending on regional requirements.
Read our quide to Chemistry Manufacturing Control (CMC) for global MAAs here
Efficient MAA project management and coordination
Ensure close collaboration across departments (e.g. Clinical, CMC, Regulatory Affairs etc.). Each party have separate responsibilities and coordinating their contributions is essential for success.
While it is natural to plan for all known factors, it is also important to acknowledge that unknown factors might come up. Therefore, there should be sufficient room in the timeplan for unexpected regulatory events, e.g. HAQ’s, rejections, manufacturing site issues, shifting requirements, emerging safety or clinical data etc.
Read more about valuable regulatory affairs services for global projects
Documentation and dossier preparation, incl. labelling
There may be regional differences to both the format (e.g. CTD, eCTD, or non-eCTD structures) and the technical requirements for submissions (e.g. different electronic solutions, or physical).
Develop a harmonised labelling strategy, to reflect the company position on product information while also considering common regional requirements.
Read more about labelling considerations for global MAAs here
Risk management and pharmacovigilance planning
Develop a pharmacovigilance strategy, including a global risk management plan, that meets different regional requirements. The plan should also include post-marketing commitments based on local needs.
How Arex supports with pharmacovigilance services for EU compliance.
Timely management of HAQs post-approval commitments and lifecycle management
Proactively anticipate the areas where authorities may ask questions and ensure you have allocated resourcing and staffing for this well in advance. Once a health authority question has been received, the clock starts for providing a response. You should know who to contact for support in all relevant areas. Whether internal experts or external partners, make sure they are identified.
Health authority approvals may come with commitments: In the post-approval lifecycle management, establish a clear strategy for managing changes and regulatory updates – including meeting commitments on time.
In the post-marketing phase and beyond, keeping up with updates in regulations is important to ensure compliance, as these changes may require new regulatory submissions.
Conclusion
In the ever-evolving regulatory landscape, it is wise to build a team of initiated experts to navigate accurately. Knowing who to turn to for advice when the regulatory clock is ticking can make the difference between success and failure.
The Arex Regulatory Affairs team has the skills and experience to complete your team in global MAA projects.
Read more about our services here:
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