Bringing a new drug to market doesn't end with approval from regulatory authorities. For marketing authorisation holders (MAHs), post-approval regulatory affairs remain a critical phase that requires constant attention to ensure compliance, safety and ongoing efficacy.
In this blog, we'll look at the top five challenges marketing authorisation holders face in post-approval regulatory affairs and how a pharma services company can help you navigate these challenges at every stage of the drug development life cycle.
1. Periodic safety update reports and pharmacovigilance
One of the most significant post-approval regulatory requirements is the submission of periodic safety update reports (PSURs). These reports must be submitted at regular intervals to regulatory authorities, summarising the safety profile of a drug and providing updates on serious adverse events reported globally. As a marketing authorisation holder, you must ensure timely and accurate reporting, which can be complex given the vast amounts of data collected during post-market surveillance.
Partnering with a pharma services company with expertise in drug commercialisation can help you streamline this process. These specialists help MAHs compile the necessary safety data and generate comprehensive PSURs that meet regulatory requirements. By leveraging this expertise, you can stay on top of safety monitoring and the appropriate reporting of serious adverse events to maintain compliance with the regulatory submission process.
2. Compliance with changing regulatory requirements
Staying abreast of global regulatory requirements can be an overwhelming task for marketing authorisation holders. From new drug approval processes to shifting standards for clinical trials, regulatory authorities often implement new rules or amend existing ones, creating an environment of constant adaptation.
As such, MAHs can benefit from the guidance of a pharma services company that remains up to date on the latest regulatory trends and changes. By partnering with a specialist, you gain access to regulatory experts who'll help you navigate evolving requirements, ensuring your regulatory submissions, such as the marketing authorisation application (MAA), are compliant with the latest standards.
3. Serious adverse event reporting and risk management
Managing serious adverse events in the post-marketing phase is another ongoing challenge for marketing authorisation holders. The reporting of serious adverse events is a crucial part of regulatory submissions and must be handled promptly and accurately to prevent patient harm and ensure drug safety. Failure to report adverse reactions can lead to regulatory penalties and damage to your company's reputation.
A strong partnership with a pharma services company can support your risk management strategies and the effective reporting of serious adverse events. These specialists can assist you in monitoring adverse reactions during the post-approval phase, including managing data collection from clinical trials and real-world settings. They also help create risk management plans, including strategies for addressing any safety issues that may arise post-approval.
4. Managing ongoing clinical trials
Even after a drug receives market approval, clinical research doesn't stop. Post-marketing clinical trials, also known as Phase IV trials, play an essential role in gathering more comprehensive data on the long-term effects of a drug, its interactions with other treatments and its real-world efficacy. Ensuring these studies are conducted properly, with the correct regulatory oversight, is a major challenge for marketing authorisation holders.
A pharma services company can help you design and execute post-market clinical trials that comply with regulatory standards. Their expertise ensures your trials are completed on time and data is reported accurately, thereby improving the overall drug development life cycle and supporting your ongoing drug safety monitoring.
5. Handling the regulatory submission process for variations
Once a marketing authorisation application (MAA) is approved, marketing authorisation holders must seek approval for any subsequent variations to the original marketing authorisation, including changes in manufacturing processes, indications or label modifications. These regulatory submissions require careful preparation and coordination, as they need to meet specific regulatory guidelines and be supported by robust clinical data.
Engaging specialist drug commercialisation solutions early ensures you can efficiently manage the regulatory submission process for variations. A pharma services company brings valuable experience in compiling the necessary data, performing regulatory assessments and preparing all required documents. Whether the change is related to clinical trials or new drug approval for additional indications, they can help you navigate these complexities and streamline the regulatory submission process.
TMC can act as your marketing authorisation holder
Post-approval regulatory affairs represent a complex and ongoing challenge for marketing authorisation holders, requiring meticulous attention to detail and compliance with evolving regulatory standards.
By working with a pharma services company like TMC, you can effectively navigate issues such as periodic safety update reports, serious adverse event reporting and regulatory submission processes. With this expert support, you can ensure the continued market success of your product, maintaining the highest standards of safety and efficacy throughout its life cycle.
TMC Commercial provides a full-service drug commercialisation solution, including regulatory compliance and marketing authorisation application support, medical affairs, pharmacovigilance, reimbursement and pharma pricing strategy, distribution and quality assurance.
If your infrastructure is limited, we have the specialist expertise to act as your marketing authorisation holder (MAH), whether as a temporary bridge or a long-term solution. This means you benefit from our operational capabilities while maintaining the strategic flexibility you need to retain control over your products — without the need to out-license.
Find out more about TMC's drug commercialisation solutions or contact our team today at connect@tmcpharma.com to see how we can help you overcome the challenges marketing authorisation holders often face in post-approval regulatory affairs.