In clinical research and drug development, regulatory submissions are a critical aspect of bringing new medicines to market. One key player in this process is the marketing authorisation holder (MAH).
The role of the MAH is vital and multifaceted, ensuring the entire regulatory submission process is seamless, compliant and, ultimately, successful. In this blog, we’ll take a closer look at the responsibilities of the marketing authorisation holder and the significance of their involvement in regulatory submissions and new drug approvals.
What is a marketing authorisation holder?
A marketing authorisation holder is an entity (often a clinical research organisation or pharmaceutical company) that’s granted the legal right to market a drug or medical product within a specific region or jurisdiction. The MAH holds the responsibility for maintaining product compliance throughout its life cycle — from initial submission to post-market surveillance.
In the context of regulatory submissions, the MAH submits the necessary documentation to regulatory authorities, such as the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA), to secure approval for marketing a new drug. Once the new drug approval is granted, the MAH is responsible for the ongoing compliance of the product.
So, why is the role of the marketing authorisation holder so important? The role of the MAH is crucial for several reasons:
- Ensuring patient safety. The MAH’s ongoing responsibility for post-market surveillance and risk management ensures patients using the drug remain safe, even after it’s approved.
- Maintaining product integrity. The MAH is responsible for ensuring the product remains in compliance with the regulations, even after it has been brought to market. This ensures the drug continues to meet the necessary standards of safety, quality and efficacy.
- Regulatory liaison. The MAH serves as the primary point of contact between the pharmaceutical company and regulatory authorities. They must navigate complex regulatory requirements and facilitate communication between the two parties to expedite the new drug approval process.
- Product life cycle management. The MAH’s involvement extends beyond the regulatory submission process. They play an integral role throughout the entire product life cycle, ensuring all necessary regulatory submissions, variations and renewals are completed on time.
Key responsibilities of the marketing authorisation holder
The marketing authorisation holder plays a vital role in ensuring a drug’s regulatory approval, compliance and ongoing safety. From initial submission to post-market surveillance, the MAH is responsible for maintaining regulatory standards and safeguarding patients.
1. Regulatory submission
The MAH is at the heart of the regulatory submission process. They’re responsible for compiling and submitting the new drug application (NDA) or marketing authorisation application (MAA) to regulatory authorities. This application includes critical data from pre-clinical and clinical trials, including safety and efficacy results, manufacturing processes, labelling and any other relevant information.
A successful regulatory submission involves thorough documentation and accurate reporting to ensure the submission meets the regulatory requirements of the respective authority. The MAH must also be ready to respond to queries or requests for additional information from the regulatory body.
2. Ensuring compliance with regulatory guidelines
Compliance is a core duty of the marketing authorisation holder. The MAH must ensure the drug complies with all regulatory requirements throughout its life cycle. This includes compliance with good manufacturing practices (GMP), good clinical practices (GCP) and good pharmacovigilance practices (GVP). The MAH is also responsible for ensuring the product continues to meet quality standards, even after approval is granted.
By staying updated on regulatory changes and proactively implementing any necessary adjustments, the MAH ensures the ongoing safety and efficacy of the product.
3. Post-market surveillance
The MAH’s responsibilities don’t end once the product is approved. They play a crucial role in post-market surveillance, monitoring the product’s performance in the real world. This includes tracking adverse events, ensuring ongoing patient safety and reporting any safety concerns to regulatory authorities.
Post-market surveillance is essential in identifying long-term effects, ensuring the drug remains safe and effective for the target population. The MAH must also be prepared to update the labelling, provide periodic safety update reports (PSUR) and implement corrective actions when necessary.
4. Managing drug safety and risk
A key responsibility of the marketing authorisation holder is drug safety, which involves conducting risk assessments and implementing risk management plans. These plans are designed to minimise the likelihood of adverse reactions and ensure patients aren’t exposed to unnecessary risks.
MAHs must maintain close contact with regulatory agencies to communicate any changes in the safety profile of the drug and implement strategies to mitigate potential risks.
5. Labelling and packaging compliance
The marketing authorisation holder is responsible for ensuring the drug’s labelling and packaging comply with the regulations set by the governing authorities. This includes ensuring the product’s instructions, usage information, contraindications and warnings are clearly presented and easy to understand. Proper labelling is essential for patient safety and helps healthcare providers make informed decisions about the drug.
6. Handling variations and renewals
After the product is authorised, the MAH is responsible for managing any changes or variations in the product, such as changes to the manufacturing process, indications or labelling. They must submit the necessary documents to regulatory authorities to seek approval for any changes.
The MAH is also responsible for the timely renewal of the product’s marketing authorisation, ensuring the product remains authorised for sale and distribution.
Simplify your marketing authorisation application with TMC
The marketing authorisation holder plays a pivotal role in successful regulatory submissions and ongoing product compliance, making them an indispensable part of the new drug approval process.
From preparing and submitting applications to overseeing post-market surveillance and drug safety, the MAH ensures the drug remains safe, effective and compliant throughout its life cycle.
Their responsibilities directly impact patient safety and product integrity. So, with regulatory landscapes constantly evolving, the MAH must be proactive in keeping up with changes and ensuring continuous compliance.
You can significantly improve your chances of gaining market authorisation approval and secure substantial discounts on EMA fees with TMC’s regulatory submission services, which include acting as your marketing authorisation holder, if you don’t have a presence in Europe, to ensure compliance with all local regulations.
We take on all the legal and regulatory accountability to ensure your product is manufactured, marketed and distributed according to the terms and conditions laid out in the marketing authorisation.
As an established EU/EEA-based marketing authorisation holder with SME status, TMC can be your EU/EEA representative — simplifying new drug approvals and maximising your savings.
Find out more about TMC’s regulatory services or contact our team today at regulatory.services@tmcpharma.com to see how we can support you through the regulatory submission process and help you secure EMA new drug approvals efficiently and cost-effectively.