In clinical research and drug development, regulatory submissions are critical to bringing these new medicines to market. The marketing authorisation holder (MAH) is a key player in this process.
The marketing authorisation holder is responsible for ensuring a product complies with regulatory requirements throughout its life cycle. If you’re a pharmaceutical or biotech company looking to navigate the complexities of drug development and commercialisation, you must understand the marketing authorisation holder’s responsibilities and requirements, as well as the regulatory landscape.
What are the key requirements for a marketing authorisation holder in the UK/EU?
From securing initial new drug approvals to maintaining compliance, post-market surveillance and engaging with regulatory authorities, a marketing authorisation holder must adhere to strict guidelines to guarantee product safety and efficacy.
1. Regulatory compliance and market authorisation
Marketing authorisation holders must ensure a product complies with all relevant regulations before it’s marketed. This includes submitting the necessary documentation for marketing authorisation to the relevant regulatory body, such as the EMA or MHRA.
The MAH is also responsible for maintaining the authorisation by updating the product information, submitting post-marketing safety data and ensuring continued compliance with good manufacturing practice (GMP) and good clinical practice (GCP).
2. Post-market surveillance
One of the core responsibilities of the marketing authorisation holder is to manage post-market surveillance activities. This involves monitoring the safety and efficacy of the product once it’s on the market, reporting serious adverse events and ensuring risk management strategies are in place. The MAH must comply with pharmacovigilance regulations and provide timely updates to regulatory authorities.
3. Product labelling and information
The marketing authorisation holder is responsible for ensuring all labelling and packaging are compliant with regulatory requirements. This includes making sure product labels, patient leaflets and packaging are accurate, clear and contain all mandatory information, such as dosing instructions, contraindications and potential side effects.
4. Supply chain and quality control
Ensuring the integrity of the supply chain is a crucial part of the marketing authorisation holder’s role. The MAH is responsible for making sure the product is consistently manufactured and distributed in line with regulatory standards. They must also ensure all batches meet the necessary quality standards before being marketed.
5. Engagement with regulatory authorities
The marketing authorisation holder acts as the point of contact between the regulatory authorities and the pharmaceutical company. The MAH must be prepared to handle any requests from authorities, whether they relate to product changes, clinical trial data or safety concerns.
Additionally, in the case of treatments for rare diseases, engaging early and often with regulatory bodies can streamline the approval process and improve the chances of success.
What are the benefits of a designated marketing authorisation holder in the UK/EU?
Regulatory authorities in the UK and EU are increasingly placing a stronger emphasis on adaptive pathways, fast-track approvals and the use of real-world evidence to expedite the availability of treatments for rare diseases. So, there are many advantages to appointing a designated marketing authorisation holder.
1. Enhance regulatory support
With the complex landscape of regulatory requirements in the UK and EU, partnering with an experienced clinical research organisation (CRO) with marketing authorisation holder capabilities ensures you have access to expert guidance on the intricacies of the MAH role. This includes navigating clinical trials and ensuring timely regulatory submissions for market authorisation.
2. Ensure compliance and safety
By having a dedicated marketing authorisation holder, you can reduce the risk of non-compliance with regulatory requirements. This ensures all post-market activities, such as pharmacovigilance and the reporting of serious adverse events, are conducted efficiently, safeguarding patient safety and reducing the risk of product recalls.
3. Optimise market access for therapies for rare diseases
Having a knowledgeable marketing authorisation holder can significantly expedite market access in the UK and EU — particularly if you’re developing therapies for rare diseases. By ensuring timely and accurate submissions, your product can reach the market faster, improving patient access to life-saving treatments.
4. Streamline your global regulatory strategy
A global CRO with marketing authorisation holder capabilities can assist you in navigating not only UK and EU regulations but also those in other major markets, ensuring a streamlined global regulatory strategy. This is critical when you’re involved in drug development for rare diseases, where a unified approach to regulatory affairs can enhance the likelihood of success across multiple regions.
How can you simplify your marketing authorisation application?
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 your drug remains safe, effective and compliant throughout its life cycle.
The marketing authorisation holder’s 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 support for regulatory submissions. These services 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.