1. US MONOGRAPH PRODUCT EXPANSION IN THE EU
The Scope – The consumer health division of a blue chip company engaged TRAC on a global expansion project for a US over-the-counter (OTC) Drug Monograph product that had been on the market for several decades. The work centred on creating an EU standard CTD dossier; authoring Module 2 quality overall summary (QOS) and Module 3.
The Challenge – Such a scenario creates unique challenges. Despite these products often being on the market for some time, they generally have very little regulatory documentation associated with them and so EU compliant CTD dossiers often have to be written from complete scratch. In addition, manufacturing sites that are experienced in making monograph products only, do not always have the knowledge or systems/processes in place to adhere to strict EU requirements, particularly around testing of the finished product.
The Project – Following an initial review of the provided site documentation and in order to address issues in the most time efficient manner, Lisa Pascoe, one of TRAC’s Project Managers traveled to the manufacturing site in the US. This gave the opportunity to discuss the product development history with the technical team, search through document archives to assess what could be used to support dossier authoring and offer specialist guidance on the EU compliance requirements of an OTC product outside of the US.
The Outcome – It turned out that there was a lot of more data and valuable documentation in the archives than originally realised, which ultimately saved a lot of time and expense for the manufacturing site. They amended their processes and the client received an EU standard CTD dossier ensuring product expansion plans could become a reality. As TRAC conducted all the authoring within the clients systems, their own regulatory team could continue with future maintenance activities with ease.
2. EU EXPANSION OF MATURE OTC PRODUCTS
The Scope – Following the acquisition of 4 mature analgesic products, that had been licensed in only one EU market previously, a consumer healthcare company sought support from TRAC with regulatory compliance matters that were critical to securing the company’s continued sales growth in the EU.
The Challenge – This scenario presents its own challenges. Even though the product will already have a CTD dossier (or possibly documentation in NTA format), it is likely the documentation is not up to standard to undergo the scrutiny of a new marketing authorisation assessment and support further registrations. Mature dossiers generally contain a lot less information and, although not technically out of compliance, the lack of data would raise significant questions from agencies if presented now. Additionally, although the sites are manufacturing the products in accordance with EU requirements, they often have resource constraints which make it hard for them to support activities that fall outside of routine production, such as dossier overhauls.
The Project – Graham Donaldson, a Project Manager at TRAC, conducted full gap analyses of the existing dossiers and the results were discussed directly with the client’s manufacturing sites so they understood exactly what was required. As time was of the essence, Graham then held regular teleconferences with the sites to ensure that information was being gathered quickly and effectively. Graham introduced the use of document templates with appropriate levels of process, detail and authoring style which meant that the client would not have to invest in excessive and unnecessary dossier updates when applying for post-approval variations, as recommended by the European Medicines Agency (EMA).
The Outcome – The client received EU CMC sections for each product to allow market expansion and which were authored to ensure ease of future life-cycle management. With TRAC taking on all aspects of the project, the clients’ regulatory team was free to focus on servicing their busy, existing product lines.