The SmPC can be viewed as a contract between the marketing authorisation (MA) holder of a medicinal product, who drafts the document, and the regulatory agency, who reviews the document. It contains all the relevant product-specific efficacy and safety information and thus provides the very basis...
Read moreEUDRAC will be exhibiting at the DIA Annual Meeting in San Diego, California, from 23 rd to 27 th of June 2019. We have developed and executed regulatory strategy for numerous clients, operating both in the EU and the US markets. If you are interested in discussing your potential Regulatory Affairs...
Read more10 years ago, the EUDRAC UK team was starting work for its first client. Since then, there has been significant growth in the team, the scope of client projects, the number of disease areas and product types. Here is a top 10 list of the activities we have been involved in during this time: Winner...
Read moreThe 1,500 th study was registered in the EU PAS (Post-Authorisation Studies) Register in April 2019 1 . Following launch of the register in November 2010, it took over 2 years for the first 100 studies to be uploaded 2 , but it is now common for >200 studies to be registered each year 3 . The...
Read moreResults of a previous survey conducted by the EMA showed that 90% of initial MAAs are affected by validation issues. In order to address this, the Agency is now requesting that Applicants include a new validation checklist as part of the MAA dossier. Use of this checklist should help ensure a...
Read moreThe MHRA has recently published a guidance for handling of centrally authorised products (CAPs) with assessment pending on EU exit day. Although the document is concerned with a no-deal scenario, it may also provide an accurate framework in the event of an ordered Brexit, depending on the exact...
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