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EMA survey on Pharma companies preparedness for BREXIT & revised guidance concerning the ATMPs

EMA survey on Pharma companies preparedness for BREXIT & revised guidance concerning the ATMPs

EMA Faces BREXIT Challenges

With the EMA changing locations from the UK to the Netherlands, many questions have been raised concerning pharmaceutical companies preparing for BREXIT.

The EMA conducted a survey on companies and their preparedness for BREXIT to ensure medicine remain on the EU market. The survey’s purpose is to select the companies who need support concerning medicine supplies in order to protect human and animal health. Additionally, it was conducted to help the EMA and European Commission plan resources in the areas where these submissions will be processed. The survey will also help the EMA prepare for the move.

Results show that there is a greater amount of centrally authorised products (CAPs) for human use than CAPs with UK-based marketing authorisation holders. This is also true for veterinary medicines with over 215 centrally authorised products for veterinary use and 22 CAPs with UKbased marketing authorisations holders. To see the rest of the findings click here  (, 2018).

In January, 2018 the EMA updated its procedural advice on the evaluation of Advanced Therapy Medicinal Products (ATMPs). The EMA is working to improve and facilitate development and patient access to these innovative medicines at a cheaper cost. The update of the guidance strengthens collaboration between EMA’s scientific committees and addresses specific needs of ATMP developers in the evaluation procedure. A presentation of the process provides an overview of the points raised regarding the Procedural Advice on the Evaluation of ATMPs and what is new in the updated version.

To conclude, the revised guidelines are a step forward in the support of the ATMP developers. It ensures safety and encourages ATMPs to plan timely interactions with EMA and ensure an efficient development process.