The European Medicines Agency (EMA) has released a high-level summary of interactions between itself and the pharmaceutical industry. The report covers the 2018-2019 period.
The main focus of industry stakeholder engagement during this period surrounded Brexit preparedness activities. The EMA aimed to maintain high levels of transparency with industry stakeholders to fully prepare for the United Kingdom (UK) leaving the European Union (EU) and becoming a third country. By conducting numerous consultations, with public health in mind, the EMA aimed to allow an undisrupted supply of medicines following the transition period. The report also highlights the importance of support for Small and Medium Enterprises (SMEs) for their crucial role in driving innovation, along with the specific need to support them in Brexit-related activities.
One aspect of the report details discussions surrounding the Regulatory Science to 2025 strategy. Through both public and stakeholder consultation, the strategy has been developed to address gaps between science and healthcare systems. A close collaborative working arrangement with regard to accelerated technological change and innovation in medicine development was also agreed.
A joint task force between the EMA and the Heads of Medicines Agency (HMA) on the availability of human medicines was set up to address the concern of medicine shortages. Working to provide advice and strategic support to meet this objective, the taskforce released a guidance for Marketing Authorisation Holders (MAHs) in the European Economic Area (EEA) on the detection and notification of medicine shortages.
The detection and prevention of nitrosamine impurities in medicinal products is another area requiring a high degree of engagement between industry and the EMA. Following a review of manufacturing by MAHs, a multi-stakeholder meeting was conducted. In response to the lessons learnt from this review, guidance for industry was released and is updated regularly.
Another joint EMA-HMA taskforce covers the challenges of Big Data. Through the work of this partnership, the EU Network Strategy to 2025 will be developed, covering the challenges and use of Big Data. A report covering practical recommendations on changes to “data use and evidence generation in support of innovation and public health” will form a key part of this strategy.
Discussions on the operation of the EU medicines regulatory network covered several topics including EU telematics, the new and enhanced EudraVigilance system, implementation of standards developed by the International Organization for Standardization (ISO) on the identification of medicinal products (IDMP), the development of the Integrated regulatory and scientific Information Management (IRIS) platform and the push towards increased availability of electronic product information (e-PI).
The report additionally covers key issues relating to the implementation of new legislation. The incoming Clinical Trials Regulation and the consequent formation of the Clinical Trials Information System (CTIS) along with the incoming Medical Device and In Vitro Diagnostic Regulations make up the core legislation-based challenges in this period.
To view the full report, click here.