EMA, FDA in Bilateral Talks on Inspections, Data Integrity

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-14-2015 10:30


Senior leaders from the US Food and Drug Administration (FDA), the European Commission,and the European Medicines Agency (EMA) reviewed their ongoing cooperative activities and discussed strategic priorities for the next two years at their regular bilateral meeting held on June 19, 2015, at FDA headquarters in Silver Spring, Maryland. The European Commission, EMA and FDA organize in-person bilateral meetings routinely to monitor progress and ensure that their collaboration delivers on agreed strategic priorities that promote the safety, efficacy and quality of medicines. The most recent bilateral talks included discussions on inspections and data integrity.

Over the past years, the EMA and the FDA have increased their level of collaboration and sharing of information. According to the EMA, there are now daily interactions, most of them structured around scientific and regulatory working groups or “clusters." The focus of the cluster reviews during the recent bilateral meeting was pharmacovigilance, biosimilars, pediatrics, and veterinary medicines.

Looking ahead, the EMA, European Commission, and the FDA decided to establish a new cluster on patient engagement to share experience and best practices regarding the involvement of patients in the development, evaluation, and post-authorization activities related to medicines. Participants also agreed that communication on the ongoing successful cooperation should be enhanced and that efforts to support communication activities and align core messages should be strengthened. They also agreed to further strengthen their collaboration in inspections and data integrity, safety monitoring of medicines, biosimilars, aediatric medicines, rare diseases, timely access to new medicines, and veterinary medicines as a means to help European Union (EU) regulators and the FDA increase efficiency on a global level and avoid duplication. The planned focus for each area is outlined below.

Patient engagement: The EMA and the FDA aim to expand patient input during the regulatory process, for example to better understand how medicines and the availability of treatments affect patients and how patients approach quality, safety, and efficacy of medicines.

Safety of medicines: The long-term collaboration between the EMA and the FDA in pharmacovigilance has facilitated the exchange of critical information and the coordination of communication to patients and healthcare professionals in the EU and the US. The participants agreed to further strengthen collaboration in the International Pharmacovigilance cluster with a more strategic focus on, among others, the assessment of everyday use of medicines.

Biosimilars: Activities in this cluster will continue to support the global development of biosimilars. The agencies are interested in aligning their scientific approaches to biosimilars to avoid regulatory divergence that may delay patients’ access to medicines.

Pediatric medicines: Because the development of pediatric medicines is largely driven by legislation in the EU and the US, the EMA and the FDA said that they will continue to align their scientific approaches including through “common commentaries” and development plans that help to achieve a rational approach to the conduct of the necessary clinical trials. A workshop to share EU and US experience under their respective regulatory frameworks may be organized in 2016 to further support these efforts, resources permitting.

Rare diseases: Collaboration in the area of rare diseases is of growing importance. Medicines developers can already use a common template to request orphan designation of their medicine in the EU and the US. Building on this approach and the Pediatric Cluster’s work on rare diseases, the EMA and the FDA will establish a joint working group, the Team of International Global Rare Disease Experts (TIGRE), to better support the development of safe and effective medicines for children who suffer from rare diseases.

Timely access to new medicines: By sharing information to facilitate joint approaches, e.g., in scientific advice or the evaluation of medicines, and by building on the best available regulatory practices, the EMA and the FDA aim to minimize divergence and support patients’ early access to new treatments.

Veterinary topics: Recognizing that the One Health concept is a worldwide strategy for expanding interdisciplinary collaboration in all aspects of healthcare for humans, animals and the environment, the FDA and the EMA plan to continue pathways for effective communication and information- sharing activities. Cooperation is particularly strong in the area of novel veterinary therapies, such as stem cells, oncology products, and cytokines. The EMA and the FDA are focusing their efforts to further encourage the development of novel veterinary medicines and to further reduce antibiotic resistance.

Inspections: Progress was also made for the mutual reliance on inspections of drug manufacturing sites. EU regulators and FDA are evaluating how their respective inspectorates, in addition to their regulatory and procedural frameworks to inspect manufacturers of human medicines compare. "This is an essential prerequisite to relying on each other’s inspection findings, avoiding duplication of efforts, and enabling wider inspection coverage," said the EMA in a statement. "Both agencies are working expeditiously towards a plan for a final framework for an agreement and an implementation plan."

Data integrity: Both agencies stressed the importance of data integrity as a cornerstone to establishing and maintaining confidence in test results and agreed to work on communication and training to help increase the awareness of manufacturers.

Source: European Medicines Agency


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