The new Transparency Regulation came into force in the EU on 27 November 2021. The regulation has significantly increased the burden on companies and impacted the regulatory process. The impact to business includes:
- Companies need to notify EFSA of all studies undertaken to support a new application. The notifications should be made prior to starting the study and the study site is requested to co-notify, confirming that the study is being conducted as described by the applicant. Only companies based in the EU are legally required to respond during the co-notification process and many suppliers of services in other countries will not be familiar with these regulations so you may wish to alert them in advance to expect an email from EFSA. It is also important to remember that if you expand your study plan, you need to notify the additional work. This can easily be forgotten as you finalise a regulatory dossier.
- EFSA is planning to release all non-confidential information relating to an application on Open EFSA after the suitability and completeness check is finished. We have reservations regarding the amount of data to be released, particularly with regards to intellectual property and copyright law. It will be important to ensure that any publications submitted to EFSA for which companies do not own the IPR are not released, particularly since downloaded scientific journal articles are often for individual use only.
- Regulatory submissions are now made via an Electronic Portal hosted by the European Commission. Applicants should not to underestimate the amount of time taken to upload a dossier which is now separated into individual sections, with detailed confidentiality and notification information to be supplied for each document. The time for submission is now greatly increased with the potential for administrative errors.