Information for you
On this page, you will find information on the Agency s activities that are most relevant to pharmaceutical industry, including news, and events.
You can contribute to the Agency s work by responding to public consultations.
Survey on applying ‘big data’ in a regulatory setting
The joint Task Force on Big Data of the Heads of Medicines Agencies and EMA has launched a pharmaceutical industry survey on big data to help develop a big data strategy for the European medicines regulatory network. It seeks feedback on current experience, key challenges, applicability and added value of big data in the product lifecycle context. The survey is open until 20 October 2017. The task force will publish a summary report on its outcome. For any queries, please contact [email protected]
Training webinar on preparation of PSURs
EMA is holding a webinar on 22 September 2017 to identify key issues in the preparation of periodic safety assessment reports (PSURs) and share best practices on ways to address them. The webinar will be in the form of a question-and-answer (Q A) session and led by a joint panel of industry and regulators.
Marketing authorisation holders will have access to the new EudraVigilance system as of 22 November 2017. EMA and the European Commission have agreed transitional arrangements to streamline their obligation to continuously monitor Eudravigilance and inform EMA and national competent authorities of validated signals they detect.
EMA has published a report on its stakeholder workshop on the first annivesary of PRIME. The Agency has also published an infographic on the first 12 months of the PRIME scheme, which aims to enhance support for the development of medicines that target an unmet medical need. For more information, see PRIME: priority medicines.
2016 annual report of interactions
EMA has published the 2016 annual report on its interactions with industry stakholders. For more information, see Partners and networks: pharmaceutical industry.
On 31 May 2017, EMA published a Q A providing further detail on location of establishment, following a notice to marketing authorisation holders of centrally authorised medicines to remind them of their legal obligations in preparation for Brexit. For more information, see UK s withdrawal from EU.
Common European Single Submission Portal
EMA and Heads of Medicines Agencies (HMA) have published a statement of intent on replacing electronic application forms (eAFs) for human and veterinary medicines applications by a Common European Single Submission Portal (CESSP). The first version will cover initial marketing authorisation and extension applications, and should be available by Q1 2018. At a later stage CESSP will replace all other eAFs for variation and renewal applications. It will eventually integrate HMA’s Common European Submission Platform (CESP) and EMA s eSubmission Gateway into a single system.
Early development advice services
EMA offers a range of advisory services to companies working in research and development of medicines. EMA has developed a consolidated list of available guidance and opportunities for interaction in the development phase of a human medicinal product. For veterinary medicines, specific early development services include scientific advice, the Innovation Task Force and veterinary pre-submission meetings.
Submission dates (human and veterinary)
See the submission dates and procedural timetables for human medicines, including marketing-authorisation applications, extensions, variations and referrals and the submission dates for veterinary medicines, including maximum residue limits procedures.