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.
Learn more about how the pharmaceutical Industry is actively involved in the work of the Agency.
Human medicines highlights for 2016
EMA has released an overview of its key recommendations in 2016 on the authorisation of new medicines. EMA recommended 81 medicines for marketing authorisation. This includes recommendations for 27 new active substances.
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.
Mandatory electronic submissions (human and veterinary medicines)
Electronic application is mandatory for all human and veterinary centralised procedure submissions since 1 July 2015. As of the same date, for the human centralised procedure, the use of the central repository is also mandatory and applications should be submitted to the European Medicines Agency (EMA) only via the eSubmission Gateway / Web Client. Additional applications should not be sent to individual Member States.
Introduction to SPOR data services
EMA organised a webinar on 4 August outlining the substance, product, organisational and referential (SPOR) data services and related impacts. The presentation and video recording of the webinar is available on the event page. EMA is establishing these services for the central management of data to facilitate the implementation of the ISO standards for the identification of medicinal products (IDMP).
Early development advice services (human and veterinary medicines)
EMA offers a range of advisory services to companies working in research and development of medicines, including scientific advice and protocol assistance, the small and medium-sized enterprise office, the Innovation Task Force (ITF) and paediatric early interaction meetings. For veterinary medicines, specific early development services include scientific advice, the ITF 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.
News for industry
Six medicines recommended for approval, including three orphans ... Read more
EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
Medicines where suitable alternative data are available can remain on market ... Read more
EU vaccine composition advice is based on WHO recommendations ... Read more
Task force to establish roadmap and recommendations for use of big data in assessment of medicines ... Read more
EMA to set up technical group in the context of the publication of clinical data ... Read more
- See all News for industry
Events of interest
The Quality Working Party is organising a workshop on the 'Guideline on pharmaceutical development of medicines for paediatric use'. The guideline has been in force as of February 2014 and is intended to provide additional guidance to pharmaceutical developers on quality aspects related to medicinal products for children between birth and 18 years of age. As more experience becomes available, further work is required to complement the guideline with additional recommendations on pharmaceutical development of paediatric medicines. The general scope of this workshop is to share the experience gained so far with the use of the guideline among stakeholders (regulators, healthcare professionals, academia and industry) and identify gaps in current knowledge. This workshop should be considered as a starting point for discussions. ... Read more
The Innovative Medicines Initiative (IMI) WEB-RADR project aims to explore the use of mobile technologies and social media to further improve the collection and analysis of information on the suspected adverse drug reactions. This includes the use of mobile apps to report adverse reactions, the possibility identifying potential safety issues with medicines from user comments (posts) on social media as well as the safety information on medicines. The workshop provided an opportunity to discuss expectations with different stakeholders such as members of the European Medicines Agency (EMA) Healthcare Professionals’ Working Party, the Patients’ and Consumers’ Working Party, the Pharmacovigilance Risk Assessment Committee, representatives of young people from the Paediatric Committee, experts in pharmacovigilance, medical ethics and data protection as well as the IMI WEB-RADR Consortium. The report on the outcome of the workshop hosted by EMA is available on the IMI website. ... Read more
Micro, small and medium-sized-enterprise (SME) workshop: Focus on chemistry, manufacturing and controls (CMC) regulatory compliance for biopharmaceuticals and advanced therapies
This year's micro, small and medium-sized-enterprise (SME) workshop title 'Focus on chemistry, manufacturing and controls (CMC) regulatory compliance for biopharmaceuticals and advanced therapies' aims to provide training on topics such as building quality documentation early during development, manufacturing perspectives, veterinary products, CMC and investigational medicinal product dossiers (IMPDs), and analytical perspectives. Registration by invitation only. Registration open until 20/3/2015. Places limited. ... Read more
Expert meeting on the clinical investigation of medicines for the treatment of paediatric hepatitis C
This is an expert meeting on the clinical investigation of medicines for the treatment of paediatric hepatitis C. The aim of the expert meeting is to take up-to-date scientific developments in understanding and treating hepatitis C into consideration when discussing Paediatric Development Plans and to discuss how the therapeutic needs for paediatric hepatitis C can be better addressed. This will also include discussions on how to facilitate paediatric drug development. ... Read more
The invitation-only conference is organised to celebrate the 20th anniversary of the European Medicines Agency. Looking back at the past two decades, the Agency is proud of its successes, impressive growth and achievements. Yet, in addition to celebrating past successes, the Agency has its eyes firmly set in the challenges of the future. Cognisant of its pivotal role at the crossroads of life science research and development, patient care, public health policy and law, the Agency will use this event to explore with a range of stakeholders how best to deliver its role in the future. ... Read more
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