Report of second EMA- AESGP annual bilateral meeting 11 January 2017, European Medicines Agency
Objectives of the meeting To provide an annual opportunity for EMA to engage individual industry stakeholder associations in dialogue on key areas of mutual interest, to share information, exchange views and enhance the EMA understanding of the needs and expectations of its stakeholders. Topics addressed at the meeting AESGP Self-Care agenda and priorities •
AESGP Self-Care Agenda 2020 and priorities framework was presented. The focus is on proposals for non-prescription medicines improvements within the existing legislative framework. Establishing evidence-based policies, enhancing cooperation between stakeholders, creating more incentives for innovative self-care, reducing administrative burden, using procedures for market access efficiently and a risk-based implementation of rules are amongst other proposals made by AESGP to achieve its objectives.
Centralised procedure & non-prescription medicines: taking stock of the last 10 years and the way forward •
EMA provided an update on 10 years of “switching” legal status to non-prescription for centralised and nationally authorised medicinal products, acknowledging the limited use of the centralised route over that period i.e. only 7 “switches” applications were submitted centrally. For the vast majority of medicines the change of legal status is done at national level. A brief summary of the incentive of Article 74a of directive 2001//83/EC was also briefly discussed together with future procedural and stakeholder engagement proposals.
•
AESGP highlighted their support for the centralised route as the path to innovation of the self-care sector given a number of centrally authorised medicines could give rise to innovative switches. AESGP also shared their reflections on centralised “non-prescription” medicines challenges, benefits and ideas for changes. Amongst existing challenges, the generation of “OTC experience” without prior approval was highlighted. A staggered approval mechanism and recognition of a new methodological approach to aid the benefit-risk assessment of non-prescription medicines recognising the benefit of access were presented as ideas for changes.
•
EMA presented a proposal for a multi-stakeholder Scientific Advice for OTC switch. Further information will be published shortly.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
Linking SPOR implementation and optimisation of regulatory processes •
EMA gave an overview of SPOR/ISO-IDMP rationale, objectives, benefits development and timelines update – see presentation.
•
The perspective of AESGP on SPOR/ISO-IDMP implementation and potential for regulatory process optimisation to drive quality data generation, regulatory process simplification and global alignment was discussed. The importance of ensuring stakeholder (Regulators (EMA and NCAs) and Industry) awareness, and engagement, through effective and timely communication was highlighted. In particular the need for timely communication of any amendments in project timelines was flagged as a critical point for Industry to mobilise resources and budget within their organisations.
•
AESGP emphasised the importance of EU telematics tools to enable the objective of regulatory process optimisation within EU network and in that respect welcomed the creation of the HMA-EMA Regulatory Optimisation Group to interconnect the many telematics initiatives and multidisciplinary process overview across the network to foster simplification and optimisation in terms of process management and resources.
Framework for interaction with the industry •
AESGP gave positive feedback on their cross Agency-AESGP interactions over the past couple of years and on the role of the industry liaison as facilitator. Suggestions for further optimisation were shared and will continue to be discussed post-meeting.
Report of second EMA- AESGP annual bilateral meeting EMA/52182/2017
Page 2/3
Participants List
EMA
Marie-Helene Pinheiro
Industry Stakeholder Liaison, Corporate Stakeholders (Chair)
(AESGP) annual bilateral meeting - European Medicines Agency
Feb 22, 2017 - route over that period i.e. only 7 âswitchesâ applications were submitted centrally. For the vast majority ... Head of Business Data and Analytics.
Jan 3, 2017 - Linking SPOR implementation and optimisation of regulatory processes. 15:45 â 16:15. 5. Framework for interaction with the industry including ...
Jun 16, 2016 - Send a question via our website www.ema.europa.eu/contact ... Internal awareness raising events for 20th anniversary . ..... Social media.
Sep 16, 2016 - 1. We have a question related to offering a discount if an event is delivered via webinar. Can you please advise if the Agency is planning to ...
Jun 16, 2016 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom ...... and at the meeting with all eligible patient organisations. ...... The PCWP has five topic groups, one of which (social media) is a joint group with ...
Jun 1, 2017 - An agency of the European Union ... clarified that new information was collected which will shortly be taken into account in the 5-year revision.
Sep 26, 2016 - Support for medicines development and market access ... the application process (application form) for direct involvement in EMA activities ...
Apr 28, 2017 - 2. The United Kingdom will then become a 'third country'. 3. Preparing for the withdrawal is therefore not just a matter for EU and national authorities, but also for private parties. In view of the considerable uncertainties, in parti
May 30, 2017 - Pharmaceutical companies are invited to present their pre-clinical data pertaining to ... patients per year, as many questions about the best use of ALK ... of knowledge and evidence to support the planning and regulatory.
Jun 16, 2016 - EMA/140840/2016 .... Annex I. Core business statistics . .... Agency and calls on the Agency to implement in 2016 the remaining actions to address the ..... monitoring conducted in September showed overall positive trends ...
Jun 1, 2016 - Administration and Corporate Management Division ... Accounting Officer's certificate on the annual accounts for the financial ...... In the case of the Agency this comprises computer software licences, consulting and internal ...
Apr 10, 2018 - The annual report is prepared by the EMA's SME Office and provides an overview of SME related activities at ... companies with a valid SME status at year end 2017 (see online SME register). 2006 2007 ... through the SME Office helpdesk
Sep 16, 2016 - case of a previous executive role in a pharmaceutical company or a ..... The implementing rules apply to both staff members and candidates for ...
19/05/2016 - The numbers on page 83 for Austria, Czech Republic and Slovenia were updated. 18/07/2016 - The key on .... As in 2014, we have also seen a trend during 2015 of more ...... well as changes in business process es in relation to ...
Jun 16, 2016 - Agency and calls on the Agency to implement in 2016 the remaining actions to address the comments made ...... industry to reflect the use of social media and other tools in ...... Launch campaign on the 20th anniversary of the.
Sep 26, 2016 - 13 October 2016, 9:00 â 12:00, room 7/B, via teleconference. Health and safety information. In accordance with the Agency's health and safety ...
Jan 16, 2018 - framework of Regulation (EC) No 1049/2001 on access to documents because they are subject to on- going procedures for ... Co-rapp: C. Muñoz. For decision: Need for oral explanation. For adoption: Scientific overview and list of outsta
