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News: Europe to boost international cooperation on generics
Last updated: 19/01/2015international cooperation on generics … international cooperation on generics … EMA/789664/2014 International Generic Drug Regulators Programme … -
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News: Europe to boost cooperation with international partners on generics
Last updated: 07/08/2014international partners on generics … assessment of applications for generic medicines as part of the … part of the International Generic Drug Regulators Pilot (IGDRP … -
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News: Regulatory information – application deadline for participation in information-sharing pilot project for generics extended
Last updated: 21/04/2015information-sharing pilot project for generics extended … information-sharing initiative for generics has been extended to give … part of the International Generic Drug Regulators Pilot (IGDRP … -
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Press release: European Medicines Agency and FDA announce launch of generic medicines application inspections initiative
Last updated: 18/12/2013and FDA announce launch of generic medicines application inspections … and FDA announce launch of generic medicines application inspections … Press release_Joint EMA FDA generic medicines bioequivalence … -
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Press release: European Medicines Agency update on Diane 35 and generics used in the treatment of acne
Last updated: 30/01/2013Agency update on Diane 35 and generics used in the treatment of acne … ethinylestradiol 35 micrograms) and its generics for acne treatment in France … considered that Diane 35 and its generics carry a risk of thromboembolism … -
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First annual bilateral meeting between the European Medicines Agency and the European Generic and Biosimilar Medicines Association
European Medicines Agency, London, UK, 27/01/2016, Last updated: 27/01/2016Medicines Agency and the European Generic and Biosimilar Medicines … Agency (EMA) and the European Generic and Biosimilar Medicines … Medicines Agency and the European Generic and Biosimilar Medicines … -
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European Medicines Agency (EMA)/European Generic medicines Association joint workshop on the impact of the revised EMA guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms
European Medicines Agency, London, UK, 30/04/2015, Last updated: 04/05/2015Medicines Agency (EMA)/European Generic medicines Association joint … Medicines Agency (EMA)/European Generic medicines Association joint … Agency (EMA)/ European Generic medicines Association (EGA … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 November 2015
Last updated: 20/11/2015birch bark extract. Three generic medicines received positive … -
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Leaflets
Last updated: 23/09/2016 -
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Workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies
European Medicines Agency, London, UK, 24/10/2011, Last updated: 15/06/201224/10/2011 EMA/838645/2011 Generic Report - Closed workshop … 15/06/2012 EMA/97951/2012 Generic List of participants: Closed … 15/06/2012 EMA/362428/2012 Generic Presentation - Draft guideline … -
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Tenth industry stakeholder platform on the operation of pharmacovigilance in the European Union
European Medicines Agency, London, UK, 03/02/2017, Last updated: 30/03/201716/05/2017 EMA/80558/20177 Generic Agenda - Tenth industry stakeholder … 02/02/2017 EMA/42931/2016 Generic Presentation - Progress update … WC500224827_en.pdf 30/03/2017 30/03/2017 Generic Presentation - 2017 PRAC … -
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Seventh industry stakeholder platform: operation of European Union pharmacovigilance legislation
European Medicines Agency, London, UK, 04/04/2016, Last updated: 29/04/201623/05/2016 EMA/241387/2016 Generic Agenda - Seventh industry … 01/04/2016 EMA/179833/2016 Generic Presentation - Good pharmacovigilance … WC500205596_en.pdf 29/04/2016 29/04/2016 Generic Presentation - Update on … -
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Workshop on generation and use of Health Based Exposure Limits (HBEL)
European Medicines Agency, London, UK, from 20/06/2017 to 21/06/2017, Last updated: 04/08/201704/08/2017 EMA/410936/2017 Generic Agenda - Workshop on generation … 10/07/2017 EMA/274950/2017 Generic Presentation - Health-based … WC500230954_en.pdf 10/07/2017 10/07/2017 Generic Presentation - Setting health-based … -
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Multistakeholder workshop on EMA’s extended mandate
Online, 01/04/2022, Last updated: 18/11/2022Draft 07/03/2022 05/04/2022 Generic Report - Multistakeholder … multistakeholder_workshop_on_emas_extended_mandate_-_protecting_public_health_in_times_of_crisis_en.pdf 18/11/2022 Generic Presentation - Opening statements … opening_statements_from_stakeholders_-_adrian_van_den_hoven_medicines_for_europe_director_general_en.pdf 05/04/2022 Generic Presentation - Session 1 … -
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Industry stakeholder platform on the operation of the centralised procedure
European Medicines Agency, London, UK, 24/04/2015, Last updated: 29/04/201529/05/2015 EMA/290883/2015 Generic Agenda - Industry stakeholder … 29/04/2015 EMA/207894/2015 Generic Presentation - Status update … WC500186273_en.pdf 29/04/2015 29/04/2015 Generic Presentation - European Medicines … -
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Management Board meeting: 16 March 2017
European Medicines Agency, London, UK, 16/03/2017, Last updated: 03/04/201703/05/2017 EMA/MB/183915/2017 Generic Agenda for the 95th meeting … 17/03/2017 EMA/MB/1181/2017 Generic Decision of the Management … 17/03/2017 EMA/MB/27838/2017 Generic Rules for reimbursement of … -
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Update on the implementation of policy on publication of clinical data (Policy 0070) – Industry associations webinar
European Medicines Agency, London, UK, 29/06/2017, Last updated: 05/07/201705/07/2017 EMA/337506/2017 Generic Presentation – Update on … WC500230630_en.pdf 05/07/2017 05/07/2017 Generic Presentation – Topics raised … WC500230631_en.pdf 05/07/2017 05/07/2017 Generic Multimedia Related content … -
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Management Board meeting: 16-17 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 16/03/2022 to 17/03/2022, Last updated: 07/07/202218/03/2022 EMA/MB/30014/2022 Generic Minutes of the 115th meeting … 16/06/2022 EMA/MB/169135/2022 Generic OPEN Pilot: One-year review … 07/07/2022 EMA/6881/2022 Generic Outcome of written procedures … -
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Network Portfolio
Last updated: 22/11/202208/09/2022 EMA/32271/2022 Generic Agile transformation EMA …
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Policies and procedures
Last updated: 04/01/2022EMEA/MB/355781/2007Rev.1 Generic Policy 4: Health and safety … 06/09/2012 EMA/65832/2011 Generic Policy 9: Appropriate coordination … 31/10/2008 EMEA/124704/2005 Rev. 1 Generic Policy on scientific publication …
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Paediatric Committee (PDCO) (updated)
Last updated: 20/01/202315/10/2021 EMEA/348440/2008 Rev. 3 Generic PDCO work plan 2023 PDF icon … 20/01/2023 EMA/PDCO/867297/2022 Generic PDCO work plan 2022 PDF icon … 21/02/2022 EMA/PDCO/517591/2021 Generic Role and responsibilities …
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Data protection and privacy
Last updated: 04/04/202225/01/2023 EMA/905403/2022 Generic European Medicines Agency’s … 23/01/2023 EMA/932402/2022 Generic European Medicines Agency's … 22/12/2022 EMA/931102/2022 Generic European Medicines Agency’s …
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Open letters
Last updated: 07/12/2021french_translation_-_reply_to_rivasi_pedicini_and_metz_-_meps_2021-11-3_fr.pdf 07/12/2021 Generic Reply to open letter from … 27/05/2021 EMA/292405/2021 Generic Reply to open letter concerning … 26/03/2021 EMA/140520/2021 Generic Letter from the chairs of …
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Management Board meeting: 7 October 2021
European Medicines Agency, Amsterdam, the Netherlands, 07/10/2021, Last updated: 18/01/202207/10/2021 EMA/MB/218267/2021 Generic Minutes of the 113th meeting … 18/01/2022 EMA/MB/571618/2021 Generic Decision of the Management … 11/10/2021 EMA/MB/458302/2021 Generic Summary of transfers of appropriations … -
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Central register of data processing records
Last updated: 25/01/202125/01/2023 EMA/905306/2022 Generic Records of data processing … 24/01/2023 EMA/112992/2022 Generic Records of data processing … 23/01/2023 EMA/945990/2022 Generic Records of data processing …