Archive | Source: European Medicines Agency

Press Release: Ten recommendations to unlock the potential of big data for public health in the EU Share

The joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) proposes ten priority actions for the European medicines regulatory network to evolve its approach to data use and evidence generation, in order to make best use of big data to support innovation and public health, in a report published today .

Press Release: PRAC confirms four-week limit for use of high-strength estradiol creams Share

EMA’s safety committee (PRAC) has confirmed its recommendation to limit the use of high-strength creams containing 100 micrograms/gram (0.01%) of estradiol to a single treatment period of up to 4‑weeks. This follows a re-examination of its recommendation of October 2019 which was requested by one of the companies that market high-strength estradiol cream.

UPDATED – Agenda: Pharmacovigilance Risk Assessment Committee (PRAC) (13 – 16 January 2020)

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Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use

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PDCO monthly report of opinions on paediatric investigation plans and other activities (12-15 November 2019)

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UPDATED – Agenda: EMA Committee for Advanced Therapies (CAT) (11 – 13 September 2019)

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Press Release: Mandatory use of international standard for the reporting of side effects to improve safety of medicines

At its December 2019 meeting, EMA’s Management Board agreed to the mandatory use of a consistent international format, the ISO ICSR format, for reporting individual cases of suspected side effects in patients across the world. This follows a recommendation from EMA’s safety committee (PRAC) in October 2019. The use of the new international standard will become mandatory as of 30 June 2022 for all reporting to EudraVigilance, the European database of suspected side effects with medicines authorised in the European Economic Area (EEA).

Agenda: Committee on Herbal Medicinal Products (HMPC) (13 – 15 January 2020)

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Minutes: Heads of Medicines Agencies Meeting (27 – 29 November 2019)

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Decentralised Procedure – Requests to act as RMS

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UPDATED – Agenda: EMA Management Board meeting (18 – 19 December 2019)

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EU PSUR Work Sharing Summary Assessment Report: IASOflu 2.0 GBq/mL, solution for injection (sodium fluoride (18F))

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EU PSUR Work Sharing Summary Assessment Report: IASOcholine 1 GBq/ml, solution for injection (fluorocholine 18F)

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CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines

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Questions and answers on “Information on nitrosamines for marketing authorisation holders”

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UPDATED – Agenda: EMA Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) (9 – 11 December 2019)

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UPDATED – Agenda: Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations (20 November 2019)

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UPDATED – Agenda: Committee for Orphan Medicinal Products (COMP) (16 – 18 July 2019)

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UPDATED – Agenda: Pharmacovigilance Risk Assessment Committee (PRAC) (8 – 11 July 2019)

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EU PSUR Work Sharing Summary Assessment Report: Ciclopirox olamine (all formulations except shampoo)

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