EMA
IVDR
July 7, 2022
Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics
This guidance document aims to provide interested parties with appropriate guidance on procedural aspects to facilitate the consultation procedure to the European Medicines Agency (EMA) by notified...
FDA
EMA
July 5, 2022
Global regulators agree on key principles on adapting vaccines to tackle virus variants
News 01/07/2022 On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop...
EMA
Europe
June 24, 2022
EMA Procedural guidance for variant strain(s) update to vaccines intended for protection against Human coronavirus
8 June 2022 EMA/175959/2021 Rev.2 Human Medicines Division Regulatory and procedural requirements Introduction In order to ensure the continued effectiveness of authorised COVID-19 vaccines, it may...
EMA
Europe
June 23, 2022
EMA Checklist for annual updates for parallel distribution - Draft Guidance
22/06/2022 EMA/405782/2020 Rev. 3 Human Medicines Division The European Medicines Agency (hereinafter 'the Agency') asks its applicants to use this checklist in advance of submission of an annual...
FDA
EMA
June 22, 2022
Maximising on Scientific Advice Procedures in Europe
A unique opportunity to interact with medicine regulators in Europe Are you considering requesting scientific advice in Europe? We can help you navigate the various procedures within the European...
EMA
Europe
June 21, 2022
Advice on the designation of antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans - in relation to implementing measures under Article 37(5) of Regulation
Regulatory and Procedural Guideline May 2022 EMA/CVMP/678496/2021-rev Introduction “According to Article 37(5) of Regulation (EU) 2019/6 (‘the Regulation’), the European Commission shall adopt...
EMA
Europe
June 20, 2022
Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)
JUNE 2022 EMA/278419/2022-Rev.1 This validation checklist is used by the Agency to validate initial marketing authorization applications for pharmaceuticals and applicants should use it as a means to...
EMA
MAH
June 15, 2022
EMA adopts first list of critical medicines for COVID-19
News On 7 June 2022, EMA's Medicines Shortages Steering Group (MSSG) adopted the list of critical medicines for the COVID-19 public health emergency. The medicines included in the list are authorised...
EMA
Europe
June 2, 2022
EMA appoints Chief Medical Officer
June 1, 2022 Steffen Thirstrup has been appointed as Chief Medical Officer of EMA. In this role, he will provide scientific leadership across EMA and its scientific committees to reinforce the...