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EMA – Committee agendas & minutes (CHMP/PRAC/CAT/…) COMMITTEE
Minutes of the COMP meeting 8-10 September 2026
Minutes of the COMP meeting 8-10 September 2026
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EMA – Committee agendas & minutes (CHMP/PRAC/CAT/…) COMMITTEE
Agenda - Sixth Veterinary Data Stakeholder Forum
Agenda - Sixth Veterinary Data Stakeholder Forum
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EMA – Committee agendas & minutes (CHMP/PRAC/CAT/…) COMMITTEE
Highlights - First European Medicines Agency (EMA) - International Society for Cell and Gene Therapy (ISCT) bilateral meeting
Highlights - First European Medicines Agency (EMA) - International Society for Cell and Gene Therapy (ISCT) bilateral meeting
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EMA – Committee agendas & minutes (CHMP/PRAC/CAT/…) COMMITTEE
Minutes of PRAC meeting on 31 August - 3 September 2026
Minutes of PRAC meeting on 31 August - 3 September 2026
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MHRA (gov.uk) NEWS
MHRA approves new oral treatment for moderate to severe plaque psoriasis
MHRA approves new oral treatment for moderate to severe plaque psoriasis
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for FDA Regulated Products
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal…
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal…
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act…
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Determination of Regulatory Review Period for Purposes of Patent Extension; Correction of Notices-ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; DAYVIGO
The Food and Drug Administration (FDA) is announcing corrections to the notices of Determination of Regulatory Review Period for Purposes of Patent Extension for ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; and…
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US Federal Register – FDA (Rules/Notices/Guidance) NEWS
Questions and Answers Regarding Mandatory Cosmetics Recalls; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry." The guidance document…
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EMA – EPAR documents (JSON) ASSESSMENT
Leqvio-PAM-0000273076 : EPAR - Assessment report
16 October 2025 EMADOC-1700519818-3523548 Human Medicines Division
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EMA – EPAR documents (JSON) ASSESSMENT
Leqvio-PAM-0000273064 : EPAR - Assessment report
16 October 2025 EMADOC-1700519818-3523741 Human Medicines Division
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EMA – EPAR documents (JSON) ASSESSMENT
Trixeo Aerosphere-X-0000287664 : EPAR - Assessment report - Variation
Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone…
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EMA – Committee agendas & minutes (JSON) COMMITTEE
Agenda - Media seminar on vaccines
15 October 2026 28 October 2026; room 1C Chair: Susan Carroll | Item | Preliminary draft agenda | Initials | Mins |…
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EMA – News & press releases (JSON) NEWS
AMA and EMA issue joint guidance on Ebola vaccine development
AMA and EMA issue joint guidance on Ebola vaccine development Press release: No Categories: Human Topics: Clinical trials;Research and development;Vaccines News summary: Clinical trial requirements defined for rapid…
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EMA – Committee agendas & minutes (CHMP/PRAC/CAT/…) COMMITTEE
CHMP PROM minutes for the meeting on 13 April 2026
CHMP PROM minutes for the meeting on 13 April 2026
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EMA – EPAR documents (JSON) REFERENCE
Filgrastim Hexal : EPAR - Procedural steps taken and scientific information after authorisation
Procedural steps taken and scientific information after the authorisation* *Due to the Agency`s update of its procedure management systems, an additional document, reflecting the historical lifecycle may be available in…
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EMA – EPAR documents (JSON) REFERENCE
Kygevvi : EPAR - Procedural steps taken and scientific information after authorisation
Procedural steps taken and scientific information after the authorisation* *Due to the Agency`s update of its procedure management systems, an additional document, reflecting the historical lifecycle may be available in…
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EMA – EPAR documents (JSON) ASSESSMENT
Byfavo-H-C-PAM-0000356205 : EPAR - Assessment report
17 September 2026 EMADOC-1700519818-3341764 Human Medicines Division
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EMA – EPAR documents (JSON) REFERENCE
Taxotere : EPAR - Product information - tracked changes
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS TAXOTERE 20 mg/0.5 mL concentrate and solvent for solution for infusion
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EMA – Committee agendas & minutes (JSON) COMMITTEE
Agenda - Immunogenicity and efficacy of pneumococcal vaccines
22 October 2026 EMA/236032/2026 Public Health Threats knowledge building from the past and future regulatory directions 16-17 November 2026, EMA, Amsterdam Hybrid workshop - WebEx & Room 1D EMA Building
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EMA – Committee agendas & minutes (CHMP/PRAC/CAT/…) COMMITTEE
Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 23 September 2026
Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 23 September 2026
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EMA – Committee agendas & minutes (CHMP/PRAC/CAT/…) COMMITTEE
CHMP PROM minutes for the meeting on 19 January 2026
CHMP PROM minutes for the meeting on 19 January 2026
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EMA – Committee agendas & minutes (CHMP/PRAC/CAT/…) COMMITTEE
Minutes - HMA-EMA joint Network Data Steering Group meeting - 10 September 2026
Minutes - HMA-EMA joint Network Data Steering Group meeting - 10 September 2026
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EMA – Committee agendas & minutes (CHMP/PRAC/CAT/…) COMMITTEE
Minutes - HMA-EMA joint Network Data Steering Group meeting - 17 July 2026
Minutes - HMA-EMA joint Network Data Steering Group meeting - 17 July 2026
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BfArM – Pressemitteilungen NEWS
BfArM startet neues Antragsportal zum Herstellerabschlag für Arzneimittel
Pressemitteilung Nr. 8/26 vom 21.10.2026
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EMA – Committee agendas & minutes (CHMP/PRAC/CAT/…) COMMITTEE
CHMP PROM minutes for the meeting on 16 February 2026
CHMP PROM minutes for the meeting on 16 February 2026
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EUR-Lex – EU-Arzneimittelrecht (Directory 13.30.15) LEGISLATION
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2026 to 31 August 2026 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
| Official Journal | EN C series | | C/2026/5454 | 21.10.2026 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2026 to 31 August 2026 (Published pursuant…
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EUR-Lex – EU-Arzneimittelrecht (Directory 13.30.15) LEGISLATION
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2026 to 30 September 2026 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
| Official Journal | EN C series | | C/2026/5455 | 21.10.2026 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2026 to 30 September 2026 (Published…
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MHRA (gov.uk) NEWS
Government confirms indefinite recognition of CE marked medical devices
Patients across Great Britain will have continued access to medical devices and in vitro diagnostic devices (IVDs) already approved for the EU market.