15357 results
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Plasma Master File (PMF) background documents
Last updated: 31/12/2009Master File (PMF) background documents … Master File (PMF) background documents …
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News: Release of documents on two medicines temporarily halted
Last updated: 14/03/2017Release of documents on two medicines temporarily … of the release of certain documents requested by third parties … to release the requested documents in accordance with the Transparency … -
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News: Consultation on revised policy on access to documents
Last updated: 17/02/2017revised policy on access to documents … application/pdf policy on access to documents . The policy describes the … applies to grant access to the documents that it holds, in accordance … -
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Documents from advisory groups on clinical-trial data
Last updated: 30/04/2013Documents from advisory groups on clinical-trial … This page lists the documents from the advisory groups … Standing Committee of European Doctors (CPME) Dr Susanna Del Signore …
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Press release: European Medicines Agency widens public access to documents
Last updated: 30/11/2010Agency widens public access to documents … Agency widens public access to documents … release new policy on access to documents 7 Westferry Circus … -
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ICH M2 Electronic common technical document (eCTD) - Scientific guideline
Last updated: 24/09/2010Electronic common technical document (eCTD) - Scientific guideline … Electronic common technical document (eCTD) - Scientific guideline … Step 5 e-CTD Specification Document 7 Westferry Circus …
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Non-clinical documentation for mixed marketing authorisation applications - Scientific guideline
Last updated: 13/10/2005Non-clinical documentation for mixed marketing authorisation … Non-clinical documentation for mixed marketing authorisation … Guideline on Non-Clinical Documentation for Mixed Marketing Authorisation …
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Clinical Trials Information System (CTIS) bitesize talk: Document and personal data in CTIS - February 2023 (updated)
Online, 14:30 - 16:00 Amsterdam time (CET), 23/02/2023, Last updated: 22/03/2023System (CTIS) bitesize talk: Document and personal data in CTIS … remove personal data from Document properties. Sponsors will … System (CTIS) Bitesize talk Document and Personal Data in CTIS Presented … -
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Requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Scientific guideline
Last updated: 28/01/2022Requirements for quality documentation concerning biological investigational … guidance addresses the specific documentation requirements on the biological … requirements for quality documentation concerning biological investigational …
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Quality documentation for medicinal products when used with a medical device - Scientific guideline
Last updated: 08/12/2021Quality documentation for medicinal products when … Quality documentation for medicinal products when … Guideline on quality documentation for medicinal products when …
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Press release: PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel
PRAC, Last updated: 09/06/2017neutropenic enterocolitis with docetaxel … Doctors advised to follow recommendations … neutropenic enterocolitis with docetaxel 30 Churchill Place … -
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Press release: New judicial decisions at odds with EMA's efforts to allow access to documents on medicines
Last updated: 29/09/2016efforts to allow access to documents on medicines … to suspend the release of documents requested by third parties … response to an access to documents request, with appropriate … -
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ICH: M 4 S: Common technical document for the registration of pharmaceuticals for human use - Safety - Scientific guideline
Last updated: 22/07/2016ICH: M 4 S: Common technical document for the registration of pharmaceuticals … ICH: M 4 S: Common technical document for the registration of pharmaceuticals … M 4 S Common Technical Document for the Registration of Pharmaceuticals …
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ICH: M 4 E: Common technical document for the registration of pharmaceuticals for human use - Efficacy - Scientific guideline
Last updated: 22/07/2016ICH: M 4 E: Common technical document for the registration of pharmaceuticals … ICH: M 4 E: Common technical document for the registration of pharmaceuticals … M 4 E Common Technical Document for the Registration of Pharmaceuticals …
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ICH: M 4 Q: Common technical document for the registration of pharmaceuticals for human use - Quality - Scientific guideline
Last updated: 22/07/2016ICH: M 4 Q: Common technical document for the registration of pharmaceuticals … ICH: M 4 Q: Common technical document for the registration of pharmaceuticals … M 4 QCommon Technical Document for the Registration of Pharmaceuticals …
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News: Regulatory information - Committee chairs' handwritten signatures no longer included in opinion documents from March 2015
Last updated: 20/02/2015longer included in opinion documents from March 2015 … have to sign the opinion documents. These signatures are not … the processing of opinions documents and will come into effect … -
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ICH M2 Electronic common technical document (eCTD) - file format criteria - Scientific guideline
Last updated: 12/01/2015Electronic common technical document (eCTD) - file format criteria … Electronic common technical document (eCTD) - file format criteria … developed a file format criteria document which describes required …
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News: Regulatory information - EMA releases practical guidance on access-to-documents requests
Last updated: 24/11/2014practical guidance on access-to-documents requests … on access to unpublished documents Documents Access and Publication (DAP … only to process access to documents requests submitted by citizens … -
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News: European Medicines Agency revises three guidance documents to include orphan-related information
Last updated: 26/02/2013Agency revises three guidance documents to include orphan-related … Agency revises three guidance documents to include orphan-related … acknowledged. 11 January 2021 Doc. Ref. EMEA/CHMP/225411/2006 … -
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Press release: European Medicines Agency advises doctors treating patients with nosocomial pneumonia with Doribax
CHMP, Last updated: 22/06/2012Medicines Agency advises doctors treating patients with nosocomial … CHMP) is recommending that doctors double the dose to 1g every … The Committee also advises doctors that a longer treatment period … -
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News: European Medicines Agency publishes new document on regulatory procedural advice on similar biological medicines
Last updated: 11/04/2012Medicines Agency publishes new document on regulatory procedural … website in existing regulatory documents. It complements existing guidance … complements existing guidance documents on innovative products and … -
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Press release: European Medicines Agency concludes new advice to doctors and patients for Tysabri (natalizumab) needed
CHMP, Last updated: 20/03/2008Agency concludes new advice to doctors and patients for Tysabri … that liver injury may occur. Doctors should monitor the liver … the urine should see their doctor. The CHMP has requested that … -
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Press release: European Medicines Agency concludes new advice to doctors and patients for Champix needed
Last updated: 14/12/2007Agency concludes new advice to doctors and patients for Champix … that updated warnings to doctors and patients are needed to … information for Champix to warn doctors and patients that depression … -
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ICH M4E Common technical document for the registration of pharmaceuticals for human use - efficacy - Scientific guideline
Last updated: 01/07/2003ICH M4E Common technical document for the registration of pharmaceuticals … ICH M4E Common technical document for the registration of pharmaceuticals … M4E(R2) - Common technical document for the registration of pharmaceuticals …
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ICH M4Q Common technical document for the registration of pharmaceuticals for human use - quality - Scientific guideline
Last updated: 01/07/2003ICH M4Q Common technical document for the registration of pharmaceuticals … ICH M4Q Common technical document for the registration of pharmaceuticals … M 4 QCommon Technical Document for the Registration of Pharmaceuticals …