Search Results for CHMP

Showing 1 – 25  of 41

EMA’s CHMP Adopts Updated Guideline on Manufacture of Finished Dosage Form By Zachary Brennan - Published 14 August 2017

The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) on Monday adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA).

Categories: News, Europe, EC, EMA, Drugs, Manufacturing, Regulatory intelligence

Tags: CHMP, finished dosage form, pharmaceutical manufacturing

EMA Backs Eight New Medicines, Turns Down Drugs From Nektar & Vanda By Michael Mezher - Published 21 July 2017

The European Medicines Agency (EMA) on Friday recommended the approval of eight new medicines after its Committee for Medicinal Products for Human Use (CHMP) met to discuss the drugs earlier this week.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Submission and registration

Tags: CHMP

EMA Recommends New HCV, Cancer and MS Drugs for Approval By Michael Mezher - Published 23 June 2017

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended eight new medicines for approval, including two pan-genotypic hepatitis C (HCV) drugs and a third biosimilar for AbbVie's Humira (adalimumab).

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Submission and registration

Tags: CHMP, Maviret, Vosevi, Imraldi

EMA’s CHMP Recommends Approval for Five New Medicines, Four New Biosimilars By Zachary Brennan - Published 19 May 2017

The European Medicines Agency (EMA) met earlier this week and signed off on five new medicines, including one new advanced therapy, as well as four biosimilars and one generic drug.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Government affairs

Tags: CHMP, Sanofi, Celltrion, XBiotech, Spherox

EMA to Continue to Allow Patient Involvement in CHMP Meetings By Zachary Brennan - Published 08 May 2017

The European Medicines Agency (EMA) said Monday that it will continue to allow patients to offer viewpoints during the assessments of the benefits and risks of medicines before EMA’s Committee for Medicinal Products for Human Use (CHMP).

Categories: News, Europe, EMA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs

Tags: patient perspective, CHMP, benefits and risks of medicines

European Regulatory Roundup: EMA Reviews Drugs Tested at Two Indian Sites (23 December 2016) By Nick Paul Taylor - Published 23 December 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Drugs

Tags: European Regulatory Roundup, CHMP, GCP

European Regulatory Roundup: Report Calls to Minimize Amount of Data Generated by Sponsors (28 November 2016) By Nick Paul Taylor - Published 28 November 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: EU Regulatory Roundup, ENVI, CHMP, MDD

European Regulatory Roundup: Ireland to Offer Regulatory Advice via New Innovation Office (17 November 2016) By Nick Paul Taylor - Published 17 November 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: HPRA, OMCL, drug shortage, CHMP

EMA Recommends Nine Drugs for Approval By Zachary Brennan - Published 11 November 2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it recommended nine medicines for approval at its meeting earlier this week, including four new treatments, three biosimilars and two generics.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Due Diligence, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: EMA CHMP, marketing authorisation in EU, Gilead, Sanofi, Novo Nordisk

EMA’s CHMP Recommends Ban of US CMO’s Medicines By Zachary Brennan - Published 16 September 2016

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Friday recommended that medicines manufactured by Maryland-based contract manufacturing organization (CMO) Pharmaceutics International (Pii) should no longer be available in the EU, except for Ammonaps (sodium phenylbutyrate), which is used to treat a rare disease and is considered critical for public health.

Categories: News, Europe, US, EC, EMA, FDA, MHRA, Crisis management, Drugs, Government affairs, Manufacturing, Quality

Tags: Pharmaceutics International, CHMP, US contract manufacturing of drugs

European Regulatory Roundup: GPs Create Expert Group to Liaise With EMA (5 May 2016) By Nick Paul Taylor - Published 05 May 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Compliance, Drugs

Tags: European Regulatory Roundup, ACS, excipients, CHMP

European Regulatory Roundup: CHMP Adopts Guidance on VTE Treatments (31 March 2016) By Nick Paul Taylor - Published 31 March 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Clinical, Drugs, Due Diligence, Ethics, Manufacturing, Medical Devices

Tags: CHMP, Cardiovascular Working Party, EMA, EDQM, breast cancer

European Regulatory Roundup: Lilly May Move API Production Outside EU Due to REACH Regulations (17 March 2016) By Nick Paul Taylor - Published 17 March 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: EU Regulatory Roundup, Eli Lilly, API manufacturing, REACH, CHMP, DMD

EMA Takes a Firmer Stance on GCP Non-Compliance By Zachary Brennan - Published 01 December 2015

Drug and biotech companies cannot replace pivotal clinical trials that are non-compliant with good clinical practice (GCP) standards during the assessment of marketing authorization applications, according to a new position paper from the European Medicines Agency (EMA).

Categories: News, Asia, Europe, EC, EMA, Biologics and biotechnology, Clinical, Compliance, Crisis management, Drugs, Government affairs, Quality, Regulatory strategy

Tags: good clinical practice, clinical trials, EMA, CHMP, GCP non-compliance

European Regulatory Roundup: MHRA Phasing Out Use of CDs, DVDs in Submissions (30 November 2015) By Nick Paul Taylor - Published 30 November 2015

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Combination products, Drugs, Manufacturing, Research and development, Veterinary products

Tags: MHRA, EMA, Adaptive Pathways, CVMP, CHMP

European Regulatory Roundup: EMA Unveils Antimicrobial Strategy (19 November 2015) By Nick Paul Taylor - Published 19 November 2015

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, MHRA, NICE, Distribution, Drugs, Due Diligence, Ethics, Government affairs, Medical Devices

Tags: EMA, NICE, MHRA, CVMP, CHMP, cholesterol drugs, PCSK9

European Regulatory Roundup: Dutch Regulator Revamps Drug Nomenclature Policy (22 October 2015) By Nick Paul Taylor - Published 22 October 2015

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, ICH, Drugs, Due Diligence, Postmarket surveillance, Quality, Regulatory intelligence, Research and development, Veterinary products

Tags: EMA, MEB, CHMP, veterinary antibiotics, ICH, Pradaxa

European Regulatory Roundup: CHMP Updates Breast Cancer Guidelines (15 October 2015) By Nick Paul Taylor - Published 15 October 2015

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Drugs, Orphan products, Quality, Regulatory intelligence, Regulatory strategy

Tags: EMA, CHMP, quality control, breast cancer, orphan drug, CVMP, PRAC

EMA Issues Guidance on Clarification Meetings By Michael Mezher - Published 10 February 2015

The European Medicines Agency (EMA) is looking to increase transparency between its committees and pharmaceutical companies under a new guideline that went into effect in February 2015.

Categories: News, Europe, EMA, Communication, Drugs, Regulatory strategy, Submission and registration

Tags: List of Questions, List of Outstanding Issues, LoQ, LoOI, CHMP, EMA Product Lead

EU's First Stem Cell Treatment Recommended by EMA By Michael Mezher - Published 07 January 2015

A major milestone in stem cell therapy was reached in December 2014 when a European Medicines Agency (EMA) committee recommended the conditional approval of Holoclar, the first stem-cell product to be recommended for approval in the EU.

Categories: News, Europe, EMA, Biologics and biotechnology, Human cell and tissue, Orphan products, Submission and registration

Tags: Holoclar, Chiesi, Stem Cells, CHMP, CAT, Holostem

EMA Shines a Light into its Black Boxes of Regulatory: Its Review Committee Meetings By Alexander Gaffney, RAC - Published 29 January 2014

Categories: EMA

Tags: CAT, CVMP, Transparency, Latest News, CHMP, committee, review, EU

Following FDA, EMA Launches Review of Emergency Contraceptive Effectiveness By Alexander Gaffney, RAC - Published 24 January 2014

Categories: EMA

Tags: Levonorgestrel, Plan B, CHMP, review, EU

EU Regulators Claim Diabetes Medicines Clear of Safety Fears, but Data Key to Finding By Alexander Gaffney, RF News Editor - Published 26 July 2013

Categories: EMA

Tags: DPP-4, GLP-1, Diabetes, Latest News, CHMP, safety, EU

EMA Recommends Limiting Indication of Cilostazol-Containing Medicines Because of Risks By Alexander Gaffney, RF News Editor - Published 25 March 2013

Categories: EMA

Tags: CHMP, EU

Centralized Procedure to see Simplified Submission Process, Says EMA By Alexander Gaffney, RF News Editor - Published 18 March 2013

Categories: EMA

Tags: PRAC, Centralized Procedure, CAT, Centralised Procedure, application, Latest News, CHMP, submission, EU