Search Results for ATMP

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Pharma Inspection Co-operation Scheme Criticizes Plan to Lower GMP Requirements for ATMPs By Zachary Brennan - Published 06 March 2017

The regulatory group known as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) said in a letter released this week that it is “unanimously concerned” about the public health and safety impact of a new European Commission guideline that would lower good manufacturing practice (GMP) requirements for advanced therapy medicinal products (ATMPs).

Categories: News, Asia, Canada, Europe, US, EC, FDA, Health Canada, MHRA, TGA, WHO, Crisis management, Government affairs, Manufacturing

Tags: PIC/S, good manufacturing practice for ATMP, European Commission consultation

Advanced Therapy Medicinal Products: An Evolving Regulatory Landscape By Patricia Hurley, PhD, Sarah Jurmeister, PhD, Kathryn Parsley, PhD - Published 28 February 2017

This article was developed from a presentation at RAPS Regulatory Convergence in September 2016 in San Jose, California, US. It was the opening presentation in the "Global Developments in Cell and Gene Therapy" session and covered introductory Advanced Therapy Medicinal Product (ATMP) concepts from definitions to strategic considerations and challenges currently faced by developers in this field.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Human cell and tissue, Regulatory strategy

Tags: Advanced Therapies, ATMP

European Regulatory Roundup: UK Fines Pfizer for 2,600% Price Hike (8 December 2016) By Nick Paul Taylor - Published 08 December 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, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European Regulatory Roundup, Pfizer, ATMP, GMP manufacturing, antimicrobial resistance

European Commission to Overhaul Concept of ‘Similar’ Medicines Within Context of Orphan Legislation By Zachary Brennan - Published 29 July 2016

The European Commission on Friday proposed to review the concept of “similar medicinal products” in the context of its orphan legislation as part of a wider effort to adapt the text to technical progress.

Categories: News, Europe, EC, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Orphan products

Tags: orphan drug legislation, European Commission, gene therapy, ATMP

EMA Reflects on Advanced Therapy Classification By Michael Mezher - Published 08 June 2015

The European Medicines Agency (EMA) has released a new reflection paper discussing how products are classified as advanced therapy medicinal products (ATMPs).

Categories: News, Europe, EMA, Biologics and biotechnology, Human cell and tissue, Regulatory strategy, Submission and registration

Tags: Advanced therapy medicinal products, ATMP, Committee for Advanced Therapies, CAT

EMA Issues New Guideline on Gene Therapy By Michael Mezher - Published 21 May 2015

The European Medicines Agency (EMA) is seeking feedback on a new draft guideline aimed at clarifying the scientific evidence necessary to support the authorization of new gene therapies.

Categories: News, Europe, EMA, ICH, Biologics and biotechnology, Clinical, Human cell and tissue, Preclinical, Quality, Regulatory strategy

Tags: Gene therapy, Advanced therapy medicinal product, ATMP, Glybera

EMA Wants to Clarify Process for Developing Gene- and Cellular-Based Products By Alexander Gaffney, RF News Editor - Published 14 February 2013

Categories: EMA

Tags: CAT, ATMP

EMA Releases Paper on Advanced Therapies to Assist Sponsors By Alexander Gaffney - Published 30 April 2012

Categories: EMA

Tags: Clarification, Voluntary, Submissions, Classification, Advanced Therapy Medicinal Products, ATMP, assistance, Latest News, reflection paper, guidance

Draft Guideline Released on Assessing Risk of Advanced Therapy Medicinal Products in Europe By Alexander Gaffney - Published 24 January 2012

Categories: EMA

Tags: Risk-based Approach, Draft Guideline, Advanced Therapy Medicinal Products, ATMP, Latest News, risk