• EMA Releases New Reflection Paper for Labs Performing Clinical Trial Sample Analysis

    The European Medicines Agency (EMA) announced it has released a new reflection paper to guidance laboratories that evaluate clinical trial samples, which it hopes will establish informal guidelines for laboratories. The paper, Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples , will help sponsors to "develop and maintain quality systems which will comply with relevant European Union Directives, national regulations and...
  • EMA Releases Paper on Advanced Therapies to Assist Sponsors

    The European Medicines Agency (EMA) has released a new reflection paper on the classification of advanced-therapy medical products (ATMPs)-therapies made from genes and cells-which aims to clarify the legal basis for the classification of advanced therapies and provide information to applicants on how to submit applications for approval to EMA. In particular, the paper "provides information on how these medicines are classified as gene therapy, somatic-cell therapy, tiss...
  • Europe: Draft TEP Guidance Issued

    The European Medicines Agency (EMA) has issued a reflection paper intended to provide specific guidance on clinical testing for tissue engineered products (TEP), as well as cells or tissues combined with a medical device and considered a combined Advanced Therapy Medicinal Product (ATMP) and TEPs classified as a Gene Therapy Medicinal Product (GTMP).  A TEP may achieve a total or partial regeneration, repair and/or replacement, and EMA notes that the tissue functi...
  • Europe: EMA Releases New 'Practical Guidance' on Foreign Clinical Trials

    The European Medicines Agency (EMA) yesterday (16 April) published guidance, in the form of a final reflection paper , on ethical and good clinical practice (GCP) aspects of clinical trials conducted outside of the European Union (EU)/European Economic Area (EEA) and submitted in marketing authorization applications to the EU regulatory authorities. The paper, which enters into force on 1 May 2012, is intended to strengthen existing processes to provide assurance to re...
  • EMA Releases Draft Reflection Paper on Tissue Engineered Products

    The European Medicines Agency (EMA) released a draft reflection paper on tissue engineered products (TEPs) and how to best conduct clinical trials to prove their safety and efficacy. TEPs are "innovative and complex medicinal products intended to regenerate, repair or replace human tissue," and EMA notes some clinical studies-particularly those evaluating safe dosing and general safety-may be challenging. EMA's 17 April Draft reflection paper on clinical aspects relate...
  • EMA Issues New Paper on Advancing Ethical Regulatory Framework for Clinical Trials

    The European Medicines Agency (EMA) released a new reflection paper on how to advance the regulatory framework overseeing clinical trials, including how to strengthen clinical trials oversight. EMA's 16 April Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorization applications to the EU Regulatory Authorities seeks to "strengthen existing processes to p...
  • Paper: Regulatory Cost-Benefit Analysis Best Done Out of Spotlight

    • 04 April 2012
    A paper published in the journal Regulation and Governance claims an integral part of the regulatory process is done best when insulated from significant amounts of public scrutiny. The March 2012 peer-reviewed paper, The triumph of regulatory politics: Benefit-cost analysis and political salience , looked at 109 "economically significant" regulations issued by US regulatory agencies between 2000 and 2009. The authors, Stuart Shapiro and John Morrall, hoped "to exami...
  • EMA Adopts Reflection Paper on Evaluating Clinical Trial Samples

    The European Medicines Agency (EMA) adopted a reflection paper that aims to provide quality systems guidance for laboratories in charge of analyzing and evaluating samples generated from clinical trials. Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples , adopted 28 February and released 20 March, intends to provide clinical laboratories "with information that will help them develop and maintain quality systems" that com...
  • EMA Releases Draft Guidance on HIV Prophylaxis

    The European Medicines Agency (EMA) released new reflection paper 15 March on the development of pre-exposure prophylaxis (PrEP) products for Human Immunodeficiency Virus (HIV). The paper, intended for pharmaceutical companies, aims to assist in the development of oral and topical medications to be used as part of an integrated risk-reduction approach. "This reflection paper sets out a consolidated position based on this research, which has culminated in the positive re...
  • EMA Releases Concept Paper on Excipient Labeling

    The European Medicines Agency (EMA) released a concept paper on 8 March about the need to revise current labeling guidelines for medicines containing excipients . Current guidelines contain warnings about the presence of certain excipients, particularly those pursuant to 2001/83/EC Article 54(d) which states that all excipients must be declared if a product is an injectable product or eye preparation. Further, all excipients know to have an action or effect on the body ...