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  • EMA Recommends Vertex's Cystic Fibrosis Drug Kalydeco

    The European Medicines Agency (EMA) has recommended Vertex Pharmaceuticals' cystic fibrosis (CF) drug Kalydeco (ivacaftor), moving the drug one step closer to becoming the drug the first in Europe for the treatment of CF in patients with a specific gene mutation. The drug received the Committee for Medicinal Products for Human Use's (CHMP) recommendation on 25 May after being reviewed under a 150-day accelerated approval program. EMA notes Kalydeco is the eighth pro...
  • EMA Adopts Guidance on Medical Products Containing Genetically Modified Cells

    The European Medicines Agency (EMA) announced 5 May it has adopted a scientific guideline on aspects relating to the development and testing of medicinal products containing genetically modified cells. The scientific guideline addresses the three main areas of drug development: quality considerations within the manufacturing process, non-clinical testing and clinical testing. EMA notes genetically modified cells may either be used as therapies themselves or as part of t...
  • 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 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...
  • UPDATED (2): EMA's Abadie Resigns as Chair of CHMP

    The European Medicines Agency (EMA) announced 4 April that effective immediately, Eric Abadie, chair of the Committee for Medicinal Products for Human Use (CHMP), was resigning from his position. "Executive Director Guido Rasi has accepted his resignation with immediate effect," wrote EMA in a press release. In a statement to Reuters , a spokesman said the move was related to Abadie's position at French regulatory authority Afssaps , where he serves as a scientific ad...
  • EMA Adopts Addendum to CHMP Guideline on PAH Products

    The European Medicines Agency (EMA) adopted on 7 February the Paediatric addendum to the CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension (PAH). The addendum includes guidance on how to develop PAH products for pediatric populations, including points of distinction to be made between idiopathic PAH and associated PAH, ethical issues, considerations for trial selection, feasible trial endpoints, t...
  • EMA Prepares for 'Biggest Change' to Legal Framework Since Founding

    The European Medicines Agency (EMA) announced on 2 February that it "is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change to the legal framework since the establishment of the Agency in 1995." New pharmacovigilance legislation being enacted in July will harmonize adverse drug reaction reporting for all citizens across the EU, according to a statement released by EMA. The legislation also make...
  • EMA Guide on Development of Novel Drug Development Methodologies Released

    The European Medicines Agency (EMA) released a new guidance on 26 January that addresses the development of novel methodologies in drug development, and how EMA develops qualification opinions and advice for scientific methods and protocols. The qualification process is a "new, voluntary scientific pathway leading to either a [Committee for Medicinal Products for Human Use (CHMP)] opinion or a Scientific Advice on innovative methods or drug development tools." The pr...
  • EMA Releases New Guideline on Active Substance Master File Procedure

    The European Medicines Agency released its Guideline on Active Substance Master File (ASMF) Procedure yesterday that aims to improve the ASMF procedure across the European Regulatory Network by having a unique version of an ASMF for one active substance valid for the whole European Union (EU) and European Economic Area (EEA). One assessment report (AR) of an ASMF can be recognized by all Competent Authorities (CAs), thereby improving a product's time to market. The p...
  • EMA Calls for Withdrawal of Marketing Authorizations for Oral Meprobamate-Containing Medicines

    The European Medicines Agency (EMA) today called on EU national regulatory authorities, including France, UK and Italy, to withdraw their respective Marketing Authorizations (MA) for oral meprobamate-containing medications. The medication has been associated with severe side effects including overdose, coma and death. Meprobamate is a prescription sedative medicine used to treat anxiety, alcohol withdrawal, migraine attacks, disgestive disorders, muscle tensions, muscle ...
  • EMA Releases Guideline for Assessing Human Anticancer Products

    The European Medicines Agency released a new guideline today titled, Guideline on the evaluation of anticancer medical products in man . The guideline, adopted by the EMA during the 15 December 2011 meeting of the Committee for Medicinal Products for Human Use (CHMP), aims to provide guidance on the development of medicinal products for use in anti-cancer indications.  More specifically, the guideline provides clarity on: proper dosing of anticancer products...