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Tag Archives: guideline

Scientific progress enables EMA to improve guidance on medicinal products containing genetically modified cells

The European Medicines Agency (EMA) has released a concept paper concerning a proposed revision of the current guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells. The proposed revision will update the previous Guideline of 2012. EMA’s concept paper is intended to address the issue that the current guideline does

European Medicines Agency Fine-Tunes Guideline on Fixed Combination Medicinal Products

On 13 May 2015, the European Medicines Agency released for consultation the draft Guideline on the clinical development of fixed combination medicinal products. The draft Guideline is intended to replace the 2009 Guideline on clinical development of fixed combination medicinal products. It is recalled that a fixed combination medicinal product contains two or more active

EMA publishes a draft Q&A document for consultation on the environmental risk assessment guidelines

On 26 March 2015, the European Medicines Agency (“EMA”) published a draft Questions and Answers Document (“Q&A Document“) for consultation concerning the EMA’s Guideline on the environmental risk assessment of medicinal products for human use (“EMA Guideline“). The purpose of the Q&A Document is to clarify and harmonise the use of the EMA Guideline. The

EMA permits the use of a comparator product authorised outside the EEA in clinical studies for biosimilars

The European Medicines Agency’s (“EMA”) revised overarching guideline on biosimilars (“Guideline”), which was published on 23 October 2014, will come into force on 30 April 2015. The purpose of this Guideline is to describe the concept of biosimilars and to outline the general principles to be applied when generating evidence substantiating the similar nature, in

EMA ADOPTS NEW GUIDELINE ON MODIFIED RELEASE DOSAGE FORMS

On 27 November 2014, the European Medicines Agency (“EMA”) published its new guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (the “Guidelines“). Modified release dosage forms are formulations where the rate and/or site of release of the active ingredients are different from that of the immediate release dosage form administered by