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European Medicines Agency Updates January – March 2017

European Medicines Agency Updates January – March 2017

Guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied, locally acting in the gastrointestinal tract as addendum to the guideline on the clinical requirements for locally applied, locally acting products containing known constituents – April 04, 2017

This guideline states that, in order to demonstrate therapeutic equivalence, clinical trials are in principle considered necessary, but other models may be used or developed. Depending on the situation, human pharmacodynamic (PD) studies, local availability studies or, where appropriate, even animal or in vitro studies may be considered, provided that the respective methods/models are adequately qualified. Hence therapeutic equivalence of locally applied, locally acting GI products could be demonstrated using alternative models, provided they have been proven to be able to accurately reflect in vivo drug release and availability at the site of action. Read full guideline


Draft guideline on multiplicity issues in clinical trials – March 31, 2017

Multiplicity of inferences is present in virtually all clinical trials. The usual concern with multiplicity is that, if it is not properly handled, unsubstantiated claims for the efficacy of a drug may be made as a consequence of an inflated rate of false positive conclusions. Multiplicity can have a substantial influence on the rate of false positive conclusions which may affect approval and labeling of an investigational drug. A number of methods are available for controlling the rate of false positive conclusions, the method of choice depending on the circumstances. Read Full guideline


Concept paper on revision of the guideline on the pharmaceutical quality of inhalation and nasal products – March 22, 2017

This concerns the guidance document on quality aspects of human medicinal products intended for delivery of drug substance into the lungs or to the nasal mucosa with the purpose of evoking local or systemic effect. For Orally Inhaled Product (OIP) there are two guidelines where quality aspects are covered; “Guideline on Pharmaceutical Quality of Inhalation and Nasal Products” EMEA/CHMP/QWP/49313/2005 Corr and CPMP/EWP/4151/00 Rev. 1, a guideline focusing on the establishment of therapeutic equivalence of two orally inhaled products. Currently the guideline on therapeutic equivalence is under revision and a separate Concept Paper relating to that guideline will be published in parallel. Read Full Guideline


Guideline on the chemistry of active substances – February 13, 2017

This guideline has been prepared in accordance with the structure mainly used for the active substance part in the quality part of the dossier (CTD format). The subheadings have been included for clarity. Several references to ICH guidelines are included in the guideline. While veterinary products are outside the scope of these ICH guidelines there are no corresponding VICH guidelines and the principles outlined in these ICH guidelines may also be relevant to veterinary products. By inclusion of these references it is not the intention to introduce any additional requirements for veterinary medicinal products; on the contrary they are included in order to facilitate flexibility and to allow the applicant the option of using different approaches to product development. Read full guideline


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