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EMA: Guideline for good clinical practice E6(R2) 4 - Step 2b

13.08.2015
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. ...

EMA: Draft guideline on the processing of renewals in the centralised procedure

13.08.2015
This guideline considers issues associated with the processing of renewals in the centralised procedure, with an aim of giving procedural guidance to marketing authorisation holders (MAHs). It has ...

FDA: Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs

13.08.2015
This guidance is developed to provide manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), and/or abbreviated new drug ...

FDA: Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen

13.08.2015
This guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription also ...

RAPS: EMA Updates Two Pharmacovigilance Guidelines

13.08.2015
Today, the European Medicines Agency (EMA) released two revised guidelines, one final and one draft, to clarify certain aspects of pharmacovigilance in the EU.The two guidelines include a draft ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 4, 2015 concerning stimulating the development of medicines for children

13.08.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 4, 2015 concerning stimulating the development of ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 7, 2015 concerning the publication of updated guidelines on the labeling of packaging of medicinal products registered in

13.08.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 7, 2015 concerning the publication of updated ...

EMA: Draft qualification opinion total kidney volume (TKV) as a prognostic biomarker for use in clinical trials evaluating patients with autosomal dominant polycystic kidney disease (ADPKD)

06.08.2015
The Critical Path Institute’s Polycystic Kidney Disease Outcome Consortium (PKDOC) intends to qualify Total Kidney Volume (TKV) as a prognostic biomarker (i.e. predictive for the outcome with ...

EMA: Concept paper on the need for a single note for guidance on the chemistry of active substances

06.08.2015
This concept paper addresses the need to update and revise the guidance available on the chemistry of the active substance (new and existing active substances). There are currently two approved ...

EMA: Concept paper on the revision of the guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant granulocyte-colony stimulating factor

06.08.2015
The current guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor (G-CSF) provides recommendations for the non-clinical and clinical development of ...