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GMP: EMA publishes two advisory Documents addressing a Number of Questions about centralised Admission Procedures

22.09.2011
The EMA has recently published two documents concerning the centralised application procedures for new, generic and hybrid medicinal products. In the Q&A section on its website the European ...

TOPRA: EU Module 1 v1.4.1 Specification

22.09.2011
This document specifies Module 1 of the electronic Common Technical Document (eCTD) for the European Union (“EU”). ...

EMA: Periodic Signal Detection for Centrally Authorised Products Based on Reaction Monitoring Reports

22.09.2011
To describe the process by which identification of new safety signals for Centrally Authorised medicinal Products (CAPs) is conducted periodically in the Pharmacovigilance and Risk Management ...

GMP: Faster Sterility Tests for Biological Products

15.09.2011
The FDA Center for Biologics Evaluation and Research (CBER) in Rockville, MD, published a poster that considers rapid sterility testing and compares different modern methods with compendial methods. ...

EMA: Concept paper on pharmacovigilance implementing measures released for consultation

15.09.2011
The European Commission is seeking views from the public on a concept paper on implementing measures for the performance of activities related to the safety monitoring of medicines. ...

PMR: Non-pharmacy market of OTC products in Poland in 2011-2013

15.09.2011
In 2009 the non-pharmacy market of OTC products (comprising medicines and dietary supplements) rose by around 11% year on year and exceeded PLN 1bn (€231m) for the first time on record. The year ...

EMA: EMA Procedural advice for users of the centralised procedure for generic/hybrid applications

15.09.2011
This document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the ...

EMA: Standard operating procedure for preparation of the public summary of opinion for orphan medicinal product designation.

06.09.2011
This SOP describes the preparation and publication of public summaries of opinion following positive and negative opinions by the Committee for Orphan Medicinal Products on applications for ...

FDA: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring.

06.09.2011
This guidance is intended to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human ...

FDA: Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation.

06.09.2011
This guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met to facilitate the ...