EN PL

News

GMP: GDUFA: New Fee Act for the Generic Drugs and APIs Industry adopted by the Congress

26.07.2012
The US Congress passed the so-called \"Generic Drug User Fee Act\" (GDUFA). This act allows the FDA to charge Generic Drug companies who submit a marketing authorisation application for generics ...

EMA: Draft Quality Review of Documents human product information annotated template: revision of the product information

19.07.2012
The purpose of this revision of the Quality Review of Documents human product information is to implement the new provisions from the pharmacovigilance legislation. This consultation aims to ...

EMA: Adopted guideline on setting specifications for related impurities in antibiotics

19.07.2012
This guideline has been developed in order to provide guidance on how specifications for related impurities in antibiotics that are fermentation products or semi-synthetic substances derived from ...

GMP: Revised Guideline on Renewals in the Centralised Procedure Effective

19.07.2012
The document describes a 120-day timetable presenting the respective actions at specific times which the applicant must observe. Moreover, the Guideline provides detailed information on the ...

EMA: Guideline on Active Substance Master File Procedure

19.07.2012
This Guideline is intended to assist Applicants/MA holders in the compilation of the active substance section of their dossiers for a Marketing Authorisation Application (MAA) or a Marketing ...

MHRA: Guidance for notified bodies on the regulation of IVDs for self-testing

12.07.2012
This guidance is intended to support the notified body assessment and although it is not aimed directly at manufacturers of self-tests, notified bodies may wish to share this guidance with ...

EMA: Guideline on the investigation of drug interactions

12.07.2012
The potential for pharmacokinetic interactions between new medicinal products and already marketed drugs should be evaluated. This applies to both effects of the medicinal product on other drugs ...

Polish Ministry of Health: Regulation of Polish Minister of Health on the Veterinary Good Clinical Practice

12.07.2012
This document concerns Veterinary Good Clinical Practice. ...

EMA: Concept paper on non-pharmacopoeial reference standards for herbal substances, herbal preparations and herbal medicinal products / traditional herbal medicinal products

05.07.2012
This concept paper applies to non-pharmacopoeial reference standards for herbal substances, herbal preparations and herbal medicinal products (HMPs) / traditional herbal medicinal products (THMPs). ...

EMA: Concept paper on extrapolation of efficacy and safety in medicine development

05.07.2012
This concept paper is intended to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine ...