EN PL

News

RAPS: EU Regulators Concerned About Drug Data Fraud by Indian Company

11.12.2014
European regulatory officials have expressed concern that dozens of medicines may have been approved in the EU based on fraudulent data conducted by a contract testing facility in Hyderabad, India. ...

URPL: nformation of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of December 10, 2014 concerning amendment of fees related to marketing authorization of a medicinal product since January 1, 2015.

11.12.2014
This document is an information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of December 10, 2014 concerning amendment of fees related ...

EMA: Draft reflection paper on the use of patient reported outcome (PRO) measures in oncology studies

07.08.2014
The importance of the patient’s point of view on their health status is fully acknowledged and such information may in principle be used in drawing regulatory conclusions regarding treatment ...

EMA: European Medicines Agency releases best practice guidance on parallel scientific advice with health-technology-assessment bodies

15.05.2014
The European Medicines Agency (EMA) has published for public consultation best practice guidance for pilot parallel scientific advice procedures involving the EMA and health-technology-assessment ...

GMP: PIC/S revises Annex 14 for Medicinal Products derived from Human Blood or Plasma

27.02.2014
The document provides specific guidance on GMP practices related to the collection, processing, storage and transport. ...

MHRA: Marketing authorisations: Types of application

27.02.2014
There are several alternative procedures to choose from depending on which countries the product is going to marketed in and the type of medicine. ...

EMA: Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure

13.06.2013
The current update of this guideline provides further recommendations on the requirements for acceptability and submission of proposed (invented) names of medicinal products processed through the ...

GMP: New Guidance for Recall of IMPs

21.02.2013
The European Commission DG Health & Consumers has published the revised EU-GMP Chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely. Whereas the ...

EMA: Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies

31.01.2013
From 10 January 2013, marketing authorisation holders have the obligation to comply with the format of the final study report for non-interventional post-authorisation safety studies (PASS), as ...

EMA: Draft European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) reflection paper on collecting data on consumption of antimicrobial agents per animal species, on technical units of measurement and indicators for reporting consumption of a

03.01.2013
The main aim of this reflection paper is to discuss how to establish systems for the collection of reliable and standardised data on consumption of antimicrobial agents by animal species for the ...