News

The Common European Submission Platform

2012-12-05 The Heads of Medicines Agencies (HMA) is currently carrying out an ‘extended proof of concept’ for the Common European Submission Platform (CESP) project aimed at… Read More »

Suggestions for increasing generics use in Abu Dhabi

2012-12-03 This concluding article in a series of three suggests ways of improving the use of generics in Abu Dhabi. Potential benefits from a changed situationLimited… Read More »

Australian patients ‘very positive’ about generics

2012-11-30 A new survey shows 75% of Australians believe that the government should offer a price discount to consumers who choose generics. Generics are popular with… Read More »

Overview of research on safety and immunogenicity of biosimilars in 2012

2012-11-29 Period: January to August 2012  Biosimilars or ‘biosimilar medicinal products’ are medicinal products that are similar (but not identical) in terms of quality, safety and… Read More »

EMA publishes revised biosimilar Q&A document for patients

2012-11-28 On 27 September 2012 EMA published its revised Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public. The revised… Read More »

EMA to accept biosimilar reference medicines from outside EEA

2012-11-27 EMA announced on 28 September 2012 that it has adapted its guidance in order to make it easier for new biosimilar products to be approved… Read More »

Generics substitution: Ireland’s plan for reference pricing

2012-11-26 A bill that will be debated this autumn seeks to introduce generics substitution and reference pricing for medicines and medical and surgical appliances in Ireland.… Read More »

ABPI concerned about medicines misconceptions

2012-11-23 The Association of the British Pharmaceutical Industry (ABPI) represents innovative research-based biopharmaceutical companies in the UK. In a new survey commissioned by the association issues… Read More »

Italian Medicines Agency publishes concept paper on biosimilars

2012-11-21 The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) announced on 1 August 2012 the release of a concept paper on biosimilars. The purpose of the… Read More »

Poor quality pharma ingredients abound in China

2012-11-19 Lack of regulatory enforcement in China is allowing poor quality pharmaceutical ingredients to be sold to drug manufacturers with potentially dangerous or even fatal consequences… Read More »

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