New pharmaceutical law promotes generics in Chile

2012-09-21 In July 2012, a new pharmaceutical law was introduced in Chile. The new law aims to regulate generics bioequivalence in the country as well as… Read More »

EMA finalises pharmacovigilance guidance

2012-09-19 EMA announced on 25 June 2012 the release of the finalised versions of seven new guideline modules outlining good pharmacovigilance practices (GVPs) to assist sponsors… Read More »

India releases draft ‘similar biologic’ guidelines

2012-09-17 India has released regulatory guidelines outlining a simple abridged procedure for evaluation of ‘similar biologics’ which have been approved and marketed in India, Europe or… Read More »

EMA responds to questions over biosimilar comparability

2012-09-12 EMA has responded to questions regarding its comprehensive biosimilar regulatory pathway. The pathway, which includes the need for new clinical trials and comparability studies that… Read More »

Guidelines for substitution of generics in The Netherlands

2012-09-03 Marketed medicines that have passed bioequivalence testing should in general be substitutable. The Royal Dutch Pharmacists Association (KNMP) has published professional guidelines for community pharmacies… Read More »

Biosimilars policies in Italy

2012-08-31 According to the 2011 report by Rovira et al., biosimilars commercialised in Italy show a low penetration both in the total market (0.01%) and in… Read More »

EU guidelines for biosimilars

2012-08-29 The regulatory body for approval of medicines in the EU is EMA. The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical… Read More »

WHO guidelines on biosimilars: case studies and discussion highlights

2012-08-27 The experiences and progress of different countries in implementing WHO guidelines on evaluating biosimilars were the focus of a workshop hosted jointly by WHO and… Read More »

EMA opens up access to reports on suspected drug side effects

2012-08-24 In its commitment to transparency, EMA, on 31 May 2012, opened up access to reports on suspected drug side effects. The database contains reports on… Read More »

EMA revised guideline on quality of biosimilar medicines open for comments

2012-08-22 EMA announced on 31 May 2012 that it had released a revised guideline for public consultation describing how pharmaceutical companies should address the quality aspects… Read More »

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