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Policies & Legislation

Europe–Japan cooperation on generics and biosimilars regulation

Japanese and European generics groups have met to discuss increase regulatory cooperation between the two regions.

EMA and FDA report on collaborative efforts

Key initiatives being undertaken between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) were discussed at a bilateral meeting which took place in London, UK, from 31 March to 1 April 2014.

Delaware passes biosimilars substitution law

Delaware has become the latest US state to pass a law allowing substitution of a biosimilar for an originator biological, but with certain restrictions.

Australian price cuts make PBS affordable

The price cuts for 121 medicines supplied through Australia’s Pharmaceutical Benefits Scheme (PBS) have made the PBS sustainable, according to Medicines Australia, a group that represents originator manufacturers.

Bill proposes extension of patents for new uses of biologicals

A new bill, introduced in the US House of Representatives on 24 March 2014, proposes allowing patent owners to extend terms for certain biological patents if they are approved for new indications.

Indiana biosimilars substitution bill becomes law

Indiana Governor Mike Pence signed into law on 25 March 2014 legislation that will allow pharmacists to substitute biosimilars that the US Federal Drug Administration (FDA) has approved as interchangeable with an originator biological under certain conditions.

Obama pushes for 7-year exclusivity for biologicals

US President Barack Obama has announced proposals for fiscal year 2015 which aim to increase the availability of generics and biosimilars.

Proposal in Brazil to exempt medicines from tax

The Brazilian Government announced on 9 February 2014 that it is setting up a committee to evaluate whether to exempt medicines from tax in the country.

EMA and FDA extend quality collaboration

The European Medicines Agency (EMA) announced on 6 March 2014 that as of 1 April 2014 EMA and the US Food and Drug Administration (FDA) have agreed on a two-year extension of their joint pilot programme for the parallel evaluation of quality elements, known as quality-by-design (QbD), for applications submitted to both agencies.

European trade organizations worried about pharmacovigilance fees

Some of Europe’s major trade associations have expressed their concerns over fees being proposed by the European Medicines Agency (EMA) as part of new European Union (EU) pharmacovigilance rules.

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