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Policies & Legislation

Companies required to update information on drugs

The European Medicines Agency (EMA) announced that as of 16 June 2014 marketing authorization holders would be required to update the information on medicines authorized in the European Union.

EMA changes transparency plans to increase access to data

The European Medicines Agency (EMA) has done an about-turn on its data transparency plans after the agency’s draft on the conditions of use for the EMA interface were criticized for limiting access to clinical trials data.

Massachusetts governor signs biosimilars substitution bill

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

Court rules Canadian drug regulators cannot control generics' prices

Canada’s Patented Medicine Prices Review Board (PMPRB) has been told that it has no jurisdiction over the pricing of generics.

EMA criticized for change in data transparency plans

New Legislation approved by the European Parliament on 2 April 2014 aims to increase transparency with respect to clinical trials by making the results publicly available. The Clinical Trials Regulation, which is expected to take effect in 2016, will require the results of all new clinical trials to be published within a year of the trial ending. The way, however, that the European Medicines Agency (EMA) is proposing to make this data available has been criticized.

WHO calls for better science-based regulations for biosimilars

The sixty-seventh World Health Assembly (WHA) of the World Health Organization (WHO) closed on 24 May 2014, after adopting more than 20 resolutions on public health issues of global importance, one of which calls for better science-based regulations for biosimilars.

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.

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