Policies & Legislation

EMA criticized for change in data transparency plans

Home/Policies & Legislation | Posted 20/06/2014

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.

France to allow biosimilars substitution

Home/Policies & Legislation | Posted 21/02/2014

Pharmacists in France will now be allowed to substitute a biosimilar for the prescribed (reference) biological under certain conditions, including only when initiating a course of treatment and that the prescribing physician has not marked the prescription as ‘non-substitutable’.

WHO calls for better science-based regulations for biosimilars

Home/Policies & Legislation | Posted 13/06/2014

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

Home/Policies & Legislation | Posted 06/06/2014

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

EMA and FDA report on collaborative efforts

Home/Policies & Legislation | Posted 16/05/2014

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

Home/Policies & Legislation | Posted 25/04/2014

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

Home/Policies & Legislation | Posted 11/04/2014

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

Home/Policies & Legislation | Posted 04/04/2014

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

Home/Policies & Legislation | Posted 28/03/2014

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

Home/Policies & Legislation | Posted 21/03/2014

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

Home/Policies & Legislation | Posted 21/03/2014

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

Home/Policies & Legislation | Posted 14/03/2014

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

Home/Policies & Legislation | Posted 07/03/2014

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.

FDA and Health Canada streamline drug submissions

Home/Policies & Legislation | Posted 28/02/2014

The US Food and Drug Administration (FDA) and Health Canada have joined forces to launch the Common Electronic Submissions Gateway. Drug companies will be able to use the gateway to send drug authorization data online using a special dedicated channel of FDA’s existing system.

Washington State legislation on biosimilars

Home/Policies & Legislation | Posted 07/02/2014

Biologicals manufacturers represented by the Biotechnology Industry Association (BIO) and the Washington Biotechnology & Biomedical Association have welcomed proposed Washington State legislation that will support the substitution of interchangeable biological medicines.

Brazil to designate medicamentos similares as interchangeable

Home/Policies & Legislation | Posted 24/01/2014

Medicamentos similares (similar medicines) may soon be substituted with the reference drug in Brazil, under the latest initiative launched by the country’s National Health Surveillance Agency [Agência Nacional de Vigilância Sanitária, ANVISA].

EMA and FDA launch joint generics inspections

Home/Policies & Legislation | Posted 17/01/2014

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will work together to ensure the safety of generic medicines. It is hoped that streamlining the inspection process for generic drug applications will help consumers gain access to safe and effective generics.