Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.
The medical device tech firm is poised to assist manufacturers in navigating the new European Medical Device Regulation, which goes into effect this week.
A lease agreement has been signed for the EMA to move into tailor-made premises in Amsterdam, with staff set to begin working from the space in January.
Representatives from the EMA and China’s NMPA convene to share expertise on GMP for APIs, GCP standards, and on the environmental impact of manufacturing.
UK government signs freight capacity contracts to mitigate the risk that trade disruption will stop medicines from reaching patients related to a potential no-deal Brexit.
Though the utilization of biosimilars in Europe is high, a report on the practices of eight countries suggests that more can be done to foster competition and remove barriers to entry.
In response to the UK government’s publication of potential ramifications of a no-deal Brexit, the ABPI responded that the pharma industry needs more details on mitigation strategies.
A report from the EUIPO demonstrated that a shift in the focus of counterfeited goods to include pharmaceutical products has caused significant loss of sales and employment.
European generics industry faces opposition while pushing for the SPC manufacturing waiver to be altered so it allows for the production of drugs under patent for non-EU countries.
As negotiations continue and discussions on ‘hard Brexit’ outcomes build, few have considered the impact on European industry, one organisation suggests.
With plans to “futureproof” its service offerings, Wasdell is investing €30m in a testing and distribution facility in Ireland – a growing market and gateway into Europe and North America, says CEO.
Preparations for an “unlikely” ‘no deal’ Brexit are underway in the UK, with the government instructing pharmaceutical companies to build their medicine reserves before March 2019.
Ignoring pediatric considerations is no longer an option for the development of new medicines – though clinical trials in children are still not widely accepted by society, explains industry executive.
An EMA survey has found that 42% of businesses, with an important step in their regulatory processes occurring in the UK, are not adequately prepared to retain marketing authorisation post-Brexit.
Swiss pharmaceuticals company Roche yesterday said its vitamins and
fine chemicals unit, recently sold to DSM, fully complies with new
requirements for vitamin E issued this month by the Netherlands.
