Regulatory & compliance

Federal Circuit upholds finding that Broad Institute CRISPR patents in plant and animal cells do not overlap with UC Berkeley patents

Jacqueline Bore

CRISPR-Cas9 is a remarkable gene editing technology which has the potential to revolutionise the development of medicines, particularly those for genetic diseases and cancer. Pharmaceutical companies have been quick to partner with innovators who have begun to find ways to commercialize CRISPR-Cas9, both as a research tool and as a route to the development of Read More

UK Department for Health and Social Care publishes an initial code of conduct for use of digital technology

Emma Keeling

As big data continues to be big news and data protection law continues to evolve, it is timely that the Department for Health and Social Care (the Department) has published a code of conduct relating to the use of data-driven health and care technology (the Code). Published in its initial form on Wednesday, the code Read More

New directive on GMP transposed into Belgian law

Tine Carmeliet

On 20 July 2018, the Royal Decree of 27 June 2018, which implements Commission Directive 2017/1572 as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (GMP Directive), was published. The decree should have been implemented on 31 March 2018, when the GMP Directive entered into force. While the Read More

France publishes call for projects on incentive mechanisms to favour hospital prescription of biosimilars

Eveline Van Keymeulen

On 17 August 2018, an order concerning a national experiment to incentivise hospital prescription of similar biological drugs (biosimilars) was published. The experiment is part of the health innovation programme provided for in Article L.162-31-1 of the Social Security Code and results from the 2018 Social Security Financing Bill, which allows the experimentation of novel methods Read More

Getting ready for the EU MDR: New guidance documents available for manufacturers

Eveline Van Keymeulen

During the summer months of July and August, the European Commission has published five documents aimed at guiding manufacturers and other economic operators through the changes implemented by the EU Medical Devices Regulation (MDR) and the EU In-Vitro Diagnostic Medical Devices Regulation (IVDR). Both regimes will be fully applicable on 26 May 2020 and on 26 Read More