On July 14, 2022, the European Commission (“EU Commission”) published a proposal to adopt an EU-wide Regulation on standards of quality and safety for substances of human origin intended for human application...more
Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more
2/9/2022
/ Clinical Trials ,
Data Privacy ,
Deadlines ,
Disclosure Requirements ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Life Sciences ,
Member State ,
New Regulations ,
Proposed Regulation ,
Reporting Requirements ,
UK
This year – 2022 – may finally be the year that the effort to modernize safety standards in the U.S. for cosmetics and other personal care products, which has been ongoing since 2013, comes to fruition. If so, the new...more
1/27/2022
/ Best Practices ,
Cosmetics ,
EU ,
European Commission ,
Food and Drug Administration (FDA) ,
Hazardous Substances ,
Personal Care Products ,
PFAS ,
Preemption ,
Product Labels ,
Product Recalls ,
Proposition 65 ,
REACH ,
State Bans ,
Toxic Chemicals
On 23 September 2020, in a landmark case, Medac v Commission, the trial-level General Court (“GC”) of the European Union (“EU”) annulled the decision of the European Commission (“EU Commission”) that had withdrawn the orphan...more
The European Commission (Commission) has released a Staff Working Document concerning its joint evaluation of the Orphan Regulation and the Paediatric Regulation (collectively, the Regulations) (Joint Evaluation) and an...more
In March, most European Union (‘EU’) countries ordered some form of lockdown and adopted many national measures to address or prevent issues raised by COVID-19. The health crisis pushed national authorities to focus on their...more
The European Commission ("Commission") presented the results of the stakeholders’ consultation on its "Note on Handling of Duplicate Marketing Authorisation Applications" ("Note on Duplicates") during the Pharmaceutical...more