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EMA survey of UK based pharmaceutical companies on Brexit plans

Eveline Van Keymeulen

Yesterday, the European Medicines Agency (EMA) announced its plan to consult all marketing authorisation holders of centrally authorised products that are located in the UK or who have an important part of their site operations in the UK on their plans to submit transfers, notifications or variations to their marketing authorisations in the context of Read More

Beyond the pill – are digital health deals set to spike?

Matthew Appleton

Transactions between big pharmaceutical companies and start-ups working on potentially highly disruptive but beneficial technologies in the healthcare space have not taken off as fast as some expected. That could be about to change. It probably wasn’t meant to take centre stage, but the small white circle on the arm of UK Prime Minister Theresa Read More

UPC ratification process in Germany put on hold following constitutional complaint

Joachim Feldges

In March 2017, a constitutional complaint was filed against both the German bill for ratifying the UPC Agreement and the UPC Agreement itself with the German Federal Constitutional Court (“Bundesverfassungsgericht”). Many stakeholders have been speculating on the grounds for this constitutional complaint. Now, the German Federal Constitutional Court has disclosed the main line of argumentation Read More

Falsifying drug regulatory submission may be a criminal offence in China

David Shen

In China’s latest effort to limit substandard drugs being approved using falsified clinical and non-clinical data, the Supreme People’s Court and the Supreme People’s Procuratorate jointly issued Judicial Interpretations that expressly provide that falsifying a drug regulatory submission may be a criminal offence which can be sanctioned with a penalty of up to 10 years imprisonment.  The Read More

BeneluxA collaboration joint pricing negotiations fail

Eveline Van Keymeulen

The first joint pricing negotiations for a medicinal product in the context of the BeneluxA collaboration with respect to health technology assessment and pricing and reimbursement have failed. On 23 May 2017, the Belgian Minister of Health announced that the Belgian National Institute for Health and Disability Insurance (RIZIV), joined by the Dutch competent authorities, Read More