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European Commission adopts revised definition of “similar medicinal product”

Eveline Van Keymeulen

Yesterday, the European Commission adopted Regulation 2018/781 amending Regulation (EC) No 847/2000 as regards the definition of the concept “similar medicinal product” in the context of the Orphan Medicines Regulation.  The Regulation extends the definition of “similar active substance”, by clarifying that “[i]f the principal molecular structural features cannot be fully established, the similarity between Read More

Dutch CCMO publishes information on impact of GDPR on clinical research

Iradj Nazaryar

On 13 April 2018, the Dutch Central Committee on Research Involving Human Subjects (CCMO) published a Q&A on the impact of the upcoming General Data Protection Regulation ((EU) 2016/679) (GDPR) on clinical research. According to the CCMO, to process the personal data of current or past participants of research that comes under the Dutch Clinical Read More

China: Update on IP and regulatory developments

David Shen

The Chinese Food and Drug Administration (CFDA) recently released a number of new guidelines and regulations to implement the directives from the Central Government Opinion released on 8 October 2017 (see our earlier post: Chinese medicinal product approval reform announced). These new guidelines and regulations represent the efforts made by CFDA to promote innovation in the Chinese Read More

Life Sciences IPOs – 5 things to consider

Michael Bloch

After spending all day last Wednesday at Biotech & Money’s IPO workshop presenting and talking to Life Sciences start ups about their IPO plans, we thought it might be interesting to bring together some of our key thoughts on IPO preparedness. Companies thinking about an IPO can never start planning too early.  IPO planning and Read More

EMA survey of UK based pharmaceutical companies on Brexit plans

Jacqueline Bore

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