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On 26 August 2019, China's National People's Congress passed the final amendments to the Drug Administration Law ("DAL"), which will take effect on 1 December 2019. The DAL was first enacted in 1984, then substantively ...
On 17 April 2019, the European Parliament approved, by a large majority, an amendment of the Regulation on Supplementary Protection Certificates ("SPCs").
So notes the Commission's report on competition enforcement in the pharmaceutical sector (2009-2017) published at the end of January 2019.
Following seminal “denigration” cases from the French, Danish and Italian competition authorities, our competition team looks into this new practice of exclusionary abuse.
Today in Actavis v ICOS the Supreme Court unanimously ruled that the ICOS patent for a Tadalafil dosing regime was invalid. Lord Hodge gave the only judgment, with Lady Hale, Lord Kerr, Lord Sumption and Lord Briggs in ...
The French so-called “anti-gift” provisions strictly frame the conditions under which companies in the health sector are allowed to provide advantages, in cash or in kind, to healthcare professionals ("HCPs”)
On 17 July 2020, the Hong Kong ("HK") Legislative Council enacted the Pharmacy and Poisons (Amendment) Ordinance 2020 ("Amendment Ordinance") that introduced specific provisions covering Advanced Therapy Products ...
The eighth edition of The Life Sciences Law Review covers a total of 33 jurisdictions, providing an overview of legal requirements of interest to pharmaceutical, biotechnology and medical device companies. The chapters ...
The French so-called “anti-gift” provisions strictly frame the conditions under which companies in the health sector are allowed to provide advantages, in cash or in kind, to healthcare professionals ("HCPs”).
Overall, the new DRR and AMMDP provide further clarity to the provisions of the new DAL. The obvious step toward improving the review and approval process, and the reduction in the need for onsite review for many ...