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  1. Legal news
    06 September 2019
    China passed new amendments to the Drug Administration Law
    www.twobirds.com/en/news/articles/2019/global/china-passed-new-amendments-to-the-drug-administration-law

    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 ...

  2. Legal news
    08 May 2019
    Manufacturing and stockpiling waiver set to limit rights of holders of SPCs for medicines
    www.twobirds.com/en/news/articles/2019/global/manufacturing-and-stockpiling-waiver-set-to-limit-rights-of-holders-of-spcs-for-medicines

    On 17 April 2019, the European Parliament approved, by a large majority, an amendment of the Regulation on Supplementary Protection Certificates ("SPCs").

  3. Legal news
    05 February 2019
    "Effective enforcement of EU competition rules in the pharmaceutical law remains a matter of high priority…"
    www.twobirds.com/en/news/articles/2019/global/effective-enforcement-of-eu-competition-rules-in-pharmaceutical-law

    So notes the Commission's report on competition enforcement in the pharmaceutical sector (2009-2017) published at the end of January 2019.

  4. Legal news
    18 September 2019
    When does speaking badly about your competitors become a competition law problem?
    www.twobirds.com/en/news/articles/2019/global/when-does-speaking-badly-about-your-competitors-become-a-competition-law-problem

    Following seminal “denigration” cases from the French, Danish and Italian competition authorities, our competition team looks into this new practice of exclusionary abuse.

  5. Legal news
    27 March 2019
    Supreme Court holds Dosage Regime Patent Obvious
    www.twobirds.com/en/news/articles/2019/global/supreme-court-holds-dosage-regime-patent-obvious

    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 ...

  6. Legal news
    02 July 2019
    Transfer of value: amendments to the French “anti-gift” provisions by the draft Health Act
    www.twobirds.com/en/news/articles/2019/global/transfer-of-value-amendments-to-the-french-anti-gift-provisions-by-the-draft-health-act

    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”)

  7. Legal news
    17 August 2020
    Advanced Therapy Products Amendment - Hong Kong Pharmacy and Poisons (Amendment) Ordinance 2020
    www.twobirds.com/en/news/articles/2020/hong-kong/advanced-therapy-products-amendment-hong-kong-pharmacy-and-poisons-amendment-ordinance-2020

    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 ...

  8. Legal news
    06 May 2020
    Our UAE team contribute to the 8th edition of the Life Sciences Law Review
    www.twobirds.com/en/news/articles/2020/uae/our-uae-team-contribute-to-the-8th-edition-of-the-life-sciences-law-review

    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 ...

  9. Legal news
    18 June 2020
    Transfer of value in France: the long-awaited “anti-gift” decree has finally been published
    www.twobirds.com/en/news/articles/2020/france/transfer-of-value-in-france-the-long-awaited-anti-gift-decree-has-finally-been-published

    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”).

  10. Legal news
    24 July 2020
    China Updates Drug Registration Rules and the Measures for Monitoring Drug Production – Part 1
    www.twobirds.com/en/news/articles/2020/china/china-updates-drug-registration-rules-and-the-measures-for-monitoring-drug-production

    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 ...