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  1. Legal news
    02 April 2020
    A cure for COVID-19? – Don’t make the claim unless it is true.
    www.twobirds.com/en/news/articles/2020/china/a-cure-for-covid-19-dont-make-the-claim-unless-it-is-true

    Preferred summary The worldwide COVID-19 pandemic has led to a scramble for pharmaceutical and medical devices which can prevent or treat COVID-19 infections. Currently there is no vaccine or treatment for COVID-19 ...

  2. Legal news
    24 July 2019
    When do clinical trial consent disclosures render a patent invalid?
    www.twobirds.com/en/news/articles/2019/australia/when-do-clinical-trial-consent-disclosures-render-a-patent-invalid

    In the recent case of InterPharma Pty Ltd v Hospira Inc (No 5) [2019] FCA 960 the Australian Federal Court has given patentees guidance as to novelty preserving practice in the conduct of clinical trials.

  3. 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 ...

  4. Legal news
    02 February 2021
    COVID-19 – Australian response to regulation of medical devices
    www.twobirds.com/en/news/articles/2020/australia/covid-19-australian-response-to-regulation-of-medical-devices

    In response to the COVID-19 pandemic, the Australian Federal Minister for Health has exercised his power under section 41GS of the Therapeutic Goods Act 1989 (Cth) (the Act) to exempt certain medical devices from the ...

  5. Legal news
    11 May 2020
    Australia: While COVID-19 lockdown restrictions ease enforcement of advertising restrictions for therapeutic goods tighten
    www.twobirds.com/en/news/articles/2020/australia/australia-while-covid-19-lockdown-restrictions-ease-enforcement-of-advertising-restrictions

    The Therapeutic Goods Administration (TGA) has been monitoring and taking action against individuals and companies capitalising on the current pandemic to market and sell products that claim to prevent or cure COVID-19.

  6. Legal news
    15 September 2020
    Consultations open for the proposed Information Standard for country of origin labelling of complementary medicines
    www.twobirds.com/en/news/articles/2020/australia/consultations-open-for-the-proposed-information-standard

    The Australian Government is currently inviting consumers and industry participants to provide feedback on key provisions of the proposed Information Standard for manufacturers of complementary medicines.

  7. Legal news
    16 September 2020
    NMPA and CNIPA issue Draft Patent Linkage Measures in China
    www.twobirds.com/en/news/articles/2020/china/nmpa-and-cnipa-issue-draft-patent-linkage-measures-in-china

    On 11 September 2020, the National Medical Products Administration ("NMPA") and the China National Intellectual Property Administration ("CNIPA") issued the draft "Implementing Measures for Drug Patent Dispute Early ...

  8. Legal news
    31 December 2020
    Medical Device UDI System Goes Live in China on 1 January 2021
    www.twobirds.com/en/news/articles/2020/china/medical-device-udi-system-goes-live-in-china-on-1-january-2021

    Those in the medical device industry will be familiar with the Unique Device Identification (“UDI”) system for medical devices. While it has been a global discussion piece for many years, the timeline for implementation ...

  9. Legal news
    07 May 2020
    Are you exporting or importing COVID-related PPE from China? Here is what you need to know.
    www.twobirds.com/en/news/articles/2020/china/are-you-exporting-or-importing-covid-related-ppe-from-china-here-is-what-you-need-to-know

    If you are in the business of exporting or importing Personal Protective Equipment (PPE) or medical equipment from China during this COVID-19 pandemic, you need to be aware of the latest export requirements introduced ...

  10. Legal news
    07 July 2020
    China releases Latest Draft Amendments to Patent Law
    www.twobirds.com/en/news/articles/2020/china/china-releases-latest-draft-amendments-to-patent-law

    The draft amended Patent Law contains several other new provisions in addition to the Patent Linkage and the SPP provisions, such as the draft Article 24 which proposes a six month grace period of novelty for an ...