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  1. 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.

  2. Legal news
    20 June 2019
    China to accelerate the development of "Smart Supervision System" for drug and medical devices
    www.twobirds.com/en/news/articles/2019/global/china-to-accelerate-the-development-of-smart-supervision-system-for-drug-and-medical-devices

    The NMPA issued the Drug Smart Supervision Plan aiming to deepen the development of a drug supervision system embracing modern information technologies such as cloud computing, big data, and "Internet+" technologies.

  3. 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 ...

  4. Legal news
    03 September 2019
    China Expands Medical Devices Market Authorization Holder Pilot Project to 21 Provinces/Municipalities
    www.twobirds.com/en/news/articles/2019/global/china-expands-medical-devices-market-authorization-holder-pilot-project-to-21-provinces

    On 1 August 2019, the National Medical Products Administration ("NMPA") issued a notice to extend the pilot project of medical device registrant system (GUO YAO JIAN XIE ZHU (2019) No.33) ("Notice") to 21 ...

  5. Legal news
    07 November 2019
    Opening the gates for generics - E-prescribing requirements implemented in Australia
    www.twobirds.com/en/news/articles/2019/australia/opening-the-gates-for-generics-e-prescribing-requirements-implemented-in-australia

    The Australian Pharmaceutical Benefits Scheme (PBS) provides for and regulates government subsidies for the supply of certain medicines. A requirement to receive subsidised medicine under the PBS is that the medicine ...

  6. Legal news
    20 May 2021
    China patent linkage update - The patent registration platform is finally launched!
    www.twobirds.com/en/news/articles/2021/china/china-patent-linkage-update--the-patent-registration-platform-is-finally-launched

    On 18 May 2021, the Center for Drug Evaluation (“CDE”) of the National Medical Products Administration (“NMPA”) formally launched the Chinese Marketed Drug Patent Information Registration Platform ...

  7. Legal news
    06 July 2021
    China Patent Linkage News Flash (II) - The Supreme Court finalized the Patent Linkage Judicial Interpretations on 5 July 2021
    www.twobirds.com/en/news/articles/2021/china/the-supreme-court-finalized-the-patent-linkage-judicial-interpretations-on-5-july-2021

    The Chinese Supreme Court (the “SPC”) issued the “Provisions on Several Issues Concerning the Application of Law in the Trial of Civil Cases of Patent Disputes Related to Drugs Applied for Market Authorization” (the ...

  8. Legal news
    05 July 2021
    News flash - Patent Linkage Implementing Measures came into force in China on 4 July 2021
    www.twobirds.com/en/news/articles/2021/china/patent-linkage-implementing-measures-came-into-force-in-china-on-4-july-2021

    On 4 July 2021, the National Medical Products Administration (the “NMPA”) and the China Intellectual Property Administration (the “CNIPA”) published the “Implementing Measures for Drug Patent Dispute Early Resolution ...

  9. Legal news
    13 May 2021
    China Accelerates Medical Device Regulatory Reform with new Medical Device Regulations
    www.twobirds.com/en/news/articles/2021/china/china-accelerates-medical-device-regulatory-reform-with-new-medical-device-regulations

    On 18 March 2021, the State Council of China issued the new Medical Device Administration Regulations (“MDAR 2021”), which will come into effect on 1 June 2021. The new MDAR 2021 will require changes to related ...

  10. Legal news
    11 February 2021
    Patent Linkage Update in China - A Pre-Chinese New Year Gift
    www.twobirds.com/en/news/articles/2021/china/patent-linkage-update-in-china-a-prechinese-new-year-gift

    On 9 February 2021, the China National Intellectual Property Administration (“CNIPA”) issued the “Administrative Adjudication Measures for Drug Patent Dispute Early Resolution Mechanism (Draft for Public Opinions)” ...