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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
    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 ...

  4. 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 ...

  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
    03 September 2018
    New IP Act Passed in Australia: implementing Phase 1 recommendations of the Productivity Commission
    www.twobirds.com/en/news/articles/2018/australia/new-ip-act-passed-in-australia

    On 16 August 2018, the Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Bill 2018 (Bill) passed through both Houses of Parliament and will shortly come into force upon ...

  7. Legal news
    28 August 2018
    China: Regulatory updates on product-related license for API
    www.twobirds.com/en/news/articles/2018/china/regulatory-updates-on-product-related-license-for-api

    While more work needs to be done to bring the Chinese regulatory landscape up to the standards of other industry leading countries, as exemplified in the recent incidents concerning vaccines in the country, China has ...

  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
    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 ...

  10. Legal news
    09 April 2020
    COVID-19 (Temporary Measures) Act 2020: Legal circuit breaker
    www.twobirds.com/en/news/articles/2020/singapore/covid19-temporary-measures-act-2020-legal-circuit-breaker

    In our previous article (Temporary Relief for Inability to Perform Contractual Obligations due to the COVID-19 Situation in Singapore), we had highlighted that the Ministry of Law had on 1 April 2020 announced its ...