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  1. Legal news
    16 August 2019
    China Released its Second Draft DAL Amendments to the Drug Administration Law
    www.twobirds.com/en/news/articles/2019/china/life-sciences-and-healthcare-newsletter-aug-2019

    On 20 April 2019, the Standing Committee of the National People's Congress ("NPC") held a second deliberation meeting to discuss the Draft Amendments to Drug Administration Law ("Second Draft DAL Amendments"). A week ...

  2. Legal news
    03 August 2020
    China Updates Drug Registration Rules and the Measures for Monitoring Drug Production – Part 2
    www.twobirds.com/en/news/articles/2020/china/china-updates-drug-registration-rules-and-the-measures-for-monitoring-drug

    The restating of the expedited review pathways, and the recently published work procedures, appear to be a step toward improving a process that has seemingly changed numerous times over the years.

  3. 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 ...

  4. Legal news
    09 April 2020
    China Imposes New Export Restrictions for COVID-19 Medical Products
    www.twobirds.com/en/news/articles/2020/china/china-imposes-new-export-restrictions-for-covid-19-medical-products

    On 31 March 2020, the “Ministry of Commerce, General Administration of Customs and the National Medical Product Administration (NMPA) issued Notice No. 5 of 2020 – Notice on the Orderly Conducting of Medical Materials ...

  5. Legal news
    04 December 2020
    Supplemental Protection Period for pharmaceutical patents in China - Update
    www.twobirds.com/en/news/articles/2020/china/supplemental-protection-period-for-pharmaceutical-patents-in-china---update

    On 27 November 2020, the China National Intellectual Property Administration (“CNIPA”) issued the draft Implementing Regulations of the PRC Patent Law (“Draft Amendments for Implementing Regulations”) for public ...

  6. Legal news
    22 October 2020
    China passes Patent Law Amendments 2020 and introduces Drug Patent Linkage and Supplemental Protection Period systems
    www.twobirds.com/en/news/articles/2020/china/china-passes-patent-law-amendments-2020-and-introduces-drug-patent-linkage-and-supplemental

    On 17 October 2020, China's Standing Committee of the National People's Congress ("NPC") passed the amendments for the Patent Law of China ("Patent Law Amendments 2020"), which will come into effect on 1 June 2021.

  7. Legal news
    04 November 2020
    Chinese patent linkage system - the Chinese Supreme Court issues Draft Judicial Interpretations
    www.twobirds.com/en/news/articles/2020/china/chinese-patent-linkage-system---the-chinese-supreme-court-issues-draft-judicial-interpretations

    As the patent linkage provisions are new for China, the Draft Judicial Interpretations provide some guidance on how the system will be implemented in practice. The Draft Judicial Interpretations are open for public ...

  8. 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.

  9. 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 ...