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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.
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 ...
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.
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 ...
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 ...
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 ...
On 1 November 2018, the Standing Committee of the People's Congress in China ("NPC") announced two important draft documents for public consultation until 1 December 2018: (1) Drug Administration Law (Amendment Draft) ...
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 ...
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 ...
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 ...
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