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.

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 ...

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.

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 ...

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 ...

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 ...

25 January 2019
Implications on the Draft Amendment to the Drug Administration Law and the Draft Healthcare Law in the Pharmaceutical industry in China
www.twobirds.com/en/news/articles/2019/china/draft-amendment-to-drug-administration-law-and-draft-healthcare-law

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) ...

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 ...

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 ...

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 ...