FDA and EMA launch parallel scientific advice pilot program for complex generics

7 February 2024 - CDER’s Office of Generic Drugs and the EMA launched a voluntary pilot program to facilitate concurrent discussions ...

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FDA notes “continued growth” of Orbis collaborative review program, adds EMA as observer

1 November 2023 - There has been “continued growth” in the number of applications submitted to Project Orbis, and the ...

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CDER collaborates with global regulators on pharmaceutical quality assessments and inspections

28 July 2023 - The FDA and the EMA recently completed the first collaborative assessment of a proposed post-approval change ...

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FDA continues important work to advance medical products for patients with rare diseases

23 February 2023 - Patients with rare diseases are experts in their health condition. They provide a unique perspective, and ...

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EMA publishes minutes of bilateral EMA – EUnetHTA meeting (June 2022)

11 October 2022 - The chairs welcome participants to the first bilateral under the new Work Plan between EUnetHTA 21 ...

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NASWSI and Project Orbis - are they essentially the same?

7 September 2022 - We compare and contrast the two initiatives to bring new medicines to the market faster. ...

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International work-sharing - first medicines approved by all five Access Consortium regulators

2 September 2022 - The TGA has approved two new medicines as part of the Access New Active-Substance Work-Sharing Initiative. ...

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Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making

20 July 2022 - EMA has endorsed a joint statement calling for international collaboration to enable the generation and use ...

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US seeks pharmaceutical deal with Switzerland to fast-track FDA approvals

27 June 2022 - The Biden administration wants to reach a narrow sectoral trade agreement with the Swiss pharmaceutical industry, ...

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Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic

20 June 2022 - Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global ...

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FDA, EMA officials discuss impediments to cell and gene therapies

17 May 2022 - The US FDA's top biologics regulator said the use of a “playbook” or platform approach ...

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EMA and the EUnetHTA 21 consortium set priorities for their collaboration

12 April 2022 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a joint ...

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European medicines regulatory network adopts EU common standard for electronic product information

22 February 2022 - The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines ...

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Global regulators discuss path towards regulatory alignment on response to Omicron variant

13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...

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Access Consortium statement on COVID-19 medicines

14 December 2021 - Vaccines have played a critical role in fighting the COVID-19 pandemic. However, medicines can still play ...

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