Human medicines: highlights of 2021

15 February 2022 - In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance ...

Read more →

EMA starts safety review of Janus kinase inhibitors for inflammatory disorders

11 February 2022 - EMA’s safety committee, PRAC, has started a review of the safety of Janus kinase (JAK) inhibitors ...

Read more →

National Medicines Policy too important to be rushed before Federal Election

10 February 2022 - Following consultation with members – and heeding the concerns of the Consumers Health Forum and patient ...

Read more →

Review of the National Medicines Policy – consultation on draft National Medicines Policy extended

8 February 2022 - The consultation period on the draft NMP was due to close on Wednesday 16 February 2022.  ...

Read more →

Medicines Australia calls for new National Medicines Policy to be pushed back until after the federal election

4 February 2022 - Medicines Australia is today calling for the new National Medicines Policy to be pushed back until ...

Read more →

ABPI analysis on NICE’s changes for evaluating new medicines: next steps

31 January 2022 - NICE has published a new Manual, which sets out how the latest medicines and health technologies ...

Read more →

Review of the National Medicines Policy – consultation on the draft closes 16 February 2022

2 February 2022 - Since August 2021, the Committee has heard from nearly 200 stakeholders through bilateral interviews and virtual group ...

Read more →

NICE publishes new combined methods and processes manual and topic selection manual for its health technology evaluation programmes

31 January 2022 - Changes to the way medicines and other health technologies are evaluated by NICE have now been incorporated ...

Read more →

How are child specific utility instruments used in decision making in Australia? A review of Pharmaceutical Benefits Advisory Committee public summary documents.

28 January 2022 - Measuring and valuing health-related quality of life in children can be challenging but is an important component ...

Read more →

National Medicines Policy Review – publication of submissions

21 January 2022 - On 30 August 2021, the National Medicines Policy Review Committee invited submissions to support the Review of ...

Read more →

NICE moves: increased accessibility and flexibility for health tech

19 January 2022 - NICE also aims to make strides in digital, genomic and antimicrobial technologies ...

Read more →

UK’s NICE to launch sweeping changes to drug assessments to be faster, more agile

19 January 2022 - The health technology assessment body has been under pressure from drugmakers and patient groups for years to ...

Read more →

Early benefit assessment for new drugs 2021: G-BA sets a record with 146 completed procedures

10 January 2022 - At the beginning of the year, the Federal Joint Committee (G-BA) took stock of its assessment of ...

Read more →

TGA in review (2021)

19 January 2022 - Using a liberal definition of what constitutes a 'new medicine', we have determined the TGA approved ...

Read more →

FDA approved more first in class drugs, gave more accelerated approvals in 2021

7 January 2022 - The US Food and Drug Administration’s Center for Drug Evaluation and Research approved 50 new drug therapies ...

Read more →