UK – UK to introduce new regulatory framework for point of care manufacturing
The framework will ensure that there are no regulatory barriers to innovative manufacturing and that these products have the same assurances of safety, quality...
International – ICH adopts Q9 guidelines on quality risk management
The International Council for Harmonisation (ICH) has adopted a revised version of its Q9 guideline that aims to improve current quality risk management (QRM)...
UK – European Commission Decision Reliance Procedure (ECDRP) extension
The European Commission Decision Reliance Procedure (ECDRP) has been extended to 31 December 2023. From 1 January 2024 a new international recognition framework will be in...
USA – FDA finalizes guidance on cannabis clinical research
The US Food and Drug Administration has finalized a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs...
USA – FDA officials impart lessons learned from quality management maturity pilots
The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or...
UK – NICE recommends Takeda’s Ninlaro triplet regimen
Therapy involves patients living with relapsed or refractory multiple myeloma
Takeda has announced that the National Institute for Health and Care Excellence (NICE) has recommended...
UK – NICE recommends PTC Therapeutics’ Translarna reimbursement
PTC Therapeutics has announced that the National Institute for Health and Care Excellence (NICE) has issued a final evaluation document recommending Translarna.
It involves reimbursement...
USA – FDA issues draft guidance on mpox drug development
In a much-anticipated draft guidance issued on Thursday, the US Food and Drug Administration (FDA) said that unlike smallpox therapeutics, treatments for mpox cannot...
USA – Pharma groups say ICH guideline on viral safety evaluation needs to incorporate...
US pharmaceutical industry groups endorsed the major principles of the International Council for Harmonization’s (ICH) Q5A(R2) guideline on viral safety of biotechnology products but...
UK – Amvuttra recommended by NICE for amyloidosis
Alnylam has welcomed a draft decision from the National Institute for Health and Care Excellence (NICE) recommending the use of Amvuttra on the NHS...
