Clinical Trial Regulation : Update

Europe – Guideline on the content, management and archiving of the clinical trial master...

Trial master file (TMF) plays a key role in the successful management of a trial by the investigator/institutions and sponsors. The essential documents and data...
International scientific guidelines adopted in Australia

Europe – Guideline on Active Substance Master File Procedure

The main objective of the Active Substance Master File (ASMF) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow...
Ajovy bags NICE approval

UK – NICE appraisal fees to be introduced despite opposition

The fee for single technology appraisals (STAs) and highly specialised technology appraisals (HTAs) will be £126,000 ($158,500, €140,400). The government has made a major concession...
Clinical Trial Regulation : Update

Europe – Draft guideline on quality and equivalence of topical products

The guideline relates to locally applied and locally acting medicinal products for cutaneous use and is also relevant for other medicines e.g. preparations for...
Guidelines For Mobile Health Applications – Examining The Xcertia Guidelines' Initial Release

Europe – Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Executive summary A growing number of regulatory submissions include physiologically based pharmacokinetic (PBPK) models that require the use of specialised software platforms. While PBPK modelling...
NICE rejects NHS funding for Tegsedi, Onpattro

UK – NICE rejects NHS funding for Tegsedi, Onpattro

Preliminary highly specialised technologies guidance on Akcea Therapeutics’ Tegsedi (inotersen) and Alnylam Pharmaceuticals’ Onpattro (patisiran) conclude that both therapies offer benefits for people with...
Ph. Eur. 10th Edition - Now available!

Europe – Nouvelle ligne directrice de l’EDQM « Comment lire un CEP »

L’EDQM a élaboré la ligne directrice « How to read a CEP » avec l’objectif de décrire en détail l’information transmise sur les Certificats de conformité...
WHO develops classification system for protecting efficacy of antibiotics

UK – Pharma calls for more detail on plan for post Brexit meds access

The move follows publication of an open letter by Health Secretary Matt Hancock touching on the government’s preparations in the event that an agreement...
Ajovy bags NICE approval

UK – NICE turns down Opdivo/Yervoy combo for kidney cancer

Explaining the decision, the Institute said that while clinical trial evidence shows that the Opdivo (nivolumab)/Yervoy (ipilimumab) combination “is substantially more effective” than Pfizer’s...
NICE grants Lynparza expansion for advanced ovarian cancer

UK – NICE OKs NHS funding for Gilead’s CAR T-cell therapy

The National Institute for Health and Care Excellence says the treatment can be funded via the Cancer Drugs Fund for adults with relapsed or...

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