WHO Panel Calls for Global Gene Editing Registry

International – WHO Consults on QMS Guideline for Regulators

The World Health Organization (WHO) in January released for consultation a draft of its upcoming guideline on implementing quality management systems (QMS) for national...
WHO Panel Calls for Global Gene Editing Registry

International – WHO Warns of Falsified Leukemia Drug in Supply Chain

The World Health Organization issued a warning about fake versions of Iclusig (ponatinib) that have been circulating throughout Europe and the Americas. A wholesaler in...
Differences and similarities between FDA 21 CFR Part 820 and ISO 13485

International – Differences and similarities between FDA 21 CFR Part 820 and ISO 13485

ISO 13485:2016 is a voluntary standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the...
CHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited metabolic disease

International – Two additional countries to benefit from EU-US mutual recognition agreement for inspections

In February 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at...
Report finds NICE’s routine appraisals need reform

International – NICE and Canadian counterpart to offer joint advice service

The service will offer guidance that will help pharma develop value-based evidence by providing feedback on the company’s clinical and economical evidence generation plans. Feedback...
Biosimilar use may increase with scrutiny of high drug prices

International – Biosimilar use may increase with scrutiny of high drug prices

Complex biologic medications that are made in living cells are some of the most expensive drugs on the market, but expiring patents on biologics...
Drug price disclosures could influence consumer thinking, study finds

International – Drug price disclosures could influence consumer thinking, study finds

The Trump administration's proposal to require pharmaceutical companies to list drug prices in television ads would have a profound impact on the way consumers...
Industry Comments on ICH Product Lifecycle Management Guideline

International – Industry Comments on ICH Product Lifecycle Management Guideline

The European Medicines Agency (EMA) on Friday released comments gathered during its public consultation for the International Council for Harmonisation's (ICH) draft guideline on...
Shire Raises ‘Substantial Concerns’ About ICH Guidelines in Feedback to EMA

International – ICH Offers Updates on Guidelines, Working Groups

In addition to updates on how ICH regulatory members are implementing ICH guidelines, the ICH Assembly at its meeting in Charlotte, NC, on 14-15...
The chapter on water: micro determination (2.5.32.) has been revised in the Ph. Eur. Supplement 9.8.

International – L’EDQM et l’ANVISA signent un accord sur la qualité des médicaments

La Direction européenne de la qualité du médicament & soins de santé (EDQM) et l’ANVISA, l’agence brésilienne de surveillance sanitaire, ont annoncé aujourd’hui avoir...

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