EMA: New Validation Criteria for Electronic Submissions into Effect Next Month
According to EMA's note, new version of the validation criteria for electronic applications for human medicines will come into effect on 1 September.
The European Medicines Agency has announced that a new version of the validation criteria for electronic applications for human medicines will come into effect on 1 September.
The Agency will be applying new electronic common technical document (eCTD) validation criteria (version 3.1) upon technical validation of all eCTD sequences received from this date. The Agency has agreed the new criteria with regulatory authorities in European Union (EU) Member States.
The Agency will release updated eCTD guidance for industry by the end of August.
The Agency advises pharmaceutical companies to familiarise themselves with the new criteria. Applications that do not adhere to the new requirements
Related News
-
News Panaxia's medical cannabis facility in Malta gains EU-GMP standard
This second facility gives the company a significant power multiplier for export capacity and geographical reach -
News CPHI Discover: Remote excipient audits are on the increase, but we must do more to develop novel excipients
Ahead of the session, Value Added Excipients to Unlock the Potential of APIs, at CPHI Discover on Thursday 18th May – global pharma’s largest ever virtual gathering – we spoke with one of the speakers, Dr Iain Moor... -
News Pharma Explained: What is Quality Risk Management & cGMPs?
Need clarity on determining your QA from your QbD and your cGMPs? You’re not alone! In our new Pharma Explained series from CPHI, we bring you clear cut definitions from industry experts on a myriad of Pharma Terms, delivered in bitesize video presenta... -
News Former FDA Commissioner lays out roadmap for building out excess capacity to deal with pandemic situations
Dr Scott Gottlieb shares insights into COVID-19 vaccine development, the upcoming US election and pharma pricing at the CPHI Festival of Pharma -
News Successful MHRA regulatory inspection for Scottish CMO Symbiosis
Inspection conducted remotely using video-conferencing and an online private document sharing platform. -
News Mylan and development partner win significant EPO ruling related to Copaxone
Decision clears legal pathway to expand access for patients living with multiple sclerosis in markets across Europe. -
News COVID-19 ushers in age of digital, flexible EU pharmaceutical regulation
The pandemic that has swept over the world in 2020 has caused huge disruption to the European pharmaceutical industry's regulatory procedures and supply chain management. But the crisis has also provided a platform for a learning process for the sy... -
News Europe's CHMP recommends suspension of medicines tested by Panexcell over flawed studies
The European Medicines Agency's human medicines committee (CHMP) has recommended the suspension of European marketing authorizations of generic medicines tested by Panexcell Clinical Laboratories at its site in Mumbai, India, citing irregularities in h...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance