“The European Medicines Agency (EMA) has updated its user guide for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector.”
The full story can be found at www.ema.europe.eu/news_and_events
Samarind RMS is always up to date with the latest regulatory guidelines, if you are a SME and want a solution for getting your pharmaceutical or medical device products to market contact us for a demonstration so we can show you a solution to your problems!
The EMA just released a new version 6.1 of the eCTD technical validation criteria, having corrected the MD5 checksums for two of the regional files. The good news is that the MD5 checksum did in fact exactly what it was supposed to do, i.e. protecting file integrity. Because of additions such as “EDQM” in eu-regional.xsl, eu-regional.dtd and eu-envelope.mod (eSubmission EU Module 1), the MD5 checksum changed. Although the checksum for eu-regional.dtd was altered in the eCTD validation criteria version 6.0, checksums for the other two seem to have been missed. This has now been corrected with version 6.1.
However, were these the only changes undertaken? Well, not quite. Read More
The Head of Medicinal Agencies (HMA) eSubmission Roadmap (November 2014) already highlighted that from 2016 all new veterinary Marketing Authorisation Application’s (MAA’s) for the Decentralised and Centralised Procedure (DCP and CP respectively) have to be in VNeeS format. Furthermore, from 2017 all veterinary submissions via the EU procedures need to be compliant with VNeeS. The recently released guideline prepared by the Veterinary Harmonisation Group (March 2015) provides some more details with regards to formats, file folder structure and naming conventions, coming into effect October 2015 already.
This highlights a number of challenges for the pharmaceutical industry providing veterinary medicines. Read More
The EMA ISO IDMP Information Day meeting that Ian and I attended yesterday (23rd June 2015) did not bring any surprises, but it did leave me thinking that implementing IDMP is actually achievable, unlike XEVMPD three years ago.
The good thing is that EMA seem to be trying to do it right this time. Read More
I’ve been re-reading the ISO IDMP implementation guides. These were distributed for comments towards the end of last year, and we expect revised documents for the main two (covering ISO 11615 – medicinal products and ISO 11616 – pharmaceutical products) soon.
Although I’m used to reading long technical documents – the XEVMPD and UDI ones for example – I hadn’t read an ISO implementation guide before, so I didn’t really know what to expect. I found the ISO IDMP standards themselves to be very good and I think I assumed that these would be of similar quality and usefulness. Unfortunately, in their draft state at least, I must admit I was disappointed.