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Archive for category: Blog

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Updated SME user guide now available

“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

Source:  www.ema.europe.eu

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!

 

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ICH E11(R1) draft Guideline reaches Step 2b of the ICH Process

“The ICH E11(R1) draft Addendum Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 2b of the ICH Process in October 2016 and now enters the consultation period (Step 3). 

This Addendum is proposed to address new scientific and technical knowledge advances in pediatric drug development.”

 

The ICH E11 guideline, created in 2000, is progressing in its process of revision, the original scope of the guideline is unchanged but will now take on board the needed clarification regarding paediatric drug development. The addendum applies to

  • Section 2 on ETHICAL CONSIDERATIONS,
  • Section 4 on AGE CLASSIFICATION AND PEDIATRIC SUBGROUPS INCLUDING NEONATES,
  • Section 7 on PEDIATRIC FORMULATIONS,
  • Section 3 on COMMONALITY OF SCIENTIFIC APPROACH FOR PEDIATRIC DRUG DEVELOPMENT PROGRAMS
  • Section 5 on APPROACHES TO OPTIMIZE PEDIATRIC DRUG DEVELOPMENT

 

For full information please follow the link to the E11 (R1) ICH harmonised guideline http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E11/ICH_E11_R1_Step_2_25Aug2016_Final.pdf

 

Source: http://www.ich.org/ichnews/newsroom/read/article/ich-e11r1-draft-guideline-reaches-step-2b-of-the-ich-process.html

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eCTD EU M1 v3.0 – A somewhat hasty implementation?

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

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Regulatory Information Management (RIM) and VNeeS for Veterinary

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

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Underwhelmed by the draft ISO IDMP implementation guides

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.
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