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Archive for month: December, 2016


Guidance for SMEs using ISO 9001 for quality management just released

ISO’s essential guide for SME’s wishing to implement a quality management system (QMS) has just been updated, providing practical advice and concrete examples tailored specifically for small businesses.

ISO 9001:2015 for Small Enterprises  What to do? has just been updated to align with the newly revised version of one of ISO’s most popular standards, ISO 9001, Quality management systems – Requirements, updated in 2015.

The handbook was written by a group of experts from ISO/TC 176/SC 2, the technical subcommittee that developed ISO 9001:2015, and features useful information on everything from how to get started right through to guidance for those who choose to seek certification. It includes practical advice on the different ways of approaching a quality management system (QMS) as well as detailed guidance on each element of ISO 9001:2015.

Nigel Croft, Chairman of ISO/TC 176/SC 2, said: “This handbook recognizes that small businesses have different needs and challenges compared to large organizations, with different ways of working and often with limited resources. This handbook offers tailored advice to help them implement a quality management system that can truly be useful, and help them to improve their overall business performance.”


For the full story and links to the guideline

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EMA Offers New Guidance on Type II Variations and MA Extensions of Orphan Drugs

The European Medicines Agency (EMA) has updated its post-authorization guidance on how extensions of marketing authorizations and type II variations may impact orphan-designated medicines.

The updates follow the publication of a new notice by the European Commission on the application of Articles 3, 5 and 7 of Regulation (EC) No. 141/2000 on orphan medicinal products. In this notice, the European Commission provides guidance on the application of the Orphan Regulation, more specifically on orphan designation provisions.

EMA says that under the EC guidance, for a new therapeutic indication that falls under a previously confirmed orphan designation, EMA’s Committee for Orphan Medicinal products (COMP) will have to consider whether the specific scope of the variation raises justified and serious doubts in respect to the fulfillment of the orphan-designation criteria. EMA’s updated guidance is to be followed for applications submitted as of the date of publication of the commission’s notice, which was 18 November 2016.

Source: RAPS News & Trends

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Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency (EMA) and to members of the Committee for Medicinal Products for Veterinary use (CVMP)

EMA: Electronic submission via the EMA e-Submission Gateway or Web Client is currently strongly encouraged and will become mandatory as of 1 January 2017.

Source: EMA Veterinary Medicines Division

Read the full dossier requirements at

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FDA Finalizes Guidance on Labeling

The US Food and Drug Administration (FDA) on Friday finalized its guidance for completing the clinical pharmacology section for drug, generic drug and biologic labels.

Specifically, the guidance includes detailed descriptions of the data required for the clinical pharmacology section of the labeling for drugs, biologics and generics for new submissions, as well as amendments to a product’s labeling.

FDA first released the draft version of the guidance in 2009 in order to meet the goals established in its 2006 Physicial Labeling Rule (PLR). However, in 2014, FDA released a revised version of the draft guidance in response to calls for the agency to clarify the information that should be included and how to use headings and subheadings in the section.

Source: Regulatory Affairs Professionals Society

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ICH Advances Three Guidance Documents

The International Council for Harmonisation (ICH) earlier this week announced the advancement of two guidelines to Step 4, or the implementation period of its process, and one question and answer document on the development and manufacture of drug substances to Step 2b of its process, meaning it enters a consultation phase.


ICH E6(R1): Guideline for Good Clinical Practice (GCP) advanced

CH Q3C(R6) Guideline advanced and it revises the permissible daily exposure (PDE) for methyl isobutyl ketone (MIBK), and adds triethylamine (TEA) as a new solvent.

ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

For the full story read it here at

Source: Regulatory Affairs Professionals Society

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European Regulatory Roundup: EMA Releases Draft Guidance on Using Pictograms on Packaging

EMA Posts Draft Guidance on Using Pictograms on Packaging

The European Medicines Agency (EMA) has posted draft guidance on the use of approved pictograms on veterinary medicinal product packaging. EMA has drafted the document to create a harmonized set of pictograms marketing authorization holders (MAHs) can use to communicate effectively in the limited space available on product packaging.

MAHs already have the option to use pictograms — pictorial symbols for words — on the packaging of veterinary medicinal products. However, there has been a lack of guidance on what pictograms to use and how to deploy them effectively. The draft document is intended to address this gap. In doing so, EMA wants to make it easier for MAHs to predict whether it will approve pictogram-enhanced packaging and ensure users understand the meaning of the images.

Source: Regulatory Affairs Professionals Society

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