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 http://www.raps.org/Regulatory-Focus/News
Source: Regulatory Affairs Professionals Society
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In the context of the implementation of the ISO IDMP standards, the European Medicines Agency (EMA) is establishing services to support the management of master data, i.e. substance, product, organisation and referential (collectively referred to as ‘SPOR’) data. The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards. The phased implementation plan envisages the prioritisation of the ‘Referentials’ and the ‘Organisation’ management services (RMS and OMS) in 2016 with the view of making them available in 2017. This document is a preliminary communication on the foreseen transition from the current Article 57 processes to the ‘to be’ SPOR processes. It is aimed at clarifying the change management plan for the provision of information related to the referential and organisation entities, currently managed via the eXtended EudraVigilance Product Report Message (XEVPRM) format, within the OMS and RMS requirements. This document also includes the process change for submissions of approved substance information to the Agency. The requirements will apply to the marketing authorisation holders (MAHs) and sponsors of clinical trials currently submitting data in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD). The processes and technology for the EMA and the relevant stakeholders to enable the registration and maintenance of the master data are currently being established, and will be communicated to all stakeholders once available.
Source: European Medicines Agency
For the full guideline http://www.ema.europa.eu/docs/en_GB/document_library
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New navigation to help users find information more easily
The European Medicines Agency (EMA) has simplified the navigation structure of the regulatory information on human medicines on its website, to help users from pharmaceutical companies find the information they need more quickly and easily.
EMA took action based on detailed feedback from a diverse range of industry stakeholders who use the EMA website for different purposes, and reorganised the navigation accordingly.
The new menu reflects the three main stages of the medicinal product lifecycle, because most industry users said they prefer to look for information on medicines regulation in this way.
Source: European Medicines Agency
Read the full story at http://www.ema.europa.eu/ema
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The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies.
For the full story visit http://www.ema.europa.eu/ema
Contact Samarind for our road-map and solutions for IDMP.
The European Medicines Agency (EMA) has updated its post-authorisation guidance on extensions of marketing authorisations and type II variations to include further details on the information companies need to provide when submitting a type II variation or a marketing authorisation extension for an orphan-designated medicine.
European Medicines Agency
Samarind RMS is capable of allowing you to record and track your variations as well as a whole host of functions to help you get your pharmaceutical product to market. For a demonstration of our product contact us and our team can find a solution to your problem!