Regulatory
ICH aims to provide uniform standards for technical requirements for pharmaceuticals for human use. They are developed by regulatory and pharma industry authorities. The purpose of ICH guidelines is to ensure safe, effective and high-quality medicines are developed and registered efficiently.
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Registering new products in different countries is a time-consuming and nerve-wracking process. While the information required is essentially the same for various registrations as many countries have adopted the Electronic Common Technical Document (eCTD) standard, the preparation, presentation, and the depth of information submitted vary greatly depending on regional requirements.
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Registering new products in different countries is a time-consuming and nerve-wracking process. For medical device firms, the process is part of an intense period of obtaining a 510(k) clearance or a premarket approval (PMA) in the United States. While the information required is essentially the same for various registrations, the preparation, presentation, and the depth of information submitted vary greatly depending on the country.
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Regulatory professionals in medical device, pharmaceutical and other regulated companies navigate a complex global compliance landscape filled with hurdles. Outmoded paper-based processes that are not connected cause delays and inefficiencies. Worse, departmental silos make collaboration more difficult, thus magnifying any inefficiencies.
Top Tips to Optimize Your eCTD Submission
The FDA mandated the electronic Common Technical Document as the standard format for submissions to ease the burden of pharmaceutical companies and help speed up the submission process. This white paper shares 12 tips for a successful eCTD submission based on a presentation by an FDA official.
This area of quality includes topics like ICH guidelines related to stability studies.
This comprehensive set of ICH guidelines help identify potential risks (e.g., carcinogenicity).
Guidelines in this area relate to the design, conduct, safety and reporting of pharma clinical trials.
These ICH guidances cover topics that don’t fit into the other topics. Examples include the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and others.
ICH guidelines are a set of guidances to ensure safe, effective and high-quality medicines are developed and registered efficiently. These guidelines have been adopted by regulatory authorities throughout the world.
ICH quality guidelines Q1A(R2) through Q1E cover stability, and the related titles are “Stability Testing of New Drug Substances and Products,” “Stability Testing: Photostability Testing of New Drug Substances and Products,” “Stability Testing for New Dosage Forms,” “Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products,” and “Evaluation of Stability Data.”
ICH stands for The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Founded in 1990, it brings together the regulatory and pharma industry authorities. Together they create the ICH guidelines.
The Common Technical Document (CTD) is maintained by ICH. In the CTD, quality, safety and efficacy information are put together in a common format. The CTD enabled the implementation of good review practices. It makes the regulatory review process simple. With the CTD, reformatting information for different ICH regulatory authorities is a thing of the past.CTD has five modules. The first is region specific and the remaining four are meant to apply to all regions.
The U.S. Food and Drug Administration (FDA) is a founding member of ICH. Per the agency's website, they promote ICH requirements and their use by by pharma regulatory authorities around the globe. As a member, FDA can, among other things, endorse draft ICH guidelines.
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