TRAC's regulatory information hub
The download centre is TRAC's regulatory information hub. You'll find more detailed information on some of the services we offer as well as general news and industry articles written by the TRAC Regulatory Team. We're constantly updating the centre so please feel free to keep visiting to see what's new.
To help you understand the various routes to market that are available and decide which the best option for your product we have produced a document that describes the different types of European Marketing Authorisation Applications.
This download describes the challenges and benefits in the area of paediatric pharmaceuticals including the requirements of the Paediatric Regulation No.1901/2006, Paediatric Investigation Plans, the incentives involved and recent changes in legislation.
With wide experience in guiding pharmaceutical companies through Readability (PIL) testing, TRAC's download provides an essential overview for anyone with responsibility for Readability Testing.
Orphan Drugs - An Overview
In 2000 the European Union (EU) implemented the Orphan Drug Regulation (EC) No 141/2000 to promote the research and development of orphan medicines in the EU. This report provides a brief overview of orphan drugs, an explanation of the application process to obtain orphan designation and information on recent regulation changes.
Medical Devices Regulations
Before a medical device can be sold on the European market it is necessary that the product meets the required standards of safety, quality and performance and therefore can carry the CE mark. This document will guide you through the processes and understand the options that are available for your product.
Obtaining European Regulatory Approval
This document provides an overview of the European regulatory environment and outlines the pharmaceutical regulations and requirements for companies to consider when bringing a new medicinal product to the European market.
eCTD (electronic Common Technical Document) is becoming the compulsory method of submission of regulatory information. This guide has been designed to help you understand the requirements and assess the benefits of this effective method of submission.
UK Clinical Trial Applications
This download reviews the current regulatory procedure for Clinical Trial Applications in the UK. As well as providing an overview of the current process, taking into account recent changes, it also discusses proposed changes for the future.
An Overview of EU Cosmetic Regulations
From 11 July 2013, all manufacturers and distributors of cosmetic products must be compliant with the European Cosmetics Regulation 1223/2009. In this document, TRAC seeks to clarify the key differences between the existing Cosmetic Directive and the new regulation.
EU New Variations - one year on
Graham Donaldson, Senior Regulatory Executive at TRAC, reviews a recent seminar he attended by the MHRA (Medicines and Healthcare products Regulatory Agency) to review the implementation of new variation regulations.
It provides a valuable insight into assessors' experiences highlighting key issues plus some practical guidance going forward.
Embracing eCTD and Lifecycle Management
TRAC's Senior Regulatory Executive, Lisa Pascoe reviews the benefits and challenges of eCTD and lifecycle management one year after the EMA (European Medicines Agency) made this format a mandatory requirement for all submission types.
The Evolving Role of European Regulatory Agencies
In this article Matthew Walker, Senior Regulatory Affairs Executive at TRAC gives an overview of the discussions that took place at the recent joint meeting between The Organisation for Professionals in Regulatory Affairs (TOPRA) and the European Medicines Agency (EMA).
The meeting explored the future role of the Regulatory Agencies and the potential ways they could continue to work with the pharmaceutical industry and patient groups to safeguard public health.
Counterfeit Products and the Safety Profiles of Genuine Medicines
We’ve read numerous articles recently regarding the global rise in counterfeit medicines, the proposed measures to help combat the problem and the cost to the pharmaceutical manufacturers’. However, to date there has been little discussion regarding the impact of these products on safety data.
In this article Sophie Hobson, Pharmacovigilance Manager, attempts to address this and highlights the issues the industry needs to consider.
Reshaping the UK Research & Development Landscape
A look at the recent changes the Big Pharma's are making in their approach to Research & Development (R&D) specifically looking at the impact on the UK pharmaceutical industry. Company director, Jonathan Trethowan wrote this article for Pharmafile's Research & Development Guide published in November 2010.