The Use of eCTD (Electronic Common Technical Document) in New Drug Submissions for Medicinal Products for Human Use

The Electronic Common Technical Document (eCTD) is an interface developed by the International Conference on Harmonisation (ICH) to enable the exchange of regulatory data and information from pharmaceutical industries to regulatory agencies. The content is based on the Common Technical Document (CTD) format and follows an eCTD specification (found on the following site: http://estri.ich.org/eCTD/eCTD_Specification_v3_2_2.pdf -the latest updates/notices relating to the eCTD specifications are available on the FDA website).

The CTD holds information in the form of modules, sections and documents regarding the quality, safety and efficacy of new pharmaceuticals. This format is used in a marketing authorisation application for human use in European Union, Japan and United States (regions that are party to the ICH – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). The CTD defines the content of the common modules (modules 2-5), whereas the contents of the regional module 1 are defined by each of the ICH regions.

EU Regulation of Herbal Medicinal Products

Herbal MedicineProtecting public health whilst maintaining the free movement of herbal medicinal products

Introduction

The 2004/24/EC Directive’s aim is to protect public health while at the same time maintain the free movement of herbal medicinal products within the Community by streamlining the registration process. While most individual herbal medicinal products have continued to be licensed nationally by Member States, the process for licensing has been increasingly harmonised across the European Union.

European Medicines Agency (EMA) – The SME Register

Blog41_photoIncentives for micro, small and medium-sized enterprises (SMEs)

Micro, small and medium-sized enterprises (SMEs) play a vital part in the European Healthcare Industry. They are an excellent source of entrepreneurial skills, innovation and employment. Within the European Union, approximately 23 million SMEs provide 75 million jobs across all industries.

ISO IDMP – TIME IS TICKING

ISO Identification of Medicinal Products (IDMP) legislation

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The ISO Identification of Medicinal Products (IDMP) standard, mandated by the European Medicines Agency (EMA) effective on 1 July 2016, poses a significant compliance challenge for the pharmaceutical industry.  The main aim of IDMP is to define a universal ID for a medicinal product that can be cross-referenced in Individual Case Safety Reports (ICSRs) and support product reconciliation across the entire product supply-chain.

The new EU Clinical Trials Regulation No: 536/2014

Replacing the current Clinical Trials Directive

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On 16 June 2014, the Clinical Trials Regulation (536/2014) entered into force. This Regulation will replace the current Clinical Trials Directive 2001/20/EC which has contributed to a significant drop in the number of clinical trials conducted in the EU.