ICH is coming to Town – European Medicines Agency (EMA)

The International Conference on Harmonization (ICH)  is involved in promoting public health, improve efficiency of new drug development and registration process among other objectives. In order to accomplish this, ICH has developed and implemented harmonized guidelines and standards, also known as ICH6.

ICH Steps

Over 50 guidelines on technical requirements on:
Quality, Safety and Efficacy
Efficacy – 14 topics/17 guidelines
Safety – 8 topics/16 guidelines
Quality – 9 topics/23 guidelines

  • Maintenance of ICH Controlled Terminology Lists
  • Medical dictionary for adverse event reporting and coding
    of clinical trial data (MedDRA)
  • Electronic Standards for the Transfer of Regulatory
    Information
  • Common Technical Document (CTD & eCTD)

The European Medicines Agency (EMA) is a decentralised body of the EU. EMA is responsible for centralised procedure and co-ordination of EU network + plays a role in stimulating innovation and research in the pharmaceutical sector.

EMA is not an FDA for Europe

EMA responsibility does not include:

  • Evaluation of all medicines in the EU
  • Research/development of medicines
  • Clinical trial approval
  • Medical devices
  • EU healthcare policies
EMA Regulatory Process

 

 

Conclusion: ICH-GCP guidelines brought forth public awareness that there was a need to control and regulate clinical trials dealing with drugs and human subjects.

ICH main goal is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

Source:

Guidelines on good clinical practice (European Community and within the ICH regions)  – https://ec.europa.eu/

Presentation – ICH and EU regulatory – www.ema.europa.eu

 

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https://edcdeveloper.wordpress.com/2015/05/11/are-you-practicing-gcp/

https://edcdeveloper.wordpress.com/2011/11/17/21-cfr-part-11-cheat-sheet-for-the-edc-developer/

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