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International Conference on Harmonisation and Standardisation Initiatives in the Pharmaceutical Domain

Published online by Cambridge University Press:  20 January 2017

Sabine Brosch  and
Alessandro Spina
Sabine Brosch
Affiliation:
Patient Health Protection Unit, European Medicines Agency
Alessandro Spina
Affiliation:
European Medicines Agency
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Abstract

This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

Type
Reports
Information
European Journal of Risk Regulation , Volume 1 , Issue 3 , September 2010 , pp. 274 - 276
Copyright
Copyright © Cambridge University Press 2010

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References

1 For more information on the ICH, please visit the Internet at <http://www.ich.org>. See also Vogel, D., “The Globalization of Pharmaceutical Regulation”, in 11(1) Governance (2002), pp. 1–22.CrossRefGoogle Scholar

2 This includes the European Free Trade Association (EFTA) – currently represented by Swissmedic (Swiss Agency for Therapeutic Products), Health Canada and the World Health Organization (WHO).

3 This includes the Asia-Pacific Economic Cooperation (APEC), the Association of Southeast Asian Nations (ASEAN), Gulf Cooperation Countries (GCC), the Pan American Network on Drug Regulatory Harmonization (PANDRH) and the Southern African Development Community (SADC).

4 Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections (2009/C 151/01).

5 It should be recalled that the holder of a marketing authorisation for a medicinal product is required to collect, maintain detailed records, report and include in their Periodic Safety Update Records (PSURs) all suspected adverse reactions occurring within or outside the EU territory. See, for example, the obligations set up under Article 24(2) of Regulation (EC) No 726/2004 and Article 104(4) of Directive 2001/83.

6 ISO/DIS 27953-1 Health Informatics – Pharmacovigilance – Individual Case Safety Report – Part 1.

7 ISO/DIS 27953-2 Health Informatics – Pharmacovigilance – Individual Case Safety Report – Part 2: Human pharmaceutical reporting requirements for ICSR.

8 Draft International Standard prEN ISO 11615 Health Informatics – Identification of Medicinal Products – Data elements and structures for the unique identification and exchange of regulated medicinal product information.

9 Ibid.

10 Draft International Standard prEN ISO 11238 Health Informatics – Identification of Medicinal Products – Data elements and structures for the unique identification and exchange of regulated information on substances.

11 Draft International Standard prEN ISO 11239 Health Informatics – Identification of Medicinal Products – Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging.

12 Draft International Standard prEN ISO 11240 Health informatics – Identification of Medicinal Products – Data elements and structures for the unique identification and exchange of units of measurement.

13 Communication from the Commission to the European Parliament and the Council on the Role of European Standardisation in the Framework of European Policies and Legislation COM (2004) 674 fin.