Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation

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Chapter: Pharmacovigilance: Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation

Authorisations for the marketing of medicinal products need to be based on the universal criteria quality, safety and efficacy whilst taking into account local public health needs.


Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation

INTRODUCTION

Authorisations for the marketing of medicinal products need to be based on the universal criteria quality, safety and efficacy whilst taking into account local public health needs. This, together with the prod-uct information instructing the users of medicines on how to use the product effectively and safely, shall ensure a positive benefit–risk balance of the product and its use in individual patients. The development of medicines based on these criteria requires time as well as resources and aims at submitting an appli-cation for marketing authorisation. Such an applica-tion includes all data and is assessed through the process of marketing authorisation evaluation. Part of this process is a continuous dialogue between the applicant and the authorities, as further data emerge from ongoing or follow-up studies initiated by the applicant or requested by the authorities. More and more companies choose to apply for marketing autho-risation in different countries of the world at the same time and in any case products may eventually become available worldwide. Given this background, but moreover from a scientific point of view, it is obvious that standards for how to investigate quality, safety and efficacy should be universal too.

A major step to achieve this was taken in April 1990 when the International Conference on Harmonisation of Technical Requirements for Registration of Pharma-ceuticals for Human Use (ICH, 1997a) was established in Brussels, after preparation at the margins of the 5th International Conference of Drug Regulatory Authori-ties (ICDRA) in Paris in 1989, a conference organised regularly by the World Health Organization (WHO) for their member countries as a forum to strengthen international collaboration between their authorities.

ICH was established with the objective of harmo-nised interpretation and application of technical guidelines and requirements for marketing autho-risation, to

·    reduce duplication of testing,

·    increase economical use of resources and

·    eliminate unnecessary delay in availability of new medicines,

whilst safeguarding quality, safety and efficacy. The five categories agreed for harmonisation are

1.new types of medicinal products,

2.lack of harmonisation of current technical require-ments,

3.transitions to technically improved testing proce-dures,

(all three requiring development of new ICH guide-lines or recommendations)

4.review of existing ICH guidelines resulting in major changes and

5.maintenance of existing ICH guidelines requiring minor changes.

ICH covers the three regions, European Union (EU), Japan and the United States of America, where most pharmaceutical innovations have been developed and consists of the so-called ‘Six Parties’, i.e. the authorities and associations of innovative industry in these three ICH regions:

a. the European Commission, representing the 25 Member States of the EU,1

b.the European Federation of Pharmaceutical Indus-tries and Associations (EFPIA),

c. the Ministry of Health, Labour and Welfare of Japan (MHLW),

d.the Japanese Pharmaceutical Manufacturers Asso-ciation (JPMA),

e. he US Food and Drug Administration (FDA) and

f.  the Pharmaceutical Research and Manufacturers of America (PhRMA).

In addition, there are three ICH observers:

1.the WHO,

2.the European Free Trade Area (EFTA, 1999) repre-sented by the Swiss authority Swissmedic2 and

3.Canada represented by the Canadian authority Health Canada.

These Six Parties develop scientific consensus through discussions between experts from the author-ities and industry. The draft consensus ICH guidelines or recommendations undergo public consultation. Once adopted, the regulatory parties commit themselves to implement the ICH guidelines or recommendations within their local regulatory framework.

The ICH process is administered by the ICH Steer-ing Committee (ICH SC) and supported by the ICH Secretariat that is run by the International Federa-tion of Pharmaceutical Manufacturers Associations (IFPMA) in Geneva. The ICH SC consists of two voting members from each ICH party, one non-voting member from IFPMA and one non-voting observer from each ICH observer party.

The ICH SC also comprises a subcommittee, the ICH Global Cooperation Group (GCG), which is set up from one representative from each ICH party, the ICH Secretariat, WHO, EFTA, Health Canada and from five regional harmonisation initiatives, namely the Asian-Pacific Economic Cooperation (APEC), the Association of Southeast Asian Nations (ASEAN), the Gulf Cooperation Countries (GCC), the Pan-American Network on Drug Regulatory Harmo-nization (PANDRH) and the South African Develop-ment Community (SADC). In May 2005, a revised mission statement was adopted for the GCG, strength-ening their role in promoting mutual understanding of regional harmonisation initiatives to facilitate the regional and global harmonisation related to ICH guidelines and recommendations. Their observership at SC level has been increased accordingly.

So far, ICH has published 53 guidelines in the three areas, quality, safety and efficacy, and provides in addition recommendations in the following multidis-ciplinary areas:

M1: MedDRA – Medical Dictionary for Drug Regulatory Activities,

M2: ESTRI – Electronic Standards for the Transfer of Regulatory Information,

M3: Timing of Pre-Clinical Studies in Relation to Clinical Trials,

M4: CTD – Common Technical Document for marketing authorisation applications and

M5: Data Elements and Standards for Drug Dictio-naries.

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