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
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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