E-DRUG: WHO publication on ICH
------------------------------------------
dear E-druggers,
The WHO organised a meeting on "The Impact of Implementation of ICH
Guidelines in Non-ICH Countries" in Geneva, 13-15 September 2001. The
report was recently published on the www.who.int/medicines website as
number 9 of their Regulatory Support Series:
www.who.int/medicines/library/qsm/who-edm-qsm-2002-3/who-edm-qsm-2002-3.pdf
[Document code: WHO/EDM/QSM/2002.3]
Chapters 5 and 6 of the WHO report discuss the pro's and con's of the ICH
guidelines on non-ICH countries.
For the benefit of E-druggers interested in ICH, here is the exec summary
of the publication:
"Efforts to harmonize various elements of drug regulatory activities have
been
initiated by various intergovernmental organizations at regional and
interregional
level in the past decade. The driving force behind these efforts has been
the increase
in global trade in pharmaceutical products, but also the growth in the
complexity of
technical regulations related to drug efficacy, safety, and quality.
The present report was prepared by a meeting of regulatory officials
convened by the
WHO Secretariat in September 2001. It considers issues arising from recent
developments in activities for the global harmonization of regulatory
requirements
for pharmaceuticals in relation to the activities of the International
Conference on
Harmonization of Technical Requirements for the Registration of
Pharmaceuticals for
Human Use (ICH). The meeting gave special attention to the report on
"International
harmonization of regulatory activities: future options" produced in
1999-2000 by a
WHO review team (see WHO Drug Information, vol. 14(3), pp. 145-159), as
well as
further developments related to ICH activities.
The ICH initiative, which started in 1990, is an interregional venture
covering 17
high-income countries. It includes drug regulatory authorities of the
European Union
(European Agency for the Evaluation of Medicinal Products, EMEA), Japan
(Ministry
of Health, Labour and Welfare, JMHLW), and USA (Food and Drug
Administration,
US FDA), assisted by the research-based pharmaceutical industry
associations of
those countries (the European Federation of Pharmaceutical Industries'
Associations
- EFPIA, the Japan Pharmaceutical Manufacturers Association - JPMA, and the
Pharmaceutical Research and Manufacturers of America - PhRMA). The
International Federation of Pharmaceutical Manufacturers Associations
(IFPMA) acts
as the secretariat of ICH. WHO, Canada (represented by Health Canada) and
the
European Free Trade Area (EFTA) have observer status in ICH activities. ICH
has
produced over 45 guidelines describing technical requirements related to
the process
of drug registration. These guidelines are at present implemented by
regulatory
authorities of the ICH countries.
The ICH guidelines are produced by groups of eminent specialists drawn from
the
regulatory authorities and pharmaceutical companies of the ICH countries.
Their
scientific level is high and they represent an up-to-date approach to
technical
requirements. The costs related to full implementation of the guidelines
are
considerable, but it is argued that they are offset by more rapid
registration of new
drugs in the ICH countries.
The ICH initiative was originally intended to be limited to the evaluation
and
registration of products containing new chemical entities and new products
obtained
by biotechnology introduced on the market of the ICH countries. In the
course of
time the guidelines started to exert an influence in the ICH countries on
requirements
related to existing products, especially in respect of the quality of
generic (multisource)
products and pharmaceutical substances (starting materials). If
implemented,
the extension of ICH requirements in these areas may lead to a considerable
increase
in requirements imposed on local manufacturers in non-ICH countries where
drug
use is based on well established products, linked in many countries to the
manufacture of generic versions of essential drugs. A new situation
concerning ICH
activities arose in March 1999 with the creation, within the ICH Steering
Committee,
of an ICH Global Cooperation Group with, inter alia, the aim of expanding
the use of
ICH recommendations to non-ICH countries. ICH's mounting profile, the
proposed
active dissemination of the guidelines and their adoption by some non-ICH
countries
have led to a growing perception that they represent international
standards.
This new development created a specific challenge for WHO as an
intergovernmental organization with the constitutional task of setting
international
standards related to pharmaceuticals. The difficulties arising from such a
position
were recognized in a resolution of the Ninth International Conference of
Drug
Regulatory Authorities (ICDRA), held in Berlin in April 1999, which
requested that
WHO, when participating in the ICH process, take into account the
implications for
non-ICH countries.
The report of the meeting of regulatory officials considers the
implications of the ICH
process and globalization of its guidelines, describing the benefits of the
ICH process
but also setting out concerns about attempts to extend the influence of
this process to
non-ICH countries. It presents also more specific considerations on
regulatory
requirements in the areas of drug safety, efficacy and quality. Special
emphasis is
placed on the question of global harmonization of regulatory requirements
for
generic drugs. The report also describes the challenges for WHO in respect
of the
international harmonization of drug regulatory activities in the light of
the ICH
process.
The meeting makes the following recommendations:
. WHO should maintain its position as an observer within the ICH Steering
Committee, adopting a more proactive role;
. WHO should maintain its position as an observer in the ICH Global
Cooperation
Group, making clear that its participation is not to be considered as an
automatic
endorsement of ICH guidelines or procedures;
. WHO should establish a consultation procedure for assessing, as early as
possible
in the ICH process, the usefulness of new ICH guidelines for the
pharmaceutical
industry and the drug regulatory authorities in non-ICH countries;
. WHO should establish a mechanism to review and build on ICH guidelines in
order to produce WHO guidelines. It should also assess the benefits and
risks of
implementing selected ICH drug quality guidelines and the possible impact
of
the pharmacopoeia harmonization activities in the ICH regions on standards
for
the manufacture of generic products in non-ICH countries;
. In order to improve access to essential drugs of assured quality,
especially in
developing countries, there is an urgent need for WHO to intensify its
efforts to
further develop international standards and guidelines for the approval of
generic products in consultation with the generic drugs industry, related
organizations and national authorities;
. ICH should be encouraged to benefit from the work already carried out by
WHO
in the area of pharmacovigilance, and all ICH countries should be
encouraged to
participate more actively in the WHO Programme for International Drug
Monitoring:
The meeting requested WHO to bring the above recommendations to the
attention of
both the WHO Expert Committee on Specifications for Pharmaceutical
Preparations
and the Tenth International Conference of Drug Regulatory Authorities
(ICDRA),
Hong Kong, June 2002."
---------
Dr Wilbert Bannenberg, E-drug moderator
Box 456, Irene 0062, South Africa
Mobile +27-82-5756249
Tel +27-12-6671752
Fax +27-12-6671762
Email: WilbertBannenberg@compuserve.com
--
To send a message to E-Drug, write to: e-drug@usa.healthnet.org
To subscribe or unsubscribe, write to: majordomo@usa.healthnet.org
in the body of the message type: subscribe e-drug OR unsubscribe e-drug
To contact a person, send a message to: e-drug-help@usa.healthnet.org
Information and archives: http://www.essentialdrugs.org/edrug