E-DRUG: WHA report on quality/safety/regulatory systems
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[The WHO Assembly will discuss this week a report on quality/safety of
medicines (WHA57/15, reproduced below for easy reference).
The report is a bit vague and disappointing. It is surprising to note that
the word pre-qualification does not even feature in this report, even though
it is an important WHO activity. See the prequalification website
(http://mednet3.who.int/prequal/) for better info! Is WHO afraid of the USA
criticism?
Although the Executive Board specifically requested this report to hear the
recommendations of the 16-19 February 2004 ICDRA conference, these are not
given, but only "available on request". E-drug has however found the 24-page
report of ICDRA at
http://www.who.int/medicines/library/qsm/icdra2004/ICDRA11_reportApril2004.p
df where it can be downloaded.
WB]
WORLD HEALTH ORGANIZATION
FIFTY-SEVENTH WORLD HEALTH ASSEMBLY
A57/15
Provisional agenda item 12.12
19 April 2004
Quality and safety of medicines: regulatory systems
Report by the Secretariat
1. At its 113th session in January 2004 the Executive Board reviewed and
noted the report on
quality and safety of medicines, including of blood products.(1) This
present report responds to the
suggestion of members for a progress report in the light of the Eleventh
International Conference of
Drug Regulatory Authorities (Madrid, 16-19 February 2004).
2. Because of the international dimensions of regulation and trade in
medicines and cross-border
public health issues, it is important for regulatory officials of different
nations to cooperate. For more
than 20 years, WHO has provided the secretariat to the International
Conferences of Drug Regulatory
Authorities [ICDRA]. The conferences foster the strengthening of regulatory
systems and offer a unique and
independent forum in which regulators can work towards and reach
international consensus. The
meetings are also instrumental in guiding regulatory authorities, WHO and
interested stakeholders in
issues of national and international regulation of medicines.(2)
3. The role of the regulatory system is to ensure that the manufacture,
trade and use of medicines
are controlled effectively in order to protect and promote public health.
Medicines regulation
encompasses many activities aimed at promoting the availability of safe,
effective high-quality
medicines. The scope and scale of regulatory authorities, always operating
within a legal framework,
vary according to country or region. Their major functions include:
� assessing the safety, efficacy and quality of medicines and approving
products for the market;
� licensing and inspecting manufacturers, retail outlets and pharmacies,
wholesalers, importers
and exporters of medicines;
� calling on independent testing or expertise whenever required to assess
and/or release
products;
� authorizing clinical trials and monitoring their conduct in order to
ensure that clinical data are
of an acceptable standard for use in the regulatory assessment process;
� monitoring and reporting on the safety, efficacy and quality of products
circulating on the
domestic market; and
� providing information on medicines to health-care professionals and the
public.
RECOMMENDATIONS FROM THE CONFERENCES AND REGULATORY CHALLENGES
4. The International Conferences of Drug Regulatory Authorities make
recommendations to both
Member States and WHO on regulatory issues. Over time, these recommendations
have significantly
helped the evolution of regulatory systems in many countries and provided
direction for WHO in this
area. At the Eleventh Conference, which was attended by representatives of
113 regulatory authorities,
participants reviewed achievements since the Tenth Conference (Hong Kong
Special Administrative
Region, China, 24-27 June 2002) and identified regulatory matters that need
urgent action. They
issued major recommendations concerning access to safe medicines,
development of new medicines
and good clinical practices.(3)
5. Accessible and safe, high-quality medicines improve human health and
promote well-being.
The need for high quality has been underlined by the repeated finding in
many countries of
substandard medicines and the devastating consequences of their use.
Vigorous implementation of
good manufacturing practices is a prerequisite for ensuring the high quality
and safety of medicines,
especially at all stages of the preparation of blood products from the blood
donor to the recipient.
6. WHO is undertaking special efforts to raise awareness of the need for
regulatory measures, such
as those covering trade in starting materials, active pharmaceutical
ingredients and excipients, and
assuring the implementation of viral inactivation procedures in the
manufacture of blood products.
Monitoring safety of medicines continues to be important, and new methods of
gathering safety
information on medicines are being explored.
7. Diseases of public health concern sometimes primarily affect poor
populations. Medicines for
these diseases are commercially unattractive because the populations at risk
cannot afford them. As a
result, effective mechanisms are needed to bridge the gap in research and
development. Regulators can
play an important role in supporting initiatives aimed at creating such new
medicines that hold little
commercial incentive. However, there is also a regulatory capacity gap, as
regulators from developing
countries have limited capability to advise on drug development or assess
the safety, efficacy and
quality of new products. Authorities lacking that capability could benefit
from assessment advice
provided by highly developed regulatory authorities, in cooperation with
WHO.
8. Application of good clinical practices ensures that clinical trials and
studies on medicines meet
quality and ethical requirements. Given the increasing numbers of
participants in research, the
regulators� role in good clinical practice should be strengthened. Member
States need to share
knowledge and experience in new areas of clinical research, such as
biotechnology, since data on
safety, efficacy and quality may be limited.
9. Member States can contribute to attaining the goal of improving
regulatory systems through
partnership with WHO in the following actions:
� updating their national regulations to meet international standards and
collaborating in
activities that harness resources and focus on optimal strategies;
� actively seeking ways to increase collaboration and implement the
institutional development
plans of national regulatory authorities with WHO and other regulatory
authorities or regional
networks from both developed and developing countries;
� collaborating in regulatory capacity building by ensuring implementation
of internationally
accepted requirements, norms and standards, and by supporting and
strengthening education
and training in all areas of medicines regulatory activity, and, moreover,
identifying channels
to increase capacity building across boundaries;
� using the principles of the International Conferences of Drug Regulatory
Authorities as a
catalyst for action and framework to strengthen regulatory systems.
ACTION BY THE HEALTH ASSEMBLY
10. The Health Assembly is invited to take note of the report.
= = =
1 Document EB113/10.
2 Within the context of this document, �medicines� is understood to include
medicines, herbal medicines, blood-
derived products, vaccines, biotechnology products and other biologicals
including tissues.
3 The recommendations are available on request.
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