International%20Conference%20of%20Drug%20Regulatory%20Authorities%20(ICDRA)

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International Conference of Drug Regulatory
Authorities (ICDRA)
Dr Lembit Rägo and Dr Sabine Kopp Quality
Assurance and Safety Medicines Medicines, Policy
and Standards World Health Organization
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Examples ofregulatory harmonization efforts and
fora

• Association of South-East Asian Nations (ASEAN)
• Andean Community (CAN)
• Collaboration Agreement of Drug Regulatory
  Authorities in European Union Associated
  Countries (CADREAC) most (10) countries
  involved entered EU in 2004
• European Union (EU)
• Gulf Cooperation Council (GCC)
• International Conference on Harmonisation (ICH)
• International Conference of Drug Regulatory
  Authorities (ICDRA)
• MERCOSUR (Southern Common Market)
• Pan American Network on Drug Regulatory
  Harmonization (PANDRH)
• Southern African Development Community (SADC)
• .

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WHO MEDICINES STRATEGY 2004-2007

• Goal
• Our vision is that
• people everywhere have access to
• the essential medicines they need
• that the medicines are safe, effective,
• and of good quality and that medicines
• are prescribed and used rationally

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WHO Medicines Strategy Four Objectives

• POLICY Commitment among all stakeholders to
  medicines policies based on the essential
  medicines concept, and to coordinated
  implementation, monitoring and evaluation of
  policies
• ACCESS Equitable financing, affordability and
  delivery of essential medicines in line with the
  Millennium Development Goals
• QUALITY AND SAFETY The quality, safety and
  efficacy of all medicines assured by
  strengthening and putting into practice
  regulatory and quality assurance standards
• RATIONAL USE Therapeutically sound and
  cost-effective use of medicines by health
  professionals and consumers

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WHO Medicines Strategy Seven Components

• POLICY
• 1. Implementation and monitoring of medicines
  policies
• 2. Traditional medicine and complementary and
  alternative medicines
• ACCESS
• 3. Fair financing mechanisms and affordability of
  essential medicines
• 4. Medicines supply systems
• QUALITY AND SAFETY
• 5. Norms and standards for pharmaceuticals
• 6. Medicines regulation and quality assurance
  systems
• RATIONAL USE
• 7. Rational use by health care professionals and
  consumers

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Information exchange activities

• Biennial ICDRA conference
• WHO Drug Information (quarterly)
• WHO Pharmaceutical Newsletter (bimonthly)
• Rapid Alerts (upon need)
• WHO International Drug Monitoring Program
• Annual National Pharmacovigilance Centres
  meetings

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ICDRA Who? Why? What?

• Unique forum for drug regulatory authorities of
  all WHO Member States
• To strengthen collaboration
• Instrumental in guiding regulatory authorities,
  WHO and interested stakeholders
• Determine priorities for action in national and
  international regulation of medicines, vaccines,
  biomedicines and herbals

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Objectives of the International Conference of
Drug Regulatory Authorities (ICDRA)

• To promote collaboration between drug regulatory
  authorities
• To reach a consensus on matters of interest
• To facilitate timely and adequate exchange of
  information
• To discuss issues of international relevance

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Recent challenges for Drug Regulatory Authorities

• Globalisation and extension of free trade
• Sophistication of products
• New technologies and health care techniques
• Internet (sale and information)
• Counterfeit drugs
• .

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1996 2004 meetings ? http//www.who.int/medici
nes/icdra.shtml

• 8th International Conference of Drug Regulatory
  Authorities (ICDRA)
• Bahrain, 10-13 November 1996
• 9th International Conference of Drug Regulatory
  Authorities (ICDRA)
• Berlin, 25-29 April 1999
• 10th International Conference of Drug Regulatory
  Authorities (ICDRA)
• Hong Kong, China, 24-27 June 2002 
•  11th International Conference of Drug Regulatory
  Authorities (ICDRA)
• Madrid, Spain, 16-19 February 2004

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ICDRA Participants, some figures

• 9th ICDRA (Berlin)
• more than 280 participants from 90 Member States
• 10th ICDRA (Hongkong)
• from 100 Member States
• 11th ICDRA (Madrid)
• from 110 Member States, and regional regulatory
  authorities and pharmacopoeias

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Eleventh International Conference of Drug
Regulatory Authorities (ICDRA) 16 - 19 February
2004 Madrid, Spain
Progress Report on Tenth ICDRA Dr Vladimir K.
Lepakhin Assistant Director-General Health
Technology and Pharmaceuticals World Health
Organization, Geneva
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Access to drugs and vaccines

• In collaboration with Member States, focus on
  good trade and distribution practices of starting
  materials to ensure use of high quality materials

• The WHO Expert Committee on Specifications for
  Pharmaceutical Preparations adopted
• (1) Good Trade and Distribution Practices (GTDP)
  and
• (2) WHO Pharmaceutical Starting Materials
  Certification Scheme (SMACS)
• Both received approval from the WHO Executive
  Board in January 2004

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Safety of Blood Derived Products

• A GMP programme applied to blood and plasma
  collection centres will be initiated in June
  2004. First workshop will be held in Argentina,
  in collaboration with the Region for the Americas
  

• Promote the regulation of blood and plasma
  collection centres, ensuring GMP compliance -
  regional cooperation - training

• Training activities are targeted at national
  regulatory authorities and blood transfusion
  services

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Regulating Biotechnology Products

• Monitor developments and continue to provide
  clear guidelines on issues related to the
  quality, safety and efficacy of
  biotechnology-derived medicinal products,
  including biocomparability

• Consultations convened since the ICDRA
• (a) WHO Monitoring Group on gene transfer
  medicinal products (May 2003) and
• (b) Characterization and Quality Aspects of
  Vaccines based on Live Viral Vectors (December
  2003)

• Continue to develop international biological
  reference materials that can serve as reference
  standards for new products

• WHO has established 29 new or replacement
  international biological reference materials in
  the past two years

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Regulatory challenges Health Sector Reform and
Drug Regulatory Capacity

• Study existing experience and undertake research
  in order to develop models for intensified
  collaboration and, where appropriate, joint
  decision-making among national regulatory
  authorities

• The EMEA model for joint decision-making is being
  tested in regional and subregional networks of
  regulatory authorities

• Further support national authorities to introduce
  or improve data management systems in order to
  produce and interchange information and to
  achieve evidence-based decision-making.

• Model information management system developed in
  collaboration with EMEA being promoted as a model
  for other countries to use as reference in all
  WHO regions

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Counterfeit drugs

• Strengthen the existing anti-counterfeit liaison
  officers to promote exchange of information on
  counterfeit drugs amongst and between regulatory
  authorities and WHO

• WHOs web site counterfeit pages have been
  updated, made user-friendly and the content
  revised and updated

• Tools for CFT reporting have been revised and can
  now be downloaded

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E-commerce

• Establish and maintain a list of national focal
  points and circulate it to all regulatory
  authorities in order to foster international
  collaboration in combating illegal pharmaceutical
  e-commerce

• List of national focal points created.
  International collaboration encouraged through ad
  hoc messages at international symposia

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Sessions in 11th ICDRA (1)

• Pharmacopoeias in a changing regulatory
  environment
• Regulatory assessment of combination products
• Regulators, GCP and Ethics
• Public health needs vs the marketplace
• Regulatory aspects of access to medicines
• Safety of herbal medicines
• Assuring quality and safety of blood products

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Sessions in 11th ICDRA (2)

• Strengthening of regulatory frameworks for
  medicinal products
• Human tissue problems and challenges for
  regulators
• Regulatory tools for providing drug information
• Harmonization updates
• Promoting good regulatory practices
• Recommendations in
• WHO Drug Information Vol 18, No. 1, 2004
• Full report of 11th ICDRA with all presentations
  on CD available and on web

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Pharmacopoeias in a changing regulatory
environment (recommendations)

• Member States to encourage close collaboration
  between regulatory authorities and pharmacopoeial
  secretariats/commissions
• WHO should organize an international conference
  on pharmacopoeial issues in collaboration with
  parties concerned
• WHO to develop a harmonized approach to
  providing internationally validated
  specifications for medicines for neglected and
  emerging diseases of high public health risk
• Seven ARVs' adopted in 2004 for inclusion in
  Int.Ph. (didanosine, - indinavir sulfate, -
  nelfinavir mesilate, - nevirapine,
• - ritonavir, - saquinavir, - saquinavir
  mesilate)

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Pharmacopoeias in a changing regulatory
environment (recommendations continued-)

• WHO to continue to support the establishment
• of international chemical reference substances
  (ICRS)
• ? ICRS newly available for antimalarials agents
  artemisinin
  derivatives
• ? ICRS for antiretrovirals underway

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Regulatory assessment of combination products
(recommendations)

• Regulators to critically review the existing
  fixed dose combination drugs on the market and
  withdraw those
• which do not meet these requirements
• WHO is urged to create as a matter of
• urgency model guidelines for regulatory
• approval of prescription-only fixed dose
  combination
• drugs with emphasis on drugs for communicable
  diseases with high public health impact
• ? Newly adopted WHO guideline on FDCs (39th WHO
  Expert Committee, Annex 5, in preparation)

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Regulators, Good Clinical Practice and Ethics
(recommendations)

• Member States to implement GCP in all clinical
  research and to ensure that informed consent
  processes meet all GCP, national and ethical
  requirements.
• WHO Handbook on GCP implementation drafted (to be
  finalized in 2005)
• Guidance material on how to ensure the quality of
  BE studies carried out by CROs drafted (to be
  finalized in 2005)
• Member States to recognize that gene therapy is a
  new complex area of medicine needing rigorously
  implemented GCP and ethical oversight

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Regulators, Good Clinical Practice and Ethics
(recommendations)

• WHO to gather and to share with Member States
  existing knowledge and experience of safety,
  efficacy and quality of innovative biotechnology
  products
• WHO to accelerate its work in regulatory capacity
  building for assessment of vaccines and medicines
  of public health importance
• A number of specified workshops for regulators
  organized by WHO in 2004 and 2005

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Some more 11th ICDRA recommendations

• Regulators have role and responsibility to
  facilitate access to drugs of public health
  importance to facilitate access without
  compromising on quality, safety and efficacy.
• ? guidelines on registration requirements to
  establish interchangeability of multisource
  (generic) pharmaceutical products (revision in
  progress), discussion on biowaivers and
  international comparators list
• ? good distribution practices (GDP) for
  pharmaceutical products (in progress)
• -gt harmonization efforts regarding stability
  testing

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Some more 11th ICDRA recommendations

• Member States to strengthen efforts to increase
  transparency of drug regulatory authorities.
• WHO to continue pre-qualification of drugs for
  priority disease programmes, particularly HIV,
  malaria and TB.
• Transparency of prequalification increased with
  WHO Public Assessment (WHOPARs) and Inspection
  Reports (WHOPIRs) going to web good example to
  follow for MS?

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• 12th ICDRA

When? Spring 2006 Where? Seoul,
Republic of Korea Program? Planning
meeting in Geneva April 2005 Suggestions
for topics to be discussed welcome Dr Lembit
Rägo (ragol_at_who.int)
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Thank you! !Muchas gracias!

http//www.who.int/medicines/