Agência Nacionalde Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA

EXPERT GROUP CONCERNINGPHARMACEUTICAL PRODUCTS MEETING

Kleber Pessoa de MeloKleber Pessoa de Melo Chefe da Unidade de Produtos Controlados

Brasilia-DF(August 25-27, 2003 )

FINAL REPORTFINAL REPORT

BRAZILIAN PRESIDENCYBRAZILIAN PRESIDENCY

Agência Nacionalde Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA

Antigua and Barbuda HaitiArgentina HondurasBahamas JamaicaBarbados México

Belize NicaraguaBolivia PanamáBrasil Paraguay

Canada PerúChile República Dominicana

Colombia San Kittts and NevisCosta Rica Saint LuciaDominica Saint Vincent and the GrenadinesEcuador Suriname

El Salvador Trinidad and TobagoGrenada United States

Guatemala UruguayGuyana Venezuela

Member States Participated Member States Participated

Thirty-nine experts from the following member states participatedThirty-nine experts from the following member states participated

Agência Nacionalde Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA

Working Sessions Working Sessions

• Review and finalize the Guides for Control Systems, Review and finalize the Guides for Control Systems, Industry and Health ProfessionalsIndustry and Health Professionals . .

• Implementation of MEM Hemispheric recommendationsImplementation of MEM Hemispheric recommendations

• Reviewing the items remaining on the plan of actionReviewing the items remaining on the plan of action..

• Presentation by the delegation of Brazil concerning the Presentation by the delegation of Brazil concerning the national pharmaceutical control system that is currently national pharmaceutical control system that is currently being developed and implemented in Brazil.being developed and implemented in Brazil.

Agência Nacionalde Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA

GuidesGuides

• Elements for the Control of Pharmaceutical Products

•Mexico and USA•Reviewed•Finalized

•Guide for Health Professionals•Chile and Venezuela•Reviewed

•Revised Format

•Canada and Uruguay

•Guide for Industry•Colombia and Brazil •Revised Format•Deferred

Agência Nacionalde Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA

MEM RecommendationMEM Recommendation

8. Conduct a thorough review of domestic regulations for the control of Pharmaceuticals and strengthen coordination mechanisms among the relevant sectors.

• The Commission should encourage member states to:• review and update their national legislation and regulations

• The Executive Secretariat should:• establish a section in the CICAD web page concerning the control of

pharmaceutical products  

• link to web pages maintained by member states • national pharmaceutical control legislation and regulations • substances that they control • the name and contact information of a person  

• provide technical legal assistance

Agência Nacionalde Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA

MEM RecommendationMEM Recommendation

10. Implement a hemispheric communication and coordination system in order to improve and facilitate cooperation and coordination among member states on matters related to control of pharmaceutical products and controlled chemical substances at the national and international levels.

Executive Secretariat :•directory of operational points of contact

•directory of official Competent Authorities (INCB)

•CICAD / INCB•plan of action for National Drug Control Database (NDS) implementation

Expert group:• review existing best practices for communication and coordination for discussion during the next expert group meeting

• development of a reference paper

Agência Nacionalde Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA

RecommendationsRecommendations

• Member states

• Executive Secretariat

• Group of Experts

Agência Nacionalde Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA

Executive SecretariatExecutive Secretariat

• Web page• Technical Legal Assistance• CICAD / INCB implementation of NDS• Pilot training seminar

– Implementation of the elements guide– Caribbean

Agência Nacionalde Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA

Group of ExpertsGroup of Experts

1. Group of Experts to meet in 2004

Plan of action:

1. Finalize the Guide for Health Professionals

2. Develop a guide of best practices for communication and coordination

3. Develop a guide of best practices to overcome impediments to effective implementation of regulations and control systems (Chile)

4. Develop a guide of best practices for mechanisms to strengthen inspection, investigation and other control activities

Agência Nacionalde Vigilância Sanitária med.controlados@anvisa.gov.br CICAD/OEA

THANK YOUTHANK YOU