Biological Product Work Group GT BIO 6 th Pan-American Conference for the Harmonization of Pharmaceutical Regulations (CPARF) Brasilia, 06 – 08 July 2011

Full Members: MERCOSUR: Patricia Aprea, Argentina (Alternate Coordinator) ANDEAN COMMUNITY: Hans Vásquez, Peru SICA: Gioconda Castillero, Panama CARICOM: Junia Walcott, Trinidad and Tobago NAFTA: Elwyn Griffiths, Canada FIFARMA: José Manuel Cousiño, Chile ALIFAR: Néstor Annibali, Argentina OTHERS: Olga L. Jacobo, Cuba / María T. Ibarz, Venezuela Alternate Members: MERCOSUR: Marcelo Moreira, Brazil (Coordinator) ANDEAN COMMUNITY: Patricia Carmona, Chile SICA: Ana Beatriz Cordero, Guatemala CARICOM: Maryam Hinds, Barbados ALIFAR: Valentina Carricarte, Argentina Secretary (OPS/OMS): María Luz Pombo Current Members of the GT BIO

January 2010 Meeting of the Management Committee of the PAR Network Creation of the GT BIO agreed June st meeting of the GT The mission, objectives, and work plan developed December 2010 Information exchange system Translation into Spanish and Portuguese of the document “WHO Guidelines on evaluation of similar biotherapeutic products (SBPs)” Background

Objectives ActivitiesDate Responsible Objective 1: Compile all of the regulations on biotechnological products available in the countries and facilitate their access at the Regional level 1.1. Compile the regulations on biotechnological products for each participating ARN in the GT BIO and the recommendations of the MOS, including those related to similar biological products if available GT BIO Secretariat 1.2. Compile the regulations for biotechnological products of other ARN’s, including those related to similar biological products if available GT BIO Secretariat 1.3. Disseminate the information compiled Regionally, through the mechanism established for such (Web OPS or other) 2011 Secretariat

Objectives ActivitiesDate Responsible Objective 2: Establish a glossary of terms that facilitates the future development of related documents 2.1. Identify the terms related to biotechnological products (from the regulations compiled in Objective 1) which will be included in the glossary of terms 2010 Coordinator GT BIO 2.2. Produce a document that contains the terms related to the regulation of biotechnological products based on: Definitions established in the regulations compiled in Objective Glossary of Medications: Development, Evaluation, and Use (OPS/OMS) 001/ ;jsessionid=3dv5qfulfl6lu.alice 001/ ;jsessionid=3dv5qfulfl6lu.alice 2011GT BIO 2.3. Disseminate and consult on the draft of the glossary of terms produced by the GT BIO 2011 Secretariat 2.4. Generate a final Regional glossary of terms on biotechnological products, to be submitted to the Managing Committee of the PAR Network 2011GT BIO

Objectives ActivitiesDate Responsible Objective 3: Promote the exchange of information among National Regulatory Authorities in the Americas Region 3.1. Generate a proposal to foster the exchange of information related to the regulation of biotechnological products among the ARN’s of the Region To be defined GT BIO 3.2. Create a system to exchange information on the regulation of biotechnology products To be defined Secretariat

Objectives ActivitiesDate Responsible Objective 4: Identify documents and guidelines for short- and long-term preparation 4.2. Translate into Spanish and Portuguese the document “WHO Guidelines on evaluation of similar biotherapeutic products (SBPs)” (6) and obtain the copyrights for the subsequent publication thereof 2010 Coordinator Secretariat 4.3. Technical review of the translation into Spanish and Portuguese of the document “WHO Guidelines on evaluation of similar biotherapeutic products (SBPs)” (6) 2011 GT BIO (Spanish- and Portuguese- speaking countries) 4.4. Publish the Spanish and Portuguese version of the document “WHO Guidelines on evaluation of similar biotherapeutic products (SBPs)” (6) for contribution to the work on the PAR Network 2011Secretariat

Objectives ActivitiesDate Responsible Objective 5: Identify other items related to the regulation of biotechnological products that require specific treatment and establish the corresponding work plans to handle those items 5.2. Propose information that should be on the PAR Network’s Website on the GT BIO 2010 GT BIO / Secretariat Objective 6: Develop tools and training activities aimed at strengthening the National Regulatory Authorities of the Region in matters related to the regulation of these products, when so requested 6.2. Disseminate related reference material Continuo us GT BIO / Secretariat

Implementation of more efficient communications mechanisms for members of the GT Bio (SharePoint, Illuminate virtual meeting room for the group). Production of Technical Document No. 7 of the PAR Network: Translation of the recommendations of the MOS for bio similar products in Portuguese and Spanish, in order to: “facilitate the disclosure of the content thereof in Spanish- and Portuguese-speaking countries in the America Region; so that those recommendations might be adopted in whole or in part, or be used as bases to establish regulatory frameworks for the authorization to sell (health registry) similar biotechnological products. Compilation of definitions and requirements to register biological and biotechnological products in the Americas subregions. Results “WHO Guidelines on evaluation of similar biotherapeutic products Biotechnical Products Work Group PAR Technical Document No. 7 Pan American Pharmaceutical Regulation Harmonization Network

Work Plan Speed up the work of the group to meet the proposed objectives. 2.Promote training activities related to biotechnological products. 3.Continue identifying documents and regional guidelines for the preparation thereof in the short- to medium-term. 4.Identify challenges and opportunities for the implementation of Technical Document No. 7 of the PAR Network, by the ARN’s.

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