Overview of the PAHO strategy and activities to strengthen National Regulatory Authorities in the Americas

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1 Overview of the PAHO strategy and activities to strengthen National Regulatory Authorities in the Americas Ma. de los Angeles Cortes Regional Advisor on Vaccines and Biologicals HSS/MT Annecy, France March 29-31, 2010

2 PAHO strategies to support NRAs Through : 1) PANDRH 2) RNVQCL 3) Regulatory activities in support of the introduction of new vaccines 4) Vaccine Post-Marketing surveillance initiatives (WHO, other global, Regional) 5) PAHO Revolving Fund

3 1) PANDRH: Pan American Network for Drug Regulatory Harmonization 1. Establishes a Pan American Forum of Drug Regulatory Agencies (DRA) to discuss and search for solution of common problems, with DRAs leading and participating in the process. 2. Strengthens the establishment of priorities in drug regulatory harmonization processes and encourage convergence of drug regulatory systems in Region. 3. Improves access to quality, safety & efficacy drugs to improve quality of pharmaceutical markets. 4. Promotes technical cooperation where more developed DRA share knowledge and experiences with less advanced DRA Good Manufacturing Practices Bioequivalence and Bioavailability Good Clinical Practices Drug Classification Counterfeit Drugs Good Laboratory Practices Working Groups Pharmacopoeia Medicinal Plants Drug Registration Pharmacovigilance Vaccines Promotion and Marketing Biotechnological Products (Biosimilars)

4 PANDRH Structure Regulators Andean Area CARICOM MERCOSUR SICA NAFTA INDUSTRY Pan American Conference Steering Committee Secretariat Consumers Academia Professional Associations WG WG WG WG WG WG

5 PANDRH Sub-regional Blocs NAFTA MERCOSUR SICA ANDEAN COMMUNITY CARICOM

6 Technical documents adopted during the last PANDRH Conference (Nov 2008) BE: Framework for Implementation of Equivalence Requirements for Pharmaceutical Products* PV: Good Pharmacovigilance Practices* Vaccines: Harmonized Requirements for the Registration of Vaccines in the Region of the Americas Vaccines: Guidelines for Preparation of a request for registration. GCP: Guide for conducting clinical studies in pediatric populations* GMP: Decision tree for the Implementation of the Guidelines for Good Manufacturing Practices Inspection GMP: Good Manufacturing Practices for Pharmaceutical Ingredients GMP: Code of Ethics for Inspectors of Good Manufacturing Practices

7 2) Regional Network of Vaccines National Quality Control Laboratories (RNVQCL) Objective: To support the National Quality Control Laboratories in the evaluation of vaccines for the Region through: Coordination of activities for the establishment of calibrated Regional Standards against IS, applicable to most used vaccine quality control tests. Harmonization of methodologies and criteria used in vaccine quality control.

8 Regional Standards Are obtained from: Raw material provided by manufacturers or, Standards calibrated against IS donated by Regulatory Agencies (FDA, NIBSC, etc). In the first case, the calibration procedure is established in the Region while in the second the standard is renamed as Regional Standard adopting the original collaborative study.

9 Responsibilities of the RNVQCL members Attending annual meeting Informing about the number of vaccine quality control tests performed per year in their respective laboratories Presenting the quality control chart for each standard as received through the network Sharing any observed deviation in the performance of the standards with other network members

10 The RNVQCL has been working over 10 years to provide reliable standards for the evaluation of vaccines in the Region while supporting the National Laboratories of Quality Control and encouraging the harmonization of tools during the biological evaluation. The development of expertise in the field will contribute to focus the efforts of the laboratories to benefit vaccine recipients. The final goal is to reduce the number of national laboratory performing quality testing, limiting this activity to the most capable in the Region

11 Activities. Examples. International Workshop for the evaluation of potency of Rotavirus vaccine.venezuela, June 2006.

12 Activities: Examples Workshop for the implementation of the Software SP IV for the harmonization of Quality Control Charts for standards and vaccines, June 2008

13 3) PAHO regulatory activities to support the introduction of new vaccines in the Region Coordinating efforts among NRAs that receive submissions of new vaccines Coordinating different components of NRAs dossier evaluation, more specifically: production, quality control, clinical trials and post marketing surveillance. Sharing conclusions of joined reviews that favor weaker NRAs supported by the knowledge of stronger ones. Establishing and coordinating vaccine postmarketing surveillance activities

14 Performed activities in support of the introduction on new vaccines in the Region Meetings involving seven NRAs to review the Rotavirus vaccine dossier prior to WHO prequalification and license in the country of origin Meetings with eight NRAs to review the HPV vaccine dossier, before WHO prequalification and license in the country of origin Conclusions of these meetings assisted Health Authorities in the decision making process to introduce Rotavirus and HPV vaccines in their countries. Training NRAs in the weakest areas, which are the evaluation of clinical trials and vaccine post marketing surveillance. Meeting on regulatory activities for the introduction of pandemic influenza vaccine H1N1, in December The meeting involved 11 countries, with representatives from NRAs and EPI to review: licensing fast track procedures, lot release, and post markeeting surveillance procedures, with experts from WHO, FDA and BGTD

15 Main regulatory constrains in the introduction of new vaccines: No license in the country of origin Efficacy evaluation; establishment of the endpoint for efficacy (different for same product from various manufacturers, rotavirus vaccine) Lack of local epidemiology knowledge in some countries (pneumococcal vaccines) Poor post-marketing surveillance systems in most of the countries

16 Postmarketing surveillance activities in progress Coordinating regional activities for passive postmarketing surveillance activities in some countries (more developed systems). Meeting held in Colombia March 23-24, 2010 Participating in global initiatives: - PAHO/CDC/FDA for active surveillance of risk of intussusception after the introduction of new rotavirus vaccines (Brasil and Mexico) - WHO/FDA global collaboration for surveillance of GBS risk after the introduction of pandemic influenza vaccine H1N1

17 Main constraints in regional vaccine postmarketing surveillance Several initiatives with different objectives (global, regional, for medicines, vaccines, blood product and other biologicals ) Several institutions involved: NRAs, EPI, Epidemilogy, etc. Uneven capabilities in the region (34 countries). Some countries have developed their own data base according their own needs and limitations. All of them receiving great diversity of products SANEVA (regional initiative) network started some years ago, lack financial support. Notification report has been established Diversity of products in the market: new and classic. No baseline information to use as denominator

18 5) PAHO Revolving Fund Project of technical cooperation to support the countries in the procurement of vaccines. Establish a standard of quality in the mechanisms for vaccine acquisition Based in the vaccine quality assurance granted by WHO prequalification (for vaccines included in the PQ system) or the endorsement by regulatory agencies of reference such as FDA, EMEA, BGTD, etc, (for vaccines not included in the PQ systems). It takes in consideration regional needs. Procedure for investigating severe adverse events following immunization with products procured by RF, to generate an opinion on the product, independent of the manufacturer