JP 130th Anniversary Symposium Varley Dias Sousa 7th .

2y ago
102 Views
2 Downloads
1.41 MB
22 Pages
Last View : 1m ago
Last Download : 2m ago
Upload by : Karl Gosselin
Transcription

ANVISABrazilian PharmacopoeiaJP 130th AnniversarySymposium7th International Meetingof World PharmacopoeiasVarley Dias SousaChair of Brazilian Farmacopoeia CommissionHead of Brazilian Farmacopoeia CoordinationSep. 09 – 15 , 2016Agência Nacionalde Vigilância SanitáriaBRAZILIAN HEALTH REGULATORY AGENCYwww.anvisa.gov.br

DISCLAIMERTHE VIEWS AND OPINIONSPRESENTED HERE REPRESENTTHOSE OF THE SPEAKER ANDSHOULD NOT BE CONSIDERED TOREPRESENT ADVICE OR GUIDANCEON BEHALF OF THE ANVISAAgência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

BRAZIL 26 States Federal District5,570 Cities8,5 mi km² (3,287,357 sq mi)Language: Portuguese206 million people1 – São Paulo: 12 mi2 – Rio de Janeiro: 6,5 mi3 – Brasília: 3 miAgência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

Pharma MarketingDATAPharma market sizePharmacistsPharmacy coursePharmacies and drogstoresCompounding pharmaciesHospital pharmaciesPublic pharmaciesClinical LabsIndustriesRetailersImportersAgência Nacionalde Vigilância 9,7294564,03064www.anvisa.gov.br

ANVISA IN BRAZIL Anvisa’s Headquarter islocated in the capitalBrasília. Nowadays we have around2.000employeesworkingthrough the country, most partare in Brasília.Agência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

BRASÍLIAAgência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

ANVISA’s HEADQUARTERAgência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

Brazilian Pharmacopeial History 1ª edition: Act nº 17.509, Nov. 4, 1926 2ª edition: Act nº 37.843, Sep. 1, 1955 3ª edition: Act nº 78.840, Nov. 25, 1976 4ª edition: Act nº 96.607, Aug. 30, 1988 5ª edition: Resolution nº 49, Nov. 23, 2010 Agência Nacionalde Vigilância Sanitária1ª suplement: Resolution nº 59, Feb.03, 20166ª edition: 1st semester 2017www.anvisa.gov.br

MonographsGeneral tests and assaysAgência Nacionalde Vigilância Sanitária5ª edition5.16ª edition6.1Biological Products301185Blood shed PharmaceuticalProducts (FPP)2106220Herbal Medicines570890Medical 30Medicinal sa.gov.br

CompendiumsBrazilian Pharmacopeia, 5ª edition (2010) (600monographs)Brazilian Homeopathic Pharmacopoeia, 3ª edition(85 monographs)National Formulary, 2ª edition(133 monographs)Memento of Herbal Medicine, 1ª edition (2016)(28 monographs)Agência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

CompendiumsHerbal Medicines National Formulary, 1st edition(83 monographs)List of Brazilian Non proprietary Names (DCB)( 12,000)Quantitative Reference Standards( 100)Homeophatic National Formulary, 1st edition (2016)(100 monographs)Agência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

a Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

Pharmacopeial Recognition1.2.3.4.5.6.7.8.9.10.Japonese PharmacopoeiaGermany PharmacopoeiaUS PharmacopoeiaArgentina PharmacopoeiaBritish PharmacopoeiaEuropean PharmacopoeiaInternational PharmacopoeiaFrench PharmacopoeiaMexican PharmacopoeiaPortuguese PharmacopoeiaAgência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

ANVISA CHARTBOARD OFDIRECTOR SGENERAL OFFICE OFMEDICINESGENERICSNEW DRUGSBIOLOGICPRODUCTSCLINICAL a Nacionalde Vigilância SanitáriaEXPERTSCOMMITEEPOST DICAL DEVICESTABACOBOARD CONTROLFOODCOUNCIL OFTRUSTEESwww.anvisa.gov.br

ORGANIZATION CHARTPHARMACOPOEIACOMMISIONTechnical and scientific coordination(ANVISA)Council ofTrustees 21 members 05 Anvisa 02 Industry 10 Academia 02 Ministries 01 National Quality Lab 01Pharmacy ConcilAgência Nacionalde Vigilância Sanitária18 Experts CommitteesAdministrative coordination(ANVISA)www.anvisa.gov.br

18 Experts QBESPCORBIORADHEM Over a 140 members Academia Industry Government ParityAgência Nacionalde Vigilância Sanitária1.National Policy of Medicinal Plants and Herbal Medicines2.Biological Products3.Medical Devices4.Brazilian Nonproprietary Names5.Pharmaceutical Equivalence and Bioequivalence6.Finish Pharmaceutical Products7.Excipients and adjuvants8.Pharmacognosy9.Medicinal Gases10.Blood Products11.Homeopathy12.Active Pharmaceutical Ingredients13.Compouding and officinal eference Standards17.Textual Standardization18.Herbal Products Tracer (Inative)www.anvisa.gov.br

Monography flowIdentificationof prioritiesExpert CommitteeExecutive Board - AnvisaInvestigationExpert CommitteeOfficial LaboratoriesTecnical EvaluationExpert CommittteeOfficial InquiryTecnical EvaluationCouncil of trusteesBoard of Directors - AnvisaAgência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

Types of Monographies Type 01 – Adoption– A) Patial validation – 01 lab.– B) Full validation – Colaborative Analisys (at least 03)– C) Recognition Type 02 – Adaptation– A) Patial validation – 01 lab.– B) Full validation – Colaborative Analisys (at least 03)– C) Recognition Type 03 – Development– A) Full validation – Colaborative Analisys (at least 03) Type 04 – HarmonizationAgência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

Network laboratories Federal University of Ceará – UFC Federal University of Pernambuco – UFPE Federal University of Minas Gerais – UFMG National Institute of Health Quality Control (INCQS) Federal University of Rio de Janeiro – UFRJ State University of Campinas - UNICAMP Federal University of do Paraná – UPPR Centro Universitário Franciscano – Unifra Federal University of Rio Grande do Sul –UFRGSAgência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

International Convergence USPEuropean Pharmacopoeia - EDQMInternational Pharmacopoeia – WHOPMDA / Japan PharmacopoeiaMercosur ParaguaiVenezuelaAgência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

International Convergence Recognise as Reference Health Regulatory Agency (PAHO)International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)International Generic Drug Regulators Programme (IGDRP)The International Coalition of Medicines RegulatoryAuthorities (ICMRA)International Medical Device Regulators Forum (IMDRF)International Pharmaceutical Regulators Forum (IPRF)World Health Organization (WHO)– Red Panamericana para la Armonización de la Reglamentación Farmacéutica (Red PARF)– International Conference of Drug Regulatory Authorities (ICDRAs)– Framework Convention on Tobacco Control (FCTC)– International Tobacco Regulators’ Conference– International Regulatory Cooperation for Herbal Medicines (IRCH)– Member State mechanism on unterfeit medical products (SSFFC)– Developing Country Vaccine Regulators’ Network (DCVRN)– Codex Alimentarius (FAO)Global Summit on Regulatory Science (GSRS)Commission on Narcotic Drugs (CND) (UN)Technical Barriers to Trade (TBT) (WTO)International Cooperation on Cosmetics Regulation (ICCR)Pesticide Programme (OECD)Pharmaceutical Inspection Co-operation Scheme (PICS)MercosurAgência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

do!Thank you!farmacopeia@anvisa.gov.brAgência Nacionalde Vigilância Sanitáriawww.anvisa.gov.br

Herbal Medicines 57 0 89 0 Medical Products 6 0 1 0 Excipients 0 4 26 10 Radiopharmaceuticals 0 0 3 0 Medicinal Gases 0 0 2 5 . International Pharmacopoeia 8. French Pharmacopoeia 9. Mexican Pharmacopoeia 10. Portuguese Pharmacopoeia. A

Related Documents:

Essays on Modern Japanese Thought. 4,2 Symposium: Japan in the 1970's. 5,2 Symposium: Translation and Japanese Studies. Introduction by Roy Andrew Miller. 6,1 Symposium on Japanese Society. Introduction by Susan B. Hanley. 8,1 Symposium on Ie Society. Introduction by Kozo Yamamura. 11,1 Symposium: Transition From Medieval to Early Modern Japan.

produce this symposium. We hope that this year's symposium will enable all attendees to reach new heights in applying the perspectives and science of human factors/ergonomics to the future of health care. Joseph R. Keebler, PhD Anthony D. (Tony) Andre, Symposium Chair PhD, CPE Symposium Cochair :HOFRPH 1

Celebrate a birthday or an anniversary by dedicating flowers to your loved ones. November 3, 2014 Page 2 Good morning church family, My name is Mike Witt and my wife Mary and I have been members here at St. Stephen for almost a year now. Because Mary and I both have such a passion for mis

Berea St. Paul’s Evangelical 1941 75th anniversary Berea St. Paul’s Evangelical St Paul Lutheran Church Pastor Diaries Berea St. Paul’s Evangelical 2016 150th anniversary history Berea St. Paul’s Evangelical 2016 150th Anniversary sheet Berlin Center Mt. Moriah 2004 175th anniversary/history Bexley Christ 1955 dedication service program

10-YEAR ANNIVERSARY June 19, 2015 w Wilmington . A COPY OF THE OFFICIAL REGISTRATION AND FINANCIAL INFORMATION MAY BE OBTAINED FROM THE FLORIDA DIVISION OF CONSUMER SERVICES BY CALLING TOLL-FREE (800) 435-7352 WITHIN THE STATE OR VIA THE INTERNET . This year marks the 75th anniversary of the hospital and the 10th anniversary of A Night at .

50th Anniversary -KSC 50th Anniversary, program for baccalaureate service, May 22 1955 (2 copies) - -, 50th Anniversary and Dedication program Jun 16 1955 (2 copies) - -, May 20 1955 issue of Antelope (2 copies) - -, KSTC 50th Anniversary Edition of the Kearney Hub, Jun 15 1955, in 3 sections, (2 copies)

50TH ANNIVERSARY WEBSITE Leading up to our official anniversary celebrations, in summer 2016 we launched a 50th anniversary website to provide news, updates and event information as well as a forum for sharing memories of the past and ideas

Andreas M unch and Endre S uli Mathematical Institute, University of Oxford Andrew Wiles Building, Radcli e Observatory Quarter, Woodstock Road Oxford OX2 6GG, UK Barbara Wagner Weierstrass Institute Mohrenstraˇe 39 10117 Berlin, Germany and Technische Universit at Berlin, Institute of Mathematics Straˇe des 17. Juni 136 10623 Berlin, Germany (Communicated by Thomas P. Witelski) Abstract .