Laura Gomes Castanheira ANVISA- Brazil Implementation of bioequivalent medicines regulation.

Slides:

Advertisements

Similar presentations

Gakava L Roche Products Ltd., Welwyn, UK

Advertisements

ALFREDO LOBO National Institute of Metrology and Quality-Inmetro Director of Quality TBT WORKSHOP ON SUPPLIERS DECLARATION OF CONFORMITY THE BRAZILIAN.

Prequalification of HIV/AIDS Drugs - UN joint activity lPartners* –UNAIDS –UNICEF –UNFPA –WHO –With the support of World Bank lWHO –Manages, provides technical.

First ASEAN-China Conference on Combating Counterfeit Medical Products Jakarta November 2007 CHOO CHEOK HANG DEPARTMENT OF PHARMACEUTICAL SERVICES.

Authors: Rene Soria-Saucedo 1, Veronika J. Wirtz 1, Warren A. Kaplan 2 Institutions: 1 Center for Health Systems Research, National Institute of Public.

Prequalification and Quality Monitoring of anti-malaria products Andre van Zyl, M. Pharm. Project Manager Health Technology and Pharmaceuticals Cluster,

São Paulo 2011 Brazilian Association of Distributors and Importers of Pharmaceuticals Raw Materials.

Biopharmaceutical Regulatory Requirements 1. Marketing Authorization for Chemical Entities MoH Federal Commission for the Protection against Health Risks.

What is a Generic Medication?. The World Health Organization Definition of a Generic Medication A generic drug is a pharmaceutical product, usually intended.

International Experience in Pharmaceutical Services for Promoting Access to Medicines: Canada, Cuba, England, Mexico International Seminar on the Challenges.

Development and Review Process of NDA, ANDA/AADA and OTC Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Associate Professor Department of Pharmaceutics KLE.

Federal Institute for Drugs and Medical Devices The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health 1 Regulatory Requirements.

Regulation of Generic Drugs Office of Generic Drugs Craig Kiester Regulatory Support Branch.

AND GENERIC DRUGS BRAND-NAME AND GENERIC DRUGS WHAT TO CHOOSE? Natalia VEZIKOVA, MD, PhD, Natalia VEZIKOVA, MD, PhD, MSc The Head of the Hospital Therapy.

II Workshop on Medicines Regulation in the Caribbean Region Barbados, September 8 th and 9 th, 2009 Se1 II Workshop on Medicines Regulation in the Caribbean.

Tanzania, August, 2006 Dr. Barbara Sterzik, BfArM, Bonn 1 Guidelines and Tools available TRS 937 and BTIF (Bioequivalence Trial Information Form)

REGISTRATION OF MEDICINES & PROGRESS WITH RESTRUCTURING THE MCC 1.

WHO Prequalification – Medicines Finished Pharmaceutical Products Hua YIN

Documentation of bioequivalence Drs. J. Welink Workshop on WHO prequalification requirements for reproductive health medicines, Jakarta, October 2009.

Bioequivalence Studies Dr Sanet Aspinall, PhD Managing Director AddClin Research Pretoria 20 March 2009.

Federal Institute for Drugs and Medical Devices The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health 1 Quality of Bioequivalence.

What You Want to Know About Generic Drugs Generic Drugs: Safe. Effective. FDA-Approved.

Subsequent Entry Biologics (SEBs) – Canada Presentation to AIPLA Biotechnology Committee January 25, 2012 Daphne C. Lainson

Prequalification project Drs. Jan Welink. * Note to applicants on the choice of comparator products for the prequalification.

1 Supplements and Other Changes to an Approved Application By: Richard J. Stec Jr., Ph.D. February 7, 2007.

Bioequivalence and Bioavailability Working Group.

PRODUCT TRANSFER.

OVERVIEW OF DACA BIOEQUIVALENCE REPORT EVALUATION Presented by Solomon Shiferaw 31Augst 2010.

SFDA-2007 الهيئة العامة للغذاء والدواء Bioequivalence Studies of Generic Pharmaceutical Products Workshop-Day II Introduction and workshop Objectives By:

CONFIDENTIAL ©2014 PAREXEL INTERNATIONAL CORP. ALL RIGHTS RESERVED. THE PRACTICE OF REGULATORY INTELLIGENCE: CASE STUDIES OMICS 5 th International Pharmaceutical.

An Analysis of the Economic/Legal Literature on the Effects of IP Rights as a Barrier to Entry Fordham Center on Law and Information Policy Professor Joel.

ACPS Meeting, October 19-20, 2004 BioINequivalence: Concept and Definition Lawrence X. Yu, Ph. D. Director for Science Office of Generic Drugs, OPS, CDER,

1 TG Dekker – WHO, UkraineOctober 2005 Introduction to Dossier Requirements and Guidelines within the Prequalification Project (quality part) World Health.

WHO Workshop on Assessment of Bioequivalence Data BCS-Biowaivers - Template Dr. Henrike Potthast WHO Workshop on Assessment of.

Topics discussed in the presentation

WHO Prequalification Programme June 2007 Training Workshop on Dissolution, Pharmaceutical Product Interchangeability and Biopharmaceutical Classification.

Bioequivalence Studies and Other Recommendations for Orally Inhaled and Nasal Drug Products: Work of the ITFG/IPAC-RS Collaboration Presented by Cynthia.

Issues in Generic Substitution: Safety/Efficacy, Cost Savings and Supply Robert J. Herman, MD, FRCPC Professor, Department of Medicine University of Calgary.

Assessment of Interchangeable Multisource Medicines BCS-Biowaivers - Template Dr. Henrike Potthast Training workshop: Assessment of.

June 2011Lester Chinery Accessing Quality Assured Supplies (AQAS) An MDAWG Initiative Addis Ababa, June 2011.

WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, October, 2010 Regulatory principles reflected in practice of WHO PQP Milan Smid,

The New Drug Development Process (www. fda. gov/cder/handbook/develop

Generic Industry’s Perspective on the New GMP Initiative May 21, 2003 Generic Pharmaceutical Association Kenneth Lavin, M.Sc. Director, Regulatory Compliance.

WHO Prequalification Programme June 2007 Training Workshop on Dissolution, Pharmaceutical Product Interchangeability and Biopharmaceutical Classification.

Bioequivalence studies: Regulatory Requirements on Conduct & Documentation of BE. Guidance & Experience. Dr Lembit Rägo Coordinator Quality Assurance and.

Dermatopharmacokinetics (DPK)

Introduction What is a Biowaiver?

Malaysia, EVALUTION OF DOSSIERS IN WHO- PREQUALIFICATION PROJECT MULTISOURCE TB-DRUGS Evaluation of bioavailability/bioequivalence data Based,

Deficiencies in Bioequivalence dossiers Overview and Examples.

Milan Smid, MD, PhD Tutorial: WHO Prequalification Programme for Priority Medicines, Beijing, March, 2010 Demonstration of Bioequivalence.

Equivalence pharmaceutical equivalents---drugs must have same active ingredients, in same strength, in same dosage form, same RofA. Inactive ingredients.

Lawrence X. Yu, Ph.D. Director for Science Office of Generic Drugs, OPS, CDER, FDA ACPS Meeting, ACPS Meeting, Oct. 22, 2003 Office of Generic Drugs Research.

Evaluation of quality and interchangeability of medicinal products - WHO Training workshop / 5-9 November |1 | Prequalification programme: Priority.

Federal Institute for Drugs and Medical Devices The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health 1 Statistical Considerations.

Topic #2: Quality by Design and Pharmaceutical Equivalence Ajaz S. Hussain, Ph.D. Office of Pharmaceutical Science Center for Drug Evaluation and Research.

*M.Pharmaceutics (3rd Semester), Anand Pharmacy College, Anand.

Role of VICH and VICH guidelines in the approval process for veterinary medicinal products David Mackay, European Medicines Agency VICH Workshop – Dar.

VICH General Principles and current update of VICH Outreach Forum activity 1.

Regulation of Generic Animal Drugs in the United States

The First Conference for Medicines Regulatory Authorities In Sudan and Neighboring Countries Khartoum December 2014 Alain PRAT, Technical Officer,

NAFTA, CAFTA and Access to Medicines and Food Security in Latin America International Aids Conference Session “Globalization and FTAs: their impact, access.

Business Considerations in eTMF Implementation Karen Roy Phlexglobal Ltd.

Tanzania, August 2006 Dr. Barbara Sterzik, BfArM, Bonn 1 Bioequivalence dossier requirements for the prequalification project WHO Training Workshop.

Introduction What is a Biowaiver?

Industrial Pharmacy.

Analytical Method Validation PAI Readiness / Certification

Prequalification of essential medicines

The WHO Prequalification of Medicines Programme Dossier Assessment

Prequalification of HIV/AIDS products and manufacturers

SID & GP MINPROMTORG OF RUSSIA Corporate Communication Center

Presentation transcript:

Laura Gomes Castanheira ANVISA- Brazil Implementation of bioequivalent medicines regulation

2 Summary -History from Regulations -Challenges -Positive and negative results

3 History - before 1999 Innovator or Similar medicines brand name No generics License granted using similarity approach (same active ingredient and pharmaceutical dosage form of innovator drug) Technical information: production, QC, stability, packaging In vivo studies not necessary

4 History Law 9782 – Creates Anvisa Law 9787 – Creates Generic Drugs in Brazil Resolution 391/99 – ANVISA - first regulation for generic drugs -Pharmaceutical equivalence and bioequivalence for all generics

5 History Resolution 41/00 - criteria for Bioequivalence CROs habilitation and creation of Generic Drugs General Office Bioequivalence Coordination was created, CROs inspections Resolution 133/03 - Pharmaceutical equivalence and bioequivalence study mandatory; Resolution analytical methodology validation; Resolution 897- biowaive; Resolution 134/03 - BE studies for drugs already in the market; risk based approach

Resolution Guideline for bioequivalence studies Electronic information System - SINEB CRO production, electronic submission of BE reports, volunteers national database Normative Instruction 12 - Guideline for controlled released sprays and aerosols Resolution 37 - Biowaive Pharmaceutical form, dosages biowaive, biowaive based on BCS Resolution 27- Bio analytical methodology validation CROs certification system revision History

7 Current Regulations RDC 41/ Habilitation RDC 103/ Certification RE 894/ BE protocol elaboration guideline RE 895/ BE report elaboration guideline RE 898/ Statistical part planning and execution guideline RE 1170/ BE guideline RE 37/ Biowaive RDC 27/ Bioanalytical methodology validation

8 Challenges Reference medicine CROS - national and international Biowaive

9 Positive and negative points Shortage Number of therapeutic equivalents Impact on public purchase Access

10 Thank you!