Regulation for Aquaculture Medicine Dr. Sasi Jaroenpioj Department of Livestock Medicine THAILAND 8 July 2015.

Slides:

Advertisements

Similar presentations

© 2004 by Thomson Delmar Learning, a part of the Thomson Corporation. Fundamentals of Pharmacology for Veterinary Technicians Chapter 2 Veterinary Drug.

Advertisements

LEGISLATION, REGISTRATION AND CONTROL PROCEDURES FOR VETERINARY MEDICINAL PRODUCTS IN SOUTH AFRICA Dr R D Sykes DAKAR Senegal 2008.

Office of New Animal Drug Evaluation Laura L. Hungerford, DVM, MPH, PhD Senior Advisor, Science and Policy, ONADE Professor, University of Maryland School.

1 David Loschke18 March 2005 New Zealand Timber Preservation Council Annual Conference 2005 The Australian Pesticides & Veterinary Medicines Authority.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH Working with FDA: Biological Products and Clinical Development Critical Path.

What Do Toxicologists Do?

Pharmaceutical Development and Review Process Rev. 10/21/2014 APGO Interaction with Industry: A Medical Student Guide.

Jennifer Matysczak, VMD Leader, Aquaculture Drugs Team US Food and Drug Administration Center for Veterinary Medicine Office of New Animal Drug Evaluation.

Stefan Franzén Introduction to clinical trials.

+ Drug Development and Review Process. + Objectives Learn the processes involved in drug discovery and development Define the phases involved in FDA drug.

Cancer Nanotechnology: New Opportunities for Targeted Therapies FDA Public Meeting October 10, 2006 Piotr Grodzinski, Ph.D. Director, Nanotechnology for.

Career Opportunities for PharmDs in the Pharmaceutical Industry: Research & Development.

Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / October |1 | Regulatory Requirement on Dossier of Medicinal.

1 FDA Thailand By HIV Module/Marketing Group Mr. Manaswee Arayasiri.

Mrs. Brandi Robinson Office of New Animal Drug Evaluation Center for Veterinary Medicine Regulating Animal Drugs.

REGISTRATION OF MEDICINES & PROGRESS WITH RESTRUCTURING THE MCC 1.

Guidance for Industry M4S: The CTD-Safety

Registration in lebanon

Eureka Pre-Clinical Investigation Animal toxicology Animal pharmacokinetics/ pharmacodynamics Clinical Investigation Phase I Safety and pharmacology Phase.

CVM’s Procedure for Setting Tolerances

Prof. Moustafa M. Mohamed Vice dean Faculty of Allied Medical Science Pharos University in Alexandria Development and Regulation of Medical Products (MEDR-101)

Jasper Ogwal-Okeng Gulu University Research Workshop 3 rd -6 th March 08.

1 Regulation of drug research. 2 What is drug research? There are two approaches: a wider and a pragmatic one The latter make a difference between „research.

Biotech Inventions in Latin America Argentina Ignacio Sánchez Echagüe Marval, O’Farrell & Mairal.

Stefan Franzén Introduction to clinical trials.

REGULATORY CHALLENGES FOR NANOMATERIALS IN PUBLIC HEALTH Driving Faster Than Our Nano-Headlights AAAS Annual Meeting February 13, 2009 Norris E. Alderson,

DRUG DEVELOPMENT & REGULATIONS DR ARIF HASHMI. DRUG DEVELOPMENT Discovery and synthesis Preclinical development (chemical testing, biological testing,

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

INTRODUCTION TO TOXICOLOGY SIDNEY GREEN, PH.D. DEPARTMENT OF PHARMACOLOGY COLLEGE OF MEDICINE HOWARD UNIVERISTY.

CHEE DRUG PRODUCT DEVELOPMENT u Drug ä agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in man or animals.

Investigational Drugs in the hospital. + What is Investigational Drug? Investigational or experimental drugs are new drugs that have not yet been approved.

Important informations

TECHNICAL REQUIREMENTS FOR MINOR APPLICATIONS E MOKANTLA 3 SEPTEMBER 2013.

Prof. Dr. Wolfgang Dekant Department of Toxicology University of Würzburg Germany Risk, Hazard, and Innovation.

1/33.  What is INDA ?  Types of INDAs  Objectives of INDAs  Format & Contents of an INDA  IND Safety reports  IND Annual Reports  IND Review Process.

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

Chapter 2 Veterinary Drug Development and Control

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September |1 | Prequalification programme:

Overview of Drugs and Biologics Dr Léo Bouthillier, Therapeutic Products Directorate & Dr Omar Tounekti, Biologics and Genetic Therapies Directorate Health.

European Patients’ Academy on Therapeutic Innovation Non-clinical development.

European Patients’ Academy on Therapeutic Innovation The key principles of pharmacology.

Office of Clinical Pharmacology and Biopharmaceutics IDSA/ISAP/FDA Workshop 4/16/04 Current Status of Dose Selection in Antimicrobial Drug Development.

An agency of the European Union Presented by: Kornelia Grein Role of VICH and VICH guidelines in marketing authorizations 2 nd VICH Outreach Forum meeting,

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

1 VICH AND VETERINARY MEDICINES AVAILABILITY VICH5 CONFERENCE, OCTOBER 2015, TOKYO VICH AND VETERINARY MEDICINES AVAILABILITY VICH5 CONFERENCE, OCTOBER.

An agency of the European Union Principles for the assessment and authorisation of antimicrobials in the EU VICH Outreach Forum, October 2015 Presented.

Introduce GLP/GCP into China Shixin XU, PhD, Prof. China IVDC.

Regulatory Approval Process for Veterinary Drugs – A Global Perspective M. R. Srinivasan and P. Sriram Laboratory Animal Medicine, Centre for Animal Health.

Veterinary Products Management and Quality Control System in Thailand : Veterinary Vaccine Tasanee Lorchaivej Workshop on the Veterinary Products.

Link between legal framework of VMP regulation and VICH GLs in Japan Takashi Kozasa DVM Ministry of Agriculture, Forestry and Fisheries Government of Japan.

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

The process of drug development. Drug development 0,8 – 1 mld. USD.

The Regulation on Cell Therapy Products in Japan

Waiving TABST for vaccines Argentina: Not an allowed procedure today Require batch safety tests in laboratory animals, repeated by authorities Currently.

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

1 1 Topics “out of the scope of VICH” Brigitte Boenisch IFAH-Europe 2 nd VICH Outreach Forum Meeting Washington, 19 th /20 th February 2012 – how and by.

Implementation of The Russian Pharmacovigilance regulation Alexander Panin State Veterinary and Phytosanitary Surveillance Agency of the Russian Federation.

Pharmacology Science that studies interactions of drugs with organism on different levels (subcellular, cellular, organ, systemic) Studies: - relationship.

for Human Pharmaceuticals Kyung-Chul Choi D.V.M., Ph.D.

Regulatory– Terms & Definitions רגולציה - מונחים והגדרות

Prof. Dr. Basavaraj K. Nanjwade

The Lifecycle of Pharmaceutical products

Biopharmaceutics Dr Mohammad Issa Saleh.

The 3Rs principles for safety testing of human and veterinary medicines A view on the EU regulatory developments in 3Rs (replacement, reduction, refinement)

GL18 (R) – Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substance and Excipients.

Quality guidelines on impurities

Control of Veterinary Drugs in South Africa

Storage and distribution

NIGERIAN REGISTRATION SYSTEMS OF VETERINARY MEDICINAL PRODUCTS :

Presentation transcript:

Regulation for Aquaculture Medicine Dr. Sasi Jaroenpioj Department of Livestock Medicine THAILAND 8 July 2015

Regulations under Drug Act Pre-marketing Control Licensing Registration Adversetisment Control Post-marketing Control Licensee’,Pharmacists’ and Drug store surveillance as mentioned in the Act GMP Audit Drug Surveillance ADR Monitoring Drug Reevaluation

List of licensed antimicrobials for use in aquatic animal in Thailand Amoxycillin Enrofloxcin Sarafloxacin Oxolinic acid Oxytetracycline Sulfadimethoxine sodium / Ormethoprim Sulfadimethoxine sodium / Trimethoprim Sulfadiazine and Trimethoprim Sulfadimidine and Trimetroprim Sulfamonomethoxine Sodium Toltrazuril 10/1/2016

List of banned antimicrobials in aquatic animal in Thailand Chloramphenical Nitrofuran and their Metabolites (Furazolidone, Furaltadone,Nitrofurazone and Nitrofurantoin) Malachite green and Leuco-malachite green 10/1/2016

5 Classification of Veterinary Drugs Generic VMPs (Existing drugs) - For food producing animals - For companion animals New VMPs - For food producing animals - For companion animals

6 VMPs Registration Procedure

7 VMPs REGISTRATION PROCEDURE Part II Drug quality and analytical method - Quality control -Manufacturing process -Stability data Part I Safety and efficacy - Packaging Component - Certificate of Free Sales - Safety&Efficacy dossier - Samples Experts Apply for registration certificate

8 GENERAL DRUG REGISTRATION PROCESS Revision Reject Document Approval Registration Granted - Add. Document- Reference Experts

9 Document required for New VMPs for food producing spp.submission

10 The same as Generic drugs Route of synthesis for NCE Chemical / Pharmaceutical Documents Document required for New Veterinary Drug for food producing spp. Submission (1)

11 Pharmacological Documents Pharmacokinetics Pharmacodynamics Document required for New Veterinary Drug for food producing spp. Submission (2)

12 Risk Assessment Ø hazard identification Ø dose response assessment Ø exposure assessment Ø risk characterization Systemic toxicity l Hepatotoxicity (Pk+Pd) l Renal toxicity (Pk+Pd) l Reproductive toxicity (Pk+Pd) l Teratogenic toxicity (Pk+Pd) l Neurotoxicity (Pk+Pd) Human food safety Target animal safety NOAEL(NOEL) ADI Toxicological Documents Document required for New Veterinary Drug for food producing spp. Submission (3)

13 - Human Safety - Target Animal Safety - Environmental Safety - User Safety - The analytical method to determine the drug in edible tissue Safety Document required for New Veterinary Drug for food producing spp. Submission (4)

14 · Effectiveness - a study in a target species - a study in laboratory animal - any field investigation and in vitro study Clinical Documents Document required for New Veterinary Drug for food producing spp. Submission (5)

Thank you