1. Pharmacovigilance in Korea
QIA
Pharmacovigilance in Korea
Animal, Plant and Fisheries Quarantine agency(QIA)
Presented by Haechul Park

2. Animal, Plant and Fisheries Quarantine Agency
2. The category of Animal Health Products
I. Overview
Animal drugs
Antibiotics, Insecticide,
Analgesics, Antiphlogistic, Biological
Cough Remedy, Expectorant, etc.
Animal
Health Products
Pet cleaners such as Oral Refrigerant, Bath Substances/Detergents/Deodorants, Disinfectants for Animal Sheds Pesticide, Vitamins, Sanitary Goods such as Surgical Drapes, etc.
Quasi-drugs
This slide is about the category of Animal Health Products.
This Diagram shows the three different groups of Animal Health Products which are controlled by us, NVRQS in KOREA.
According to its properties and purpose, Animal Health Products are divided into 3 groups and they are defined like this.
First, Animal drug is a substance which is used to treat or prevent animal disease. This includes Antibiotics, Analgesics and so on.
Next, Quasi-Drug means that it has less pharmaceutical actions than animal drug. For example, disinfectants, Vitamins, Cleaners, etc are included.
Finally, Medical device is an instrument, generally used for treatment, diagnosis and during the therapy. This includes X-ray machines, Blood analyzer and so on.
Medical
Devices
Radioactive Diagnosis Device,
Physical Therapy Instruments,
Blood Analyzer, Surgery Instruments,
Radio-frequency Identification (RFID),
etc.
Animal, Plant and Fisheries Quarantine Agency

3. Relevant Notifications(25)
3. Related Regulations for Animal Health Products
I. Overview
Contents
Application
Acts (2)
Pharmaceutical Affairs Act, The Act on Medical Devices (Ministry of  Health, Welfare and Family Affairs, KFDA)
Enforcement Decree (1)
Enforcement Decree on Facility Standards of Manufacturer, Importers and Distributors of Animal Medicines
(Minister for Food, Agriculture, Forestry and Fisheries)
Enforcement Rule (1)
Handling Rules of Animal Medicines and Others (Minister for Food, Agriculture, Forestry and Fisheries)
Relevant Notifications(25)
2  Including the Tips for Inspecting Animal
Pharmaceutical Affairs (Minister for Food, Agriculture, Forestry and Fisheries)
 - 23 Including the Guideline on Production and Item Permission of Veterinary Drugs (Director General of the NVRQS)
Now, I will give you a brief explanation of the regulations which are related to Animal Health Products management system.
There are 2 most fundamental laws, 2 Acts enacted by KFDA.
These 2 Acts are common regulations for human and animal drugs and a mother law of other regulations, enforcement decree & rule.
And there are 25 relevant Notifications and others too.

4. Ⅱ. Quality Management System of Animal Drugs
2. Responsibilities of Related Organizations
Shaping Animal Drug Policies
Implementation of the Handling Rules of Animal Medicines, etc.
Implement of the Pharmaceutical Affairs Act
Implement of the Act on Medical Devices
MIHWAF
MIFAFF
Municipal government (province, city, Country, ward office)
QIA
For Quality Control of Animal Drugs, 3 organizations and Municipal government share the responsibilities.
First, MIHWF is an abbreviation of [the Ministry of health, welfare and family affair], They enact the mother laws so called ‘Pharmaceutical Affairs Act”
Next, MIFAFF is [the Ministry for food, agriculture, forestry and fisheries], They enact some regulations and make the policies for animal drugs.
And then, QIA, we conduct approval of KVGMP, reassessment, recall, government releasing test and pharmacovigilance.
Finally, the Municipal government controls Animal drug Wholesalers, dealers and clinics.
Regulating
Approval
KVGMP
Reevaluation
Recall
Government releasing test
Phamarcovigilance
Animal Medicine Wholesalers
Pharmaceutical Inspection of Animal Drugs Dealers

5. Regulation flow veterinary drugs from development to post marketing stage
Approval
Distribution
Marketing
Rules for
quality,
safety. etc
Examination for approval
Manufacturing and import
Regulation for labeling,
adversting, etc
Evaluation control
License for
marketing holder
Reevaluation
Assay standard
Reexamination
Clinical test
National assay
Rules for
Authorization
holders
GMP
License of pharmacy
or retailer
Rules for
treatment
GLP
(DMF, BGMP)
(GMP, biologics GMP )
GSP
PMS
GDP
(DUR)
GCP
This is a summarized flow of veterinary drugs regulation system in Korea.
A person intending to market veterinary drugs in Korea shall obtain the license for marketing approval holders . The NVRQS examines an application, on the basis of data submitted by the applicant, and the NVRQS grants the license.
Also, each Veterinary drug is required the marketing approval. The NVRQS issues the license and approval. I explain these details with other slides later.
In addition to approval, Anyone who intends to make drugs for market has to obtain manufacturing license for each factory site. Reevaluation, Reexamination, Adverse reaction report is required.
For these regulations, there are several standards that should be conformed by the approval holder or manufacturer. These standards are described in each ministerial ordinance.
I will talk with details of these systems, mainly GMP, later.
Prescription
system
GVP
(Good Vigilance Practice)
Rules for
regulation
inspection
Restrictin for use
of veterinary
National
assay
Post marketing
surveillance

6. (Including facilities
1. Overview
Ⅱ. Quality Management System of Animal Drugs
Methods
Before Approval
After Approval
Bef. Distribution
Aft. Distribution
Review for approval
Government releasing test
Operation of KVGMP
Self Audit
Random inspection for distributive drugs
Reevaluation for the approved drugs
Reexamination for the new drugs
Recall defective products
(Including facilities
inspection)
(Biologicals only)
The Quality management system is summarized in this slide. This table shows what & how to do for guarantee the quality of animal drugs before and after approval.
In order to assure the quality of the animal drugs, we have various control processes.
The quality management can be mainly divided into 2 process, “before approval” and “after approval”
As a ‘before approval’ process,
Production site, facilities and manufacturing process should be inspected and technical documents should be reviewed as well.
In case of biologics, after approval every batch of biologics is compulsorily required to pass the Government releasing test before distribution in the market.
- For marketing authorized products, we regularly reassess approved drugs, recall defective products and reexamine newly approved products.
- Furthermore, KVGMP operation and Self-Audit is required to guarantee the quality of products in the market.
(Within 6 years)
Animal, Plant and Fisheries Quarantine and Inspection Agency

7. Data required for marketing approval of vet. drugs
Pharmacological
action
Physicochemical property
Protocol of
production
Absorption,
distribution,
metabolism &
excretion
Stability
Veterinary
Drug
Result of
clinical trial
Toxicity
Data required for marketing approval of veterinary drug is shown in this slide.
Among these data required for approval, data of toxicity, target animal safety or residue has to meet the Ministerial ordinance, and data of clinical trial has to meet the Ministerial ordinance
Residue
Safety for the target animal
Approval

8. Subjects on Veterinary Pharmacovigilance
Monitoring & Surveillance Program including
post-market surveillance assay
Manufacturers
(Importers) of
drugs and others
(QIA)
Animal hospitals
[city/regional]
Subjects on
Veterinary
Pharmacovigilance
Manufacturers
(Importers) of
medical devices
(QIA)
Shops/Service
Companies of
medical devices
[city/regional]
Animal
pharmacies
[city/regional]
This slide is about pharmaceutical audit random check on current animal drugs by government
People commissioned by secretary of agriculture minister or mayor are authorized to conduct animal pharmaceutical audit.
NVRQS audits the manufacturers and importers of animal drugs
Province government audits the veterinary hospital, pharmacy and wholesalers
Wholesalers of
animal medicines
[city/mucidal]

9. Pharmaceutical Inspection of animal medicine (post-market surveillance assay)
MIFAFF
(Animal Health Management Division)
Review and approve
inspection plan
Set up and report inspection plan
Set up regular inspection plan,
Pharmaceutical inspection
QIA
(Veterinary Pharmaceutical
Management Division)
Hearing, punishment
Manufacturer, Importer
of animal medicine
provincial government
Notification of
Assay result
Pharmaceutical
inspection
QIA
(Veterinary Drugs and
biologics divisoin)
Request for
assay
Pharmaceutical
inspection and Assay
Wholesalers,
animal pharmacies,
veterinary hospitals

10. Thank you for your attention