Guidance for

Good Pharmacovigilance Practice

--------------------------------------------------1

-------------------------3

-----------------------------------------------3

---------------------------------------4

-------------------------------------------------5

---------------------------------------6 ------------------------------------------6

-----------------------------------------6

------------------------------------------------7

-----------------------------------------8

--------------------------------------------9 -----------------------------------------9

----------------------------9

---------------------------------------------------9

-----------------------------------11 ------------------------------------------------11

------------------------------------------------11

------------------------------------------------12

--------------------------------------------12

----------------------------------------------------------13

i

: ---------------------------------14

: --------------------------------------15

: ----------------------------------------16

: 0940336107 -----------------------------------17

--------------------------18

: ---------------------------19

PSUR ----------------------20

-----------------------21

0970318606 -------------------------------- 22

ii

12345

45 45-1

()

()

1

()

()

()

()

()

()

()

()

2

[]

[]

3

[]

[]

(periodic safety update report)

4

[]

94 12 2 0940336107 []

97 5 26 0970318606 []

line listings

/

(72 )

5

6

/

--

1.Safety Specification 2.Pharmacovigilance Plan 3. 4.Risk Minimization Plan 5. 6.

7

(signal

detection)

8

9

10

1.

2.

3.

1.

2.

3.

(1)

(2)

4.

11

5.--

6.

7.

12

1. ICH Topic E 2 E Pharmacovigilance Planning (PvP). European Medicines Agency. June 2005 CPMP/ICH/5716/03 2. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. Clinical Medical. March 2005. 3. VOLUME 9A of The Rules Governing Medicinal Products in the European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use Final March 2007. 4. Pharmaceutical Administration and Regulations in Japan. March 2007. http://www.jpma.or.jp/jpmalib/0607/index.html (Japanese) http://www.jpma.or.jp/english/parj/0607.html (English) 5. Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Registered Medicines Regulated by Drug Safety and Evaluation Branch. July 2003 Amended 31 May 2005.

.

13

( 93 08 31 )

1 ()

2

3

4

5

6

7

8

9

14

http://law.moj.gov.tw/Scripts/newsdetail.asp?no=1L0030049http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300491http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300492http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300493http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300494http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300495http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300496http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300497http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300498http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300499

( 93 09 09 )

1

2

()

3

4

5

6

15

http://law.moj.gov.tw/Scripts/newsdetail.asp?no=1L0030050http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300501http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300502http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300503http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300504http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300505http://law.moj.gov.tw/Scripts/Query1B.asp?no=1L00300506

01

1. 2. 3.

4.

(02)2396-0100 (02)2358-4100

___________ 84-664 http://adr.doh.gov.tw

adr@doh.gov.tw

I.

6 5. 8 7 _______ 9

II. 10.

A. B. C. D. E. F. G. H.

12. /

13. /

11.

III.

14. 15.

16.

17 a.

17 b.

18.

20. 21.

19. 22. 23.

IV. / / / 24. #1

#2 25. #1

#2 / 27. 26.

#1 #2

___________

28. 29.

30. * * : _______________ *

16

http://www.adr.doh.gov.tw/mailto:adr@doh.gov.tw

2008.4 0940336107

17

I. 1.

2.

3.

4.

5.

6.

7.

8.

II.

III. 1.

2. ( Line listing )

3.

4. ( Line listing )

5. case report

18

Summary of PSUR for (Period covered: )

_________)

Table ISummary by number of cases

Number Of Cases Type of Cases Taiwan Other countries Serious Non Serious Total (Serious + Non Serious Cases) (+)

19

PSUR Table IITabulation of all Adverse Drug Reactions by SOC in Taiwan (Period covered: ________) SOC ( System Organ Classes)

____________

MedDRA System Organ Class Serious Case Non Serious Cases Total Cumulative Total MedDRA Blood and lymphatic system disorders Cardiac disorders Ear and labyrinth disorders Eye disorders Gastrointestinal disorders General disorders and administration site conditions Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders

Neoplasms benign, malignant and unspecified (including cysts and polyps) Nervous system disorders Pregnancy, puerperium and perinatal conditions Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Vascular disorders Total Cumulative Total

20

Table IIITabulation of all Adverse Drug Reactions by SOC in Others Countries (Period covered: ____) SOC ( System Organ Classes)

____________

MedDRA System Organ Class Serious Case Non Serious Cases Total Cumulative Total MedDRA Blood and lymphatic system disorders Cardiac disorders Ear and labyrinth disorders Eye disorders Gastrointestinal disorders General disorders and administration site conditions Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders

Neoplasms benign, malignant and unspecified (including cysts and polyps) Nervous system disorders Pregnancy, puerperium and perinatal conditions Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Vascular disorders Total Cumulative Total

21

0970318606

22

23