Record information on drug safety from different resources

Timely detection and mutual exchange of safety data

PSUR India First 2 years : Every 6 months Next 2 years : Annually -

PSUR US First 3 years : Every 3 month Annually

PSUR EU First 2 years : Every 6 months Next 3 years : Annually Every 5 five yrs thereafter

One report for one active substance

All dosage forms and formulations in one PSUR

Fixed combination drugs Cross reference

All clinical and non-clinical safety data ADRs not AE Spontaneous reports : unless specified : ADRs Clinical Study and Literature cases : Not related to drug both by reporter and manufacturer Lack of efficacy : Life threatening condition : Safety issue Increase in frequency of documented ADRs

Date of first marketing authorization for the product granted to any company in any country in the world MAH submit PSUR within 60 days of data lock point

CCDS : Safety, indications, dosing, pharmacology and other information CCSI : Reference safety information
Listed Unlisted Expectedness

Direct reports to MAH

Spontaneous notifications from healthcare professionals Spontaneous notifications from non-health care professionals or consumers MAH sponsored clinical studies

Literature ADR reporting system of Regulatory authorities Epidemiological databases

Internationally accepted ICH coding terminology Controlled vocabulary or Coding dictionary Reporters terms Absence of diagnosis : MAH suggest a diagnosis Disagree with diagnosis Lab abnormality not addressed/evaluated by notifying reporter

Individual case line listings Summary tabulations All serious ADRs All non-serious unlisted ADRs All non-serious listed ADRs

PERIODIC SAFETY UPDATE REPORT FOR: (PRODUCT)

MAHs NAME AND ADDRESS

PERIOD COVERED BY THIS REPORT INTERNATIONAL BIRTH DATE : Date (Country of IBD) DATE OF REPORT

(Other identifying information at the option of MAH, such as Report Number)

Introduction World-wide market authorization status Update of regulatory authority or MAH actions taken for safety reasons Patient exposure Presentation of Individual Case Histories Studies Other Information Overall Safety Evaluation Conclusion Appendix : COMPANY CORE DATA SHEET

This is a periodic safety update report (PSUR) of Paracetomol covering the period.to.. The report summarizes all the adverse reactions reported in connection with the administration of ABC Pharmaceutical's PARAT. ABC Pharmaceutical's PARAT got approval for 500 mg and 650 mg strengths.

PARAT is an antipyretic used for oral administration. Mechanism of paracetomol,etc.

Date of market authorization and subsequent renewal Limits of indications or safety Treatment indications or special populations covered Lack of approval including explanation Withdrawal if related to safety or efficacy Dates of launch Trade name(s)

Country

Submission date/Reg. date

02.07.08
03.08.09

Reg. No
IL-2342MI90
UR7622DED-8

Trade name
ATENO
BETAAT

Comment

Germany
France

Nil
Only for adults & elderly Pediatric usage withdrawn Only for hypertension

UK

05.09.08

PP-521IT78

BENDA

MA withdrawal or suspension Failure to obtain a marketing authorization renewal Restrictions on distribution Clinical trial suspension Dosage modification Changes in target population or indications Formulation changes

Version of CCDS with CCSI Numbered, dated and Revision dates Changes to CCSI
New New New New New contraindications precautions warnings ADRs Interactions

Difficult to arrive how many patients actually exposed Patients treatment years Calculation:

Eg. Drug X 3 g daily for 7 days Vials sold : 21000 of 1g Drug X for a period of 2 years Patient treatment years : Vials sold / total dosage Total dosage : 3 g (3 vials) X 7 = 21 for each patient Hence, 21,000 / 21 = 1000 patients/ 2 years 500 patients/ year

All serious reactions and non-serious unlisted reactions from spontaneous notifications All serious reactions availed from studies All serious and non-serious unlisted reactions from literature All serious reactions from regulatory authorities Non-serious listed : as an addendum to PSUR only when requested by regulatory agencies

MAH case reference number Country Source Age & Sex Daily dosage Date of onset Description of event Patient outcomes : Resolved/Fatal/Improved/Sequelae/Unknow n Comments

MAH Ref. No

Country

Source

Age & Sex

Daily dosag e

Date of onset

Date of treatment

Description of event (MedDRA)

Patient ouctome

commen ts

01299

US

Spont

34, f

500 mg tds

22.03. 07

19.03.07 to 25.03.07

Bleeding gastric ulcer (Gastric ulcer hemorrhage ) Oral thrush (Oral candidiasis)

Resolved

nil

012100

UK

Liter

32,m

UNK

UNK

UNK

Ongoing

Concom ittant steroid may be the cause

An aggregate summary of each of the line listings Separate tables for serious / non-serious Separate tables for listed / unlisted

Brief comments on data concerning individual cases Unanticipated findings ( their nature, medical significance, mechanism, reporting frequency, etc)

All completed studies

Clinical

Non-Clinical

Epidemiological

Studies specifically planned

Studies in progress

Published studies

Studies containing important safety information Study design Study results Clinical and non-clinical study reports

New studies planned to examine a safety issue Objective, Starting date, Projected completion date, Number of subjects, Protocol abstract An Interim analysis Final result

Reports in scientific/medical literature Relevant published abstracts from meetings containing important safety findings Publication reference

Efficacy related information

Product used to treat Serious or life threatening diseases Medically relevant lack of efficacy reporting

Any important new information received after database was frozen for review and report preparation Significant new cases Important follow-up data

Concise analysis of data presented so far Change in characteristics of listed reactions

Severity, outcome, target population

Serious unlisted reactions Non-serious unlisted reactions Increased reporting frequency of listed reactions

Drug interactions Experience with overdosage

Deliberate or accidental

Drug abuse or misuse Positive or negative experience with pregnancy or lactation Experience in special patient groups
Children, elderly, organ impaired

Effects of long term treatment

Should indicate which safety data do not remain in accord with previous cumulative experience and with reference to CCSI Specify and justify any action recommended or initiated