introduction to pharmacovigilance , principles, function and procedures, reporting of ADRs for centrally authorized products

1. Conduct of
Pharmacovigilance
For Centrally
Authorized products
Submitted To: Dr. Vikash Budhwar
Submitted by: Bindu Kshtriya

2. Pharmacovigilance
○ Pharmacovigilance(PV) is the pharmacological
science relating to the detection, assessment,
understanding and prevention of adverse effects,
particularly long term and short term side effect of
medicines.
○ All medicines(pharmaceutical and vaccines) have
side effects. Some are known and many are still
unknown even the medicine has been in clinical use.
It is important to monitor both known and unknown
side effects of medicines in order to determine any
new information in relation to their safety profile.

3. AIM & OBJECTIVE
AIM
○ To identify new information about hazards as associated
with medicines.
OBJECTIVES:-
○ To improve patient care and safety.
○ To improve public health and safety.
○ To encourage safe, rational and appropriate use of drugs.
○ To promote understanding, education and clinical training in
pharmacovigilance.

4. Introduction
The conduct of Pharmacovigilance for centrally
authorized products rests on obligations and
activities placed through legislation on a no. of
parties , i.e Member States, European
Commission, EMEA, MAHs.
In order to ensure the obligations are met , it is
necessary to clarify the respective responsibilities
and roles of various parties.

5. Legal frame work
Legal provision for centrally authorized products : Title 2 of Council
Regulation(EEC) no. 2309/93 of 22 July 1993 and Council Regulation (EC) no
540/95of 10 March 1995.
Obligation of MAH:
Article 22: MAH are obliged to report within 15 days all suspected serious
adverse drug reaction occurring within the EU.
MAH have to report all suspected serious unexpected ADRs from outside the EU
to the EMEA and MS within 15 days.
MAH have to submit PSURs to EMEA & MS, at least every six months during
the first2 years following authorization and once a year the following 3 years.

6. Obligation of Member State:
Article 23: MS have to report all suspected
serious ADRs occurring within their territory to
EMEa within 15 days.

7. Obligation of EMEA:
Article 20: Agency should receive all relevant
information about suspected ADRs for Centrally
Authorized Products.
Article 23: EMEA must inform national
pharmacovigilance systems of suspected serious
ADRs occurring with in MS.

8. Working Plan
Adverse drug reaction on suspicion
Adverse drug reaction on reporting
Adverse drug reaction on analysis
Sharing of findings

9. Work Plan
1.Pre- authorization:
Rapporteur should take the lead in
pharmacovigilance acting to evaluate all issues
relevant to centrally authorized product (CAP).
2. Post-authorization:
Rapporteur will have the responsibility for
evaluating and reaching conclusions.
Information related to risk & benefits of CAP need
to be continuously collected in all member states.

10. Continued…
Scientific expertise of MS will be utilized by
rapporteur in carrying out pharmacovigilance
evaluations.
EMEA Secretariat should collect all the
information about ADRs & distribute this
information to MS.
EMEA Secretariat in close co-operation with the
rapporteur , will inform the CPMP/Phv working
party of any drug hazard concerned.

11. PhVWP provides a forum for discussion &
evaluation of emerging data in order to reach
recommendations for consideration by CPMP.
A Drug Monitor for CAP will be created to track
safety issues and will be reviewed at each
meeting of PhVWP.
Primary Responsibility of MAH is to assure the
safety of their product.
Therefore, MAH is obliged to adhere to legs
provisions as to the spontaneous reporting of
ADRs as well as to submission of PSURs and
other information.

12. Monitoring & Control of
Authorization
1. Signal Generation:
Many potential signals will emerge in early stage of marketing
and it will be important for these to be effectively evaluated.
A signal of possible unexpected hazards may be identified by:
•MAH
•Rapporteur
•Member State
• EMEA

13. 2. RISK EVALUATION
As signals of possible unexpected hazards may emerge from many
different sources of data, the relevant information needs to be brought
together for effective evaluation, over a time scale appropriate to the
importance.
Risk Evaluation should be carried out by:
•Rapporteur
•Member State where a signal originated
The rapporteur should work closely with originator of alert to evaluate the
issues.

14. 3.Periodic safety update reports
(PSURs)
MAH is required to provide PSURs to all MS & EMEA at 6
months intervals post marketing for the first 2 years
annually for the subsequent 3 years and 5 yearly
thereafter.
MAH should submit any consequential variations
simultaneously with PSURs st the time of submission , in
order to prevent any unnecessary duplication of effort.
Rapporteur will evaluate and provide a report in
accordance with the agreed timetable and to determine
what issues if any need to be referred to the PhVWP &
CPMP

15. 4. Post Authorization
Studies
Final & interim reports of MAH sponsored post
authorization studies and any other studies, and other
relevant information, may emerge from MAH, MS, or other
countries at times in between periodic safety reports.
Rapporteur should receive and assess any relevant
information and provide an assessment report.
when changes to marketing authorization are required,
CPMP will adopt an opinion which will be forwarded to
commission for decision.

16. 5. Post Authorization
Comments
EMEA Secretariat should ensure that MAH meets the
deadlines for the fulfillment of specific obligations and
follow up measures, and that the information provided is
available to the rapporteur and to the CPMP.
MAH should submit a consequential variations
simultaneously with the requested information for the
fulfillment of specific/ follow up measures, in order to
prevent any unnecessary duplication of efforts.

17. For marketing authorization granted under
exceptional circumstances, specific obligations will be
set up in annex 2 C of the CPMP opinion.
For marketing authorization granted under
exceptional circumstances, the annual review will
include a reassessment of risk/benefit profile.
The annual review will in all cases lead to the
adoption of an opinion which will be forwarded to the
commission for preparation of decision.

18. THANK YOU