Transcript THE NATIONAL ADVERSE DRUG REACTION (ADR) REPORTING …

PHARMACOVIGILANCE &
THE NATIONAL ADVERSE
DRUG REACTION (ADR)
REPORTING SYSTEM
Sarah Spiteri
Post-Licensing Directorate
Medicines Authority
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Legal Framework for
Pharmacovigilance (PhV)
“The Authority shall set up a pharmacovigilance
system which shall be used to collect information
which is useful in the surveillance of medicinal
products, with particular reference to adverse
reactions in human beings, to evaluate scientifically
such information and to take into account any
available information on the misuse and the abuse of
medicinal products which may have an impact on the
evaluation of their benefits and risks.”
(Article 4(a) of L.N. 22 of 2004)
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Legal Framework for PhV
“The Authority shall ensure that reports of
suspected serious adverse reactions that have
taken place on its territory are immediately
made available to the marketing authorisation
holder, the Commission, the Agency and
Member States within 15 calendar days of
their notification.”
(Article 7 of L.N. 22 of 2004)
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Legal Framework for PhV
“The Authority shall suspend, withdraw or vary a
marketing authorisation whenever such action results
necessary following an evaluation of pharmacovigilance
data. Such decision shall be communicated to the
Agency, to the Member States and to the marketing
authorisation holder.
In any case of urgency, the Authority may suspend the
marketing authorisation of a medicinal product,
provided that the Agency, the Commission and the
Member States are informed thereof at the latest on the
following working day.”
(Article 8 of L.N. 22 of 2004)
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Role of the Medicines
Authority
Collection
of information on ADRs from
Healthcare Professionals (HCPs) and the
pharmaceutical industry;
Scientific evaluation of the information collected;
Expedited reporting of suspected serious ADRs to
relevant Marketing Authorisation Holders (MAHs);
Regulatory action if so required following
evaluation of data;
Communication of the outcome of data evaluation.
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Role of the Medicines
Authority
Sharing
information with HCPs and pharmaceutical
companies;
Sharing of information with regulatory authorities
in other Member States;
Operation within a wider international framework,
including the EU and the WHO International Drug
Monitoring Programme;
Provision of Guidance Notes for Stakeholders.
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Development of the PhV
System
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Development of an ADR reporting form
ADR database
Consistent with EU legislation and guidance
Developed with advice of experts from other MS
(Ireland)
Regular attendance at Pharmacovigilance Working
Party (PhVWP)
Associate Members in WHO (leading to eventual
Full Membership)
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Evaluation of Safety Data
and Regulatory Action
Scientific evaluation of:
Individual reports
Cumulative information
- Literature Reports
- Study Reports
- Global Safety Data
Regulatory
action
Dear HCP letters
Regular “Drug Safety Bulletin”
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Collaboration with
Stakeholders
Co-operation among all partners in sharing safety
information is essential for the Medicines Authority
to carry out its functions wrt:
Collation and evaluation of new safety information;
Detection and prevention of potential safety
hazards;
Provision of an information service to HCPs and
MAHs
Safeguarding public health.
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Thank you for your attention
You can visit our website at:
http://www.health.gov.mt/mru
Email: [email protected]
Tel. No.: +356-23439135
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