Culture
of Quality
The
Medicines Authority of Malta has established a formal quality management
system (QMS) to define, control, measure and monitor the processes in order
to satisfy regulatory requirements and the needs and expectations of its
customers. Quality is regarded as a key responsibility of all staff and is
viewed as an organization-wide commitment thereby establishing a culture of
quality in all activities and processes undertaken by the Authority.
The
documented QMS covers the activities of the licensing directorate, the
post-licensing directorate, the inspectorate and enforcement directorate,
the operations and regulatory affairs unit and the information technology
unit. The system may be further developed to include other activities as
may be required. Currently a quality manual alongside related SOPs and
guidelines form the bulk of the documentation of the QMS.
In its
commitment to quality the Operations and Regulatory Affairs Unit is
responsible for :-
1.
review of the quality manual and related update of all SOPs across
the Authority
2.
compilation and circulation of general quality procedures
3.
co-ordination of internal audits and submission of auditors’ reports
for management review
4.
handling of customer complaints and eventual submission of reports to
management
5.
other pertinent quality issues as requested by CEO
The
quality system is managed on daily basis by the Operations and Regulatory
Affairs Manager and the documentation officer.
Regulatory Function
New and
updated legislation from the EU is periodically transposed into Maltese
legislation as deemed necessary by the Authority, many times in consultation
with concerned parties. This activity is crucial to the evolving role that
the authority has in ensuring that Maltese law is in harmony with Community
Law. Concurrent with the legal aspect, the Authority is engaged in
reviewing related policies.
Currently
the Authority is undertaking the review of Directive 2004/27/EC which amends
Directive 2001/83/EC. All articles in the new directive have to be
transposed by the end of October 2005 since the new directive comes into
force on 1 November 2005 in all Member States. This new directive will
impose new obligations on national competent authorities, applicants for
marketing authorizations, wholesale dealers and manufacturers. | 
