The
Therapeutic Goods Administration (TGA) is set to strengthen its
collaboration with the European Directorate for the Quality of Medicines
and HealthCare (EDQM).
In
May 2014 Australia was accepted as an assessor in the EDQM's procedure
for the Certification of Suitability to the monographs of the European
Pharmacopoeia (CEPs). The certification procedure for CEPs assesses the
suitability of monographs to control the chemical purity,
microbiological quality and transmissible spongiform encephalopathy
(TSE) risk (if relevant) for any substance covered by a European
Pharmacopoeia monograph.
TGA
assessors will take part in the scientific assessment of applications
submitted by manufacturers to obtain a CEP. This will allow Australia to
share information, skills and experience with our international
colleagues leading to more informed and consistent regulatory decisions
internationally.
Australia
is one of a handful of countries outside of European member states that
recognises CEPs in its evaluation processes for generic medicines.
Working together with regulators from different jurisdictions to develop
common standards, guidelines and regulatory requirements will reduce
the time to market for therapeutic products ensuring Australians have
access to quality medicines in a timely manner
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