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PMDA

The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese regulatory agency under the Ministry of Health, Labour and Welfare (MHLW). It is responsible for regulating drugs, medical devices, and other healthcare products in Japan to ensure their safety, efficacy, and quality. The PMDA was established in 2004 to consolidate and strengthen regulatory activities and operates as the national authority overseeing both pre-market evaluation and post-market safety.

Core functions include: pre-market review and approval of new drugs, therapeutics, and medical devices; clinical trial

In addition to domestic regulation, the PMDA participates in international regulatory work, including cooperation with the

oversight
under
good
clinical
practice
(GCP);
GMP
inspections
of
manufacturing
facilities;
post-marketing
safety
surveillance
and
risk
management;
pharmacovigilance
and
adverse
event
reporting;
and
information
dissemination
to
healthcare
providers
and
the
public.
The
PMDA
also
provides
scientific
guidance
to
sponsors
during
product
development
and
collaborates
with
the
Ministry
of
Health,
Labour
and
Welfare
on
regulatory
decisions
and
policy.
International
Council
for
Harmonisation
of
Technical
Requirements
for
Pharmaceuticals
for
Human
Use
(ICH)
and
other
regulatory
authorities.
It
assesses
foreign
clinical
data
as
part
of
Japan’s
regulatory
submissions
and
contributes
to
global
safety
monitoring
and
regulatory
science.
The
agency
operates
with
the
aim
of
ensuring
timely
access
to
safe
and
effective
pharmaceuticals
and
medical
devices
while
maintaining
high
standards
of
quality
and
transparency.