Philippine National Health Research

System (PNHRS): Clinical Trials in the

Philippine Health Research Registry

Ms. Merlita M. Opena

Philippine Council for Health Research and Development

Department of Science and Technology

1

Research for Health

Science, Technology & Innovation Tools

3

DESCRIPTION

Integrated national framework for health research in

the country

A convergence strategy that aims to promote

cooperation and integration of all health research

efforts and stakeholders in the country to ensure

that research contributes to evidence-informed

health policies and actions

4

VISION

A vibrant, dynamic

and responsible

health research

community working

for the attainment of

national and global

health goals

The PNHRS Environment

SOCIETY

HEALTH SECTOR

RESEARCH

AGENDA ETHICS UTILIZATION

RESOURCE

MOBILIZATION

CAPACITY

BUILDING

RESEARCH (PNHRS)

AREAS OF PNHRS

CONNECTING HEALTH RESEARCH TO THE HEALTH SECTOR & PHILIPPINE SOCIETY

GOVERNANC

E

RESEARC

H AGENDA NUHRA

CAPACITY

BUILDING

ETHICS

UTILIZATI

ON

RESOURCE

MOBILIZATIO

N

CRITICAL MASS

OF

RESEARCHERS

REGISTERED

ACCREDITED IRB /

ERCs

POLICIES,

IMPROVED

PROCESSES,

PRODUCTS &

SERVICES

ATTAIN

TARGETS OF 5

AREAS

FUND

UTILIZATION

HEALT

H OF

THE

SYSTE

M

AREAS OF PNHRS KRA’s / INDICATORS

REPORT

REPORT

REPORT

REPORT

REPORT

GOVERNAN

CE

CONTRIBUTIO

N TO

BENCHMARK

(2% THE)

REPORT

Republic of the Philippines

Congress of the Philippines Metro Manila

Fifteenth Congress

Third Regular Session

Begun and held in Metro Manila, on Monday, the twenty-third day of July, two

thousand twelve..

----------------------

Be it enacted by the Senate and House of Representatives of the Philippines in Congress

assembled:

[Republic Act No. 10532]

AN ACT INSTITUTIONALIZING THE

PHILIPPINE NATIONAL HEALTH RESEARCH

SYSTEM

RA 10532 Implementing Rules & Regulations

Rule 28. All health researches shall be

registered in the Philippine Health Research

Registry, and when published, to the national

repository (HERDIN) of published health

researches. The Secretariat shall develop

and disseminate guidelines to enable

institutions to share their research

information to these registries and databases

www.herdin.ph (working with WPRIM)

Philippine Health Research Registry

Registry for ongoing and newly approved projects; populated by project teams

Launched in August 2012 with the help of WHO; elements comply with WHO

Developed in response to request from Food & Drug Administration (FDA) re clinical trials

FDA taps the Philippine Health Research Ethics Board which accredited 6 Ethics Review Committes to work with FDA

FDA Circular 2012-007

Mandates all clinical trials

approved from July 15, 2012-

onwards be registered within

30 days after the application

to conduct the clinical trial

has been granted

Registered Researches (clinical and

non-clinical trials) as of July ‘13

Clinical trials

Non-clinical trials

Maraming salamat

Nalulugod kaming maging

bahagi ng pulong na ito