Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
EDITOR-IN-CHIEF
contents
3
A YEAR IN REVIEW
Top HPRG Stories in 2014!
HOT OFF-THE-PRESS
CRP-CRCS Forum
As
st P
Group rof Raym
o
Direc
tor, H nd Chua
PRG,
HSA
s,
Dear Reader
the Health
year for us in
sy and fruitful
pe it has been
bu
a
ho
I
en
d
an
be
)
s
G
It ha
Group (HPR
n
tio
la
int, I will
gu
po
is
Re
Products
siness. At th
rthcoming
u and your bu
fo
d
yo
r
an
fo
ng
ise
gi
likew
ing so enga
be
r
fo
t to improve
u
pu
yo
in
k
d
like to than
s, opinion an
ew
vi
ur
1 year.
yo
us
over the past
in sharing with
and policies
d to
em
st
sy
ry
to
n look forwar
the regula
e Goat, we ca
of th
llaborate with
r in the year
gage and co
rse and ushe
e
planned to en
ell to the Ho
w
ve
er enhance th
re
ha
rth
fa
e
fu
d
w
bi
to
at
e
th
ns
s
tio
As w
hcare institu
ng speed at
citing initiative
ni
alt
ex
ht
he
of
lig
d
e
ar
an
th
ye
ry
r
of
are
anothe
in the indust
ts. We are aw
sophisticated
stakeholders
increasingly
health produc
our different
inging with it
br
of the various
. Besides,
g,
es
in
ies
ch
nc
ap
oa
va
er
pr
th
e ad
regulatory ap
tissue-based
d
technology ar
l
an
ll
ica
e
ce
or
ed
m
as
m
e
d
an
such
o expect to se
ent options,
which science
ity, we will als
are, such
d new treatm
tiv
hc
an
ec
alt
es
nn
he
vic
co
g
ive
de
l
ct
st-effe
medica
and increasin
onitoring
r and more co
g population
ial for tele-m
nts for bette
with an agein
eted at patie
ith the potent
w
rg
ts and the
ta
es
uc
es
vic
od
vic
de
pr
innovative de
and telehealth
derstand such
ns
un
r
tio
tte
ica
ties, so too
be
pl
ni
ap
to
rtu
po
ed
alth
immense op
as mobile he
therefore a ne
g
in
is
e
br
er
ts
Th
en
n.
will need to
lopm
ultatio
such, HPRG
ese new deve
and tele-cons
fore risks. As
em. While th
be
th
the scientific
d
nd
re
of
hi
te
g
be
in
un
nd
co
ta
en
technology
better unders
w and never
ne
re
su
vative
of
en
no
ies
in
to
ilit
d
ib
ders
w an
are the poss
rent stakehol
ss of these ne
umers, whilst
gage the diffe
itate the acce
ns
en
cil
co
lly
fa
d
d
ua
an
in
an
s
s
nt
co
patient
odalitie
needs of our
ts, business m
the medical
developmen
ore to meet
ap
ng
Si
to
in
products
r of the
public health.
g the transfe
safeguarding
back regardin
ed
fe
Products
h
ek
alt
se
He
to
the
tion
der consulta
isting laws to
ol
ex
e
eh
ies, such
th
ak
lic
r
st
r
de
po
un
and
inue ou
tical products
ory controls
We will cont
the Change
e our regulat
of pharmaceu
as
fin
ls
re
ro
ell
w
er
nt
co
as
rth
,
y
fu
tions
regulator
a move to
drug applica
re that
n, there will be
submission of
vices. To ensu
Act. In additio
rency in the
r medical de
fo
pa
e on
ns
ns
ey
tra
tio
d
an
Ac
an
ep
s
ctive
RG will also ke
as the timeline
Safety Corre
. And thats
ess and Field
up-to-date, HP
ism
oc
pt
rg
pr
ke
ne
n
e
sy
tio
ar
d
ica
ies
ent an
Notif
and polic
experts each
ensure alignm
y framework
lopments to
gulators and
e
our regulator
r overseas re
gulatory deve
ou
re
to enhance th
al
ith
o
w
ob
als
s
gl
d
ar
d
an
min
regional an
stakeholders
sions
rums and se
fo
us
ry
st
sc
lar
di
du
gu
p
in
re
r
ou
t
ou
uc
s of
cus gr
why we cond
e of these fo
ory awarenes
rward to mor
se the regulat
u can look fo
year, to increa
Yo
s.
or
lat
gu
of our re
competency
ernising
s in 2015!
2015 as Mod
and initiative
is first issue in
th
licies to
of
po
e
d
em
an
th
k
e
or
aptly titled th
latory framew
ve
gu
ha
re
coming
r
e
w
ts
ou
d,
uc
in
of
od
ro
pr
e in m
we future-p
erging health
as
With all thes
em
de
d
out all
ca
an
ith
De
w
w
,
the ne
elves
the Next
e to take on
journey ours
Regulation in
are willing
rking on this
and adaptabl
e
e
ba
w
bl
,
m
em
tly
ni
be
ien
be
ot
effic
allow us to
. And we cann
fectively and
hanisms
term horizon
d to do so ef
athering mec
up in the near
d feedback-g
llaborators! An
an
co
ent.
t
d
m
en
an
on
m
s
er
vir
ge
enga
ing en
r partn
proaches of
e fast-chang
of you as ou
innovative ap
cope with th
d
nt
an
re
ffe
nd
di
ou
t
gr
to try ou
rstand the
ered to be
n better unde
r 8 is consid
so that we ca
d the numbe
an
behalf of
gy
on
lo
y,
rit
tro
as
pe
e
pros
th sign in Chines
fortune and
,
8
r New
e
om
na
th
isd
is
Lu
w
at
hy
g
lisin
e Go
rous and healt
And since th
mber, symbo
happy, prospe
a
auspicious nu
s
d
er
an
ad
y
re
ck
r
lu
a very
e to wish ou
A, I would lik
HPRG and HS
!
at
Year of the Go
ely,
Yours Sincer
Raymond
SPECIAL FEATURE
8
10
12
INTERNATIONAL
ENGAGEMENT
Bringing Together International
Experts 2014 APEC Harmonisation
Centre-Health Sciences Authority
Cell- and Tissue-Based Therapeutic
Products Workshop
13
REGULATORY UPDATES
Dialogue Sessions with Our Industry
Stakeholders 2014
Faster Correction of Existing Medical
Devices in the Market Following Field
Safety Corrective Actions
Improving Timelines and
Transparency of Drug Applications
HSA Facilitates Competency Building
in Medical Device Regulatory Affairs
16
FUN LEARNING
Navigate the New Revamped
HPRG Website
editorial team
Editor-in-Chief
Asst Prof Raymond Chua
Executive Editor
Angie Tan
Assistant Editors
Choong Chih Tzer, Diana Koh,
Valerie Wee
Contributing Authors
Ananda Padmanabhan Muthalagu,
Choong Chih Tzer, Dr Lakshmidevi
Balakrishnan, Dr Srinivasan Kellathur,
Evelyn Lee, Kenneth Low, Mae Mah,
Natalie Low, Neo Cherng Yeu,
Patricia Ng, Sia Chong Hock,
Sumitra Sachidanandan, Valerie Wee,
Wong Woei Jiuang
Corporate Content
Contributors
Sophus Chong, Wang Yunshi
Advisors
Lee Hui Keng, Suwarin Chaturapit
NEX2US
VIEW
A YEAR IN RE
TOP HPRG
!
4
1
0
2
N
I
S
E
STORI
Nove
mber
20
14
Collab
orate
d
Healt
with M
ha
inistry
(HPB) nd Health
of
Pr
to car
ry out omotion B
sessio
oard
ns wit
engag
h
e
on Po
int-of tobacco re ment
-Sale
t
a
tobac
ilers
Dis
co pro
ducts play ban o
f
14
September 20
N Panel
Led the 1st ASEA
ss the
se
as
to
of Experts
valency
ui
eq
r
fo
A
FD
Thai
mework
to the PIC/S fra
in the
n
sio
clu
in
r
fo
and
ASEAN
ed
pt
ce
List of Ac
s
ice
rv
Se
n
tio
ec
Insp
Novem
ber 2014
mber 2014
January Dece
forts by
ic education ef
Enhanced publ
As consumer
HS
e
ut
rib
st
di
to
partnering HPB
g illegal
yin
bu
of
e dangers
booklets on th
s messages
A
and to carry HS
health products
reening &
Sc
l
na
tio
nc
unity Fu
at HPBs Comm
ents respectively
Lose To Win ev
Signed
the ASE
AN
Medical
Device
Directiv
e Agree
ment
on conv
ergence
of regu
latory
controls
for med
ical
devices
with
ASEAN
regulato
ry
authori
ties
l 201
the
ation
nced
Enha e Notific
g
Chan s for
l
es
dica
proc ered Me
t
s
Regi s
ce
Devi
Apri
vember 2014
October No
March
Nov
ember
7th In
2014
ternati
onal G
7th A
eneric
CSS C
Drug R
onsorti
egulato
12th
u
m Gen
rs Pilo
Stand
erics W
t Meeti
ing Co
Sympo
orking
ng
mmitte
sium o
Group
e Mee
f the W
Meetin
Harmo
ting an
g
estern
nisatio
d 5th
P
n of H
2014
erbal M acific Regio Internationa
APEC
l
n
e
al For
dicine
Harmo
um fo
Cell- a
s
nisatio
r the
nd Tis
n
C
s
ue-ba
Firstsed Th entreHealt
in-wor
h
erapeu
ld pilo
tic Pro Sciences Au
Regio
t
tr
ducts
thority
nal Cli
a
in
in
g
Works
nical T
progra
hop,
rials
mme o
n Mult
i-
Augus
t No
White
tion
Rabbit
r 20
Opera
tion
Cactu
s
60,634
enhan units of sex
ce
u
worth ment prod al
ucts
$151,58
5
30,49
1u
enhan nits of sexu
ce
a
worth ment prod l
ucts
$76,22
7
14
December 20
15
January 20
public
Conducted
on
n
tio
ta
ul
ns
co
AN
SE
A
ed
propos
on
t
en
m
ee
gr
A
Medicines
Traditional
Agreement
and ASEAN
pplements
on Health Su
vembe
14
Enforc
e
Opera ment Qua
tions
ntit
Uncov y
ered
Opera
public
Conducted
on the
n
tio
ta
ul
ns
co
e
ansfer of th
tr
d
an
review
r
fo
ls
ro
nt
legislative co
d
rtisement an
medical adve
ng
si
en
lic
y
ac
retail pharm
ts
tical produc
of pharmaceu
d
an
ct
A
es
in
under Medic
to the Health
Poisons Act
Products Act
Date
Novem
ber 20
Septe
13
mber
2014
Augus
t 2014
HOT OFF-THE-PRESS
CRP-CRCS Forum
HSA co-organised the combined Clinical
Research Professionals (CRP) Clinical Research
Coordinator Society (CRCS) Forum held at the
National University of Singapore on
12 December 2014.
The CRP Forum and the CRCS Forum were set up
in 2003 and 2006 respectively to provide a
platform for clinical research professionals from
pharmaceutical companies, contract research
organisations and institutions to network
and keep abreast of the latest developments
in the clinical research industry.
Apart from the fora organised by each group,
combined fora are also organised on a bi-annual
basis to encourage networking between industry and
institution stakeholders. Both groups organised a total of
4 fora in 2014. HSA had the privilege to co-organise the
combined CRP-CRCS Forum with the National Healthcare
Group (NHG) on 12 December 2014. The theme of the
combined CRP-CRCS Forum was Quality by Design.
Speakers from the Health Products Regulation Group
(HPRG) of HSA shared their thoughts about how quality
of clinical trials can be improved by applying quality
assurance upstream of clinical trials as compared to
the traditional downstream approach whereby quality
improvements are made only after quality lapses occur.
Forum Highlights
The forum started off with Ms Angie Sim (Founder, CRP
Forum) and Ms Lim Boon Hwee (Vice Chairperson, CRCS)
welcoming the speakers and participants.
NEX2US
Asst Prof
Raymond Chua,
Group Director of HPRG
and Principal Director of
HSA Academy, delivered
the keynote lecture. Asst
Prof Chua emphasised
the importance of robust
regulations and governance
to safeguard the interests of
trial participants and instil trust
in the safety and quality of the
research framework. The way
forward is to ensure that quality
assurance is involved at the most
early stages to build quality into
the initial design and conduct of
clinical trials, rather than to use
monitoring or audits to address
subsequent quality concerns.
He explained that sponsors should
adopt a risk-based approach in
their quality management plan.
Such an approach should be
used to facilitate proportionate
use of resources by all parties,
by focusing on activities critical
to ensuring human subject
protection and reliability of
trial results.
!
Deficiencies
could be
minimised
if Quality
Assurance had
been involved
right from the
set-up of the
trial or at the
design stage.
Participants
The response was overwhelming with close to 300
participants attending the forum. The audience
enthusiastically volunteered answers for the case studies
presented during the forum and actively participated
during the Question and Answer session.
SPECIAL FEATURE
NEX2US
4 Medcom,
a broker in
Colon, received
46 barrels
of the
poisoned
5
syrup
It was sold
to a Beijing
broker, CNSC
Fortune Way
Company, which
shipped it out
of a port near
Shanghai
The
counterfeit
glycerin
arrived via
container ship
in Barcelona,
where Rasfer
International,
another broker,
took it over
Conclusion
With the growing, globalised pharmaceutical excipient
market and the emergence of more sophisticated excipients,
the regulation of excipients is expected to become more
challenging. Currently, reported cases of adulterated
excipients appear to be limited to DEG-laced glycerin and
propylene glycol.
However, as the excipient industry becomes more
sophisticated and lucrative, temptations to profit unethically
may increase, and other types of economically-motivated
adulterated excipients may manifest. The initiatives from
IPEC are a good start. IPEC could expand its reach to more
countries and collaborate with regulators with a view to
integrate some of its guidelines into legislations.
Source: A Review of the Regulations and International Developments on Quality and Supply Chain Integrity of Pharmaceutical Excipients,
Pharmaceutical Engineering, Nov/Dec 2014 Issue, co-authored by Sia Chong Hock (HSA), Vimal Sachdeva (WHO) and Sean Lee and Chan Lai Wah (NUS).
s
g
n
i
t
e
e
r
CNY G rom us
f
!
A
S
H
at
NEX2US Editoria
l Team
ld
f HSA, I wou
On behalf o
all of our
like to wish
ers
rs and partn
stakeholde
ng
li
y and fulfil
a very happ
to
ld also like
2015. I wou
to
y
it
portun
take this op
nar
warmest Lu
extend our
reetings to
New Year g
l
r a successfu
everyone fo
k
. We loo
year ahead
working
forward to
gaging our
with and en
rs and
stakeholde
further
partners to
r health
enhance ou
gulatory
products re
and service
framework
standards.
oong
Dr Mimi Ctihve Officer
Chief Execu
ty
ces Authori
Health Scien
Executive Editor,
,
,
,
,
,
!
Asst Prof Raymond Chua
Group Director,
Health Products Regulation
Group
NEX2US newslett
er
sperity
HSA wishes you good health, lasting pro
s
and great success in all your endeavour
in the coming Chinese New Year.
Wishing our
stakeholders and
partners a happy
and prosperous
Lunar New Year!
ss
Heres toasting to bundles of joy, happine
,
you
to
and good luck in this Year of the Goat
from all of us at HSA Connects Centre!
ng
Officers,
Kenny and Natalie, Customer Service
HSA Connects Centre
I would lik
e to wish
all
HPRG sta
keh
prosperou olders a
sa
lunar New nd successful
Year of th
e Goat!
May this N
ew Year b
ring
our collab
orative
partnersh
ip in safe
gu
public he
alth and s arding
afety to
greater h
eights!.
Ms Lee Hu
i Keng
Assistant
Gro
Health Pro up Director,
ducts Reg
ulation G
roup
Team
Deputy Director,
Service Management and Industry
Development Office
Ms Stella Ee
Ms Christine Ho
Regulatory Manager,
Vigilance and Compliance Branch
Mr Ashton Quek
EVENT HIGHLIGHTS
Mr Zamane Abdul Rahman (far left), Chairman of the ACCSQMDPWG Meeting, addressing the delegates
10
NEX2US
EVENT HIGHLIGHTS
11
INTERNATIONAL ENGAGEMENT
12
NEX2US
REGULATORY UPDATES
Above: SMF
Medical
Technology
Industry
Group
(MTIG)
13
REGULATORY UPDATES
These refinements
are part of the
initiatives aimed
at enhancing
the compliance
to regulations
involving
medical devices.
14
NEX2US
15
We wel
your fe come
edback
!
Please
REGULATORY UPDATES
em
Editoria ail the
l
HSA_H Team at
PRG_N
@hsa
.gov.sg EX2US
or
at the
followin mail us
g addr
NEX2U
ess:
S New
sletter
Health
,
P
Regula roducts
ti
11 Biop on Group,
olis W
ay
Helios
, Singa , #11-01
pore 13
8667.
Y
ou r N e
Your C wsl et te r
ommen
ts
Regulatory Seminar for A*STAR Researchers and Innovators on Medical Device Regulations
The Regulatory Framework on Medical Device Development 2014 Seminar was jointly organised by A*STAR,
Diagnostics Development (DxD) Hub and HSA on 28 November 2014. It aims to address the questions and concerns
from the scientific, clinical research start-ups and Small Medium Enterprise (SME) community regarding the medical
device regulatory framework and requirements, especially in the Singapore context. It covered common regulatory
challenges faced in the industry and possible ways to address them.
FUN LEARNING
es
Past Issu
2US
of the NEX r
Newslette
E-services
and Forms
Safety
Information &
Product Recalls
Fees
and Charges
for Licences
& Certificates
issued by
Health
Products
Regulation
Group
PRISM
E-services
Industry and
Stakeholder
Engagement
Regula
to
Guidan ry
ce
MEDICS
E-services
Provide
Feedback &
Comments
Singapore
Medical
Device
Register
(SMDR)
Report an
Adverse Event
For Medical
Advertisement
Enquiries
Adverse Drug
Reaction
News Bulletin
Info-search for
Health Products
& Services
on
Guidelines g,
rin
Manufactu &
n
io
Importat
ion
Distribut
The contents are not to be reproduced in part or in whole, without prior written approval from the editor. Whilst every effort is made in compiling the content of this publication, the publishers, editors and authors
accept no liability whatsoever for the consequences of any inaccurate or misleading data, opinions or statements. The mention of any product by the authors does not imply any official endorsement of the product
by the Health Sciences Authority.
Copyright 2015 Health Sciences Authority of Singapore. All Rights Reserved.