controls on advertising and clinical trials Flashcards
(24 cards)
controls on advertising for what
- regulate claims made about products
- prevent false or misleading claims
- control claims likely to cause undue worry or alarm concerning health
tighter controls on which grp of peopkle
tighter on general public
less controls on ads directed to hcp
definition of advertisement
in meds ( ads and sale ) act
and meds act KJ
controls for advertisement under the meds ( ads and sale ) act
- section 3 and 5
- cant say it claims to cure diseases / abortion/ miscarriage
but excluded control is audience is hcp , those undergoing training or poisons license holder
controls under the meds act for advertising
prohibition against false or misleading ads
=> claims for unauthorised recommendation ( outside its specification )
+> applicable to hcp too ! not only geenral public !
- cannot make claims that it cures the 19 disease
( not applicable to hcp )
+ in subsidiary legislation w regards to permit
- smth abt trade ( clarify )
- must get permit before printing
- must ensure permit number displayed
- cannot alter ad that is already permitted without approval from licensing authority . permit given based on orignal content
under the __ act , cosmetic products shld not be advertised as ___
under hpa, cosmetic subsidiary legislation
cosmetic products shld not be advertised as having a therapeutic effect / benefit
what are the advertising controls for MD
must not advertise professional use only unless advertisement distributed to wualified practitioners
clinical trials use
products adm to human subject sin investigational setting
why must clinicl trials be regulated
protect safety and welfare of trail subjects
prevent unscientific, unethical clinical trials
or have unacceptable risks
which acts control clinical trials
Meds act and HPA only
what are the parallel controls for clinical trials
clinical trials and clinical research materials
trials have their own controls and the materials have their own control
-
controls under HPA apply to therapeutic and CTGT products only
what are the controls for clinical research materials CRM
under r3 of both - no need for product license or registrationa dn no need for dealers license
what about med devices as CRM
altho hpa clinical trials regulations dont apply to MD, exemptions for MD from requiring license is provided for as med devices dont need registration
do clincal trial materials require licensing or product registration
no
but importers must notify hsa before importing
manufacturers must notify hsa before supplying
dealers must keep records of their CRM
do clinical trials need sponsors
every clinical trial must have only 1 sponsor
cannot commence the trial unless
med products , hsa issued clinical trial certificate
for ctgt and therapeutic products :
- have been authorised
- if authorisation not needed eg low risk then hsa has been informed
requirements for a clinical trial to be approved
- undergo ethics review and be approved by instituitional review baord - r7
- prinicpal investigator r5
- conducted according to good clinical practice and approved protocol - r13,r14
- conducted at specific premises r15
what must clinical trial subjects be informed of
-
what kind of consent shld be obtained from clinical trial subjects
written consent in writing
- from subject in person and or his legal representative under certain circumstances
except for emergency trial
what happens if serious adverse effect ot usadr
- principal investigator and sponsor must keep all records
if adr - PI must inform sponsor
if usadr sponsor must inform HSA within specified period
what labelling is required for clinical trials
- labelling of investigational products and auxiliary products used in clinical trials - r26
are product information leaflets supplied with medicinal products, spoken words and labels on medicinal products included in the definition for advertisement under the medicines act
nope
what are the main controls for advertising under the meds ( ad and sale ) act
-prohibition of ads implying curing of 19 conditions
and relating to procuring miscarriage
but not applicable to hcp , hcp in training and poisons license holders
clinical trial controls under the HPA only cover
TP and CTGT
