controls on advertising and clinical trials

Question 1

controls on advertising for what

Answer 1

• regulate claims made about products
• prevent false or misleading claims
• control claims likely to cause undue worry or alarm concerning health

Question 2

tighter controls on which grp of peopkle

Answer 2

tighter on general public

less controls on ads directed to hcp

Question 3

definition of advertisement

Answer 3

in meds ( ads and sale ) act

and meds act KJ

Question 4

controls for advertisement under the meds ( ads and sale ) act

Answer 4

• 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

Question 5

controls under the meds act for advertising

Answer 5

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

Question 6

under the __ act , cosmetic products shld not be advertised as ___

Answer 6

under hpa, cosmetic subsidiary legislation

cosmetic products shld not be advertised as having a therapeutic effect / benefit

Question 7

what are the advertising controls for MD

Answer 7

must not advertise professional use only unless advertisement distributed to wualified practitioners

Question 8

clinical trials use

Answer 8

products adm to human subject sin investigational setting

Question 9

why must clinicl trials be regulated

Answer 9

protect safety and welfare of trail subjects
prevent unscientific, unethical clinical trials
or have unacceptable risks

Question 10

which acts control clinical trials

Answer 10

Meds act and HPA only

Question 11

what are the parallel controls for clinical trials

Answer 11

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

Question 12

what are the controls for clinical research materials CRM

Answer 12

under r3 of both - no need for product license or registrationa dn no need for dealers license

Question 13

what about med devices as CRM

Answer 13

altho hpa clinical trials regulations dont apply to MD, exemptions for MD from requiring license is provided for as med devices dont need registration

Question 14

do clincal trial materials require licensing or product registration

Answer 14

no

but importers must notify hsa before importing
manufacturers must notify hsa before supplying
dealers must keep records of their CRM

Question 15

do clinical trials need sponsors

Answer 15

every clinical trial must have only 1 sponsor

Question 16

cannot commence the trial unless

Answer 16

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

Question 17

requirements for a clinical trial to be approved

Answer 17

• 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

Question 18

what must clinical trial subjects be informed of

Answer 18

-

Question 19

what kind of consent shld be obtained from clinical trial subjects

Answer 19

written consent in writing
- from subject in person and or his legal representative under certain circumstances
except for emergency trial

Question 20

what happens if serious adverse effect ot usadr

Answer 20

• principal investigator and sponsor must keep all records

if adr - PI must inform sponsor

if usadr sponsor must inform HSA within specified period

Question 21

what labelling is required for clinical trials

Answer 21

• labelling of investigational products and auxiliary products used in clinical trials - r26

Question 22

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

Answer 22

nope

Question 23

what are the main controls for advertising under the meds ( ad and sale ) act

Answer 23

-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

Question 24

clinical trial controls under the HPA only cover

Answer 24

TP and CTGT