HPA and related laws Flashcards
(26 cards)
difference btw class 1 & 2 CTGTP
Class 2 CTGT is more than minimally manipulated, non-homologous use, combined with other types of products and are of higher risk than Class I CTGT
what are the various regulations that a TP/ class 1 CTGTP/ class 2 CTGTP/ med device that the clinical trial will be regulated under?
TP, class II CTGTP -> Health Product (Clinical Trials) Regulation
Class I CTGTP, Medical device -> Human Biomedical Research Act
The provisions for clinical trials regulation under both HPA and the Medicines Act run in parallel & are similar
true
Which one of the following about regulatory approval for clinical trial on med device is correct?
1. Regulated under HP(Clinical Trials) Regulations, req regulatory approval for specific trial to be initiated
2. Regulated under HP(CT) Regulation, can only be conducted in research institution notified w MOH
3. Regulated under Human Biomedical Research Act, does not req regulatory approval for specific trial to be initiated
4. Regulated under HBRA, can only be conducted in research institution that has been notified w MOH
3 & 4
An investigator wishes to conduct a clinical trial on a registered diabetes drug, and will be using the drug in accordance with its labelled indication during the trial. In this regard, the drug is expected to pose minimal additional risks to the safety of subjects compared to routine clinical practice. Which of the following approvals from HSA will the investigator be required to apply for?
1. Clinical Trial Authorisation issued under HPA
2. Clinical Trial Notification issued under HPA
3. Clinical Trial Cert issued under Medicines Act
4. Clinical Trial Registration issued under Medicines Act
2
What are the types of health products regulated under the HBRA/ HPA/ MA
HBRA: Class 1 CTGTP & medical device
HPA: TP & Class 2 CTGTP
MA: CPM, traditional medicines
*MA -> defined for use on patients vs HBRA -> use on healthy volunteers
**HP(Clinical Trials) & MA(Clinical Trials) run in parallel
Are studies of health products clinical trials regulated under HPA & MA also regulated under HBRA?
no
What are the manufacturing/ importing/ supplying requirements for CRM
Manufacturers, importers, suppliers of CRM have duties & responsibilities
- Importers/manufacturers of CRM must notify HSA before importing/supplying
- All dealers must keep records of their CRM
Does CRM require licensing & registration?
no
but manufacturer/importer/supplier still have responsibility of informing HSA before importing/ supplying
AND all dealers need to keep record of CRM
State the regulation of clinical trials of medical devices and investigational medical devices
Medical device -> HBRA
Investigation med device -> HP(Med device) Regulation
True/false: one can supply unregistered TP onto ships & aircrafts
True
- pdts dont need to be registered
BUT
requires manufacturer & importers licence
Reg 45 of HP(TP) req registrants of TPs to carry out risk mgmt plans, as directed by HSA, include (select all tt apply):
1. produce & distribute safety info
2. perform clinical studies of TP
3. Withdraw TP from market
4. Implement programmes to restrict supply of TP
1,2,4
What are various exemptions for an “emergency TP”
- Exemption from manufacturer’s licence
- Exemption from importer’s licence
- Exemption from product registration
*product must be registered with HSA when sufficient data is available to support its registration
Wholesaler of med device must inform HSA of completed field safety corrective actions - True/false?
False. (only need inform prior)
Relevant requirements for approval of a pharmacy licence under HP(Licensing of Retail Pharmacies) Reg? (select all tt apply)
1. Secure dispensing area, orderly arrangement of pdts & appropriate storage facilities
2. Proper system for maintenance of records
3. RP must be appointed
4. Under control & mgmt of qualified pharmacist at all times
1,2,4
can a pharmacy that has been licensed under HP(Licensing of Retail Pharmacies) Reg carry out telepharmacy services w/o HSA prior approval?
no
TP that are represented for use by humans but are used off-label for veterinary purposes are regulated under the Animals & Birds Act. True/False?
False
*regulated under HPA
There are prohibitions against the supply of counterfeit products under both HPA & Medicines Act
False
*Health Products Act prohibits the manufacture, import or supply of “counterfeit” health products, under sections 12(5)(b), 13(5)(b) and 16(1)(b) respectively. The older Medicines Act does not provide for equivalent prohibitions relating to counterfeit products.
Exemptions from the prohibitions relating to unwholesome CTGTP can be found in HP(CTGTP) Regulations. True/False?
False
*in HP(Exemptions) Order
Which of the following legislation contain provisions on advertisement controls for HP?
1. Sections 19-23 of HPA
2. HP (TP) Reg
3. HP(CTGTP) Reg
4. HP(Med device) Reg
1&4
Which law provide power for HSA to order a person who has contravened the advertising-related provisions to publish a corrective advertisement in relation to contravening advertisement?
1. Sale of Drug Act
2. Medicines (Advertisement & Sale) Act
3. Medicine Act
4. HPA
HPA
Which legislation(s) regulate advertising of cosmetic products?
HPA & HP(Cosmetic Pdts - ASEAN Cosmetic Directive) Reg
Advertising of ‘professional use only’ medical devices are not permitted, except when advertisement are directed at qualified practitioners. (T/F)
True
Which of the following type of advertisements require a pre-publication permit from HSA?
1. Advertisement on TP
2. Advertisement on medical device
3. Advertisement on CPM
4. Advertisement on topical antiseptic
3&4
