Intro to HPR Flashcards
Do hand sanitisers and health supplements require prior HSA approval?
No
What kind of requirements are hand sanitisers and health supplements subjected to?
Safety and quality standard
For traditional medicine, the ___ of the herbal ingredients is established through real world use over many years, hence, ____ is not necessary.
safety; clinical testing
For cosmetic products containing a novel ingredient, the ___ of the ingredient would need to be established through non-clinical testing, but _____ is not critical.
safety; efficacy testing
Non-clinical testing does not require____ approval, but must comply with established standards such as _____.
regulatory; good laboratory practice
Relevant approvals for product testing
- Clinical trial authorisation
- IRB approval
- Good laboratory / clinical practice
Relevant licence/ practice for manufacture & import
- Active ingredient dealer licence
- Product manufacturer’s / importer’s licence
- GMP/ GDP
Relevant licence/ practice for product supply
- Wholesaler’s / retail pharmacy licence
- GDP
- Retail level access controls
Examples of higher risk health products
TPs, CTGTP, medical device
Examples of lower risk health products
Traditional medicines, health supplements, topical antiseptics, and cosmetic products
Which higher risk health product do not require clinical trial approval?
Medical devices, in view of the iterative nature of product development
Key controls for lower risk health products
- Advertisement controls
- Post-market duties (report of product defect & AE, product recall)
Which lower risk health product require clinical trial approval?
Traditional medicines
In Health Products (Therapeutic Products) Regulations, the First Schedule contains a list of ______
psychotropic substances
The____ Act is the oldest of the existing set of laws relevant to health products.
Sale of Drugs
Intent of Sales of Drugs Act
To ensure that consumers were supplied with “drugs” that were of the quantity and quality requested or expected by them.
What is the Sales of Drugs Act about
It has a relatively narrow scope that deals with situations where there is a transaction in which a “drug” product or preparation is sold.
It focuses on the concern that the consumer may be defrauded by what he receives from the seller.
Is HSA considering to repeal Sales of Drugs Act, and why?
Yes, as its provisions are outdated and newer health product laws can fulfil the same intent
Intent of Poisons Act
Intended to control the supply of, and access to, substances that are potentially hazardous, to prevent them from causing harm due to accidents or misuse.
The Poisons Act was amended in____ to remove the controls on industrial chemicals, which were moved to a separate piece of legislation, that is, the ______
1999; Environmental Pollution Control Act.
“Poisons” that are regulated under the Poisons Act are listed in _____ to the Act
The Schedule
Scope of Poisons Act
It is “an Act to regulate the importation, possession, manufacture, compounding, storage, transport and sale of poisons.”
The controls under the Medicines Act are being transferred in phases to the _____, which is more versatile in providing controls for _____.
Health Products Act; new emerging types of health products
Relevant controls under the Poisons Act and Medicines (Advertisement and Sale) Act are in the process of being transferred to the _______ and other legislation over time.
Health Products Act
