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Yes, as its provisions are outdated and newer health product laws can fulfil the same intent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
Based on the power conferred by _____ of the Health Products Act, an exception was made under the_____ for the supply of emergency therapeutic products for or on behalf of the Government.
section 15; Health Products (Therapeutic Products) Regulations
Rule___ of the Poisons Rules provide for the exemption for groups of items as described in the ____ of Poisons Rules.
14; Second Schedule
Examples of items exempted under the Second Schedule of Poisons Rules
medical devices, therapeutic products, and CTGT products
Scope of “medicinal product” in the Medicines Act does not include..
- Medical devices and equipment
- New substances in early research and development;
- Dental fillings and material
- Plain bandages and surgical dressings not containing medication,
and other items specified by the Minister.
Subsets of medicinal products exempted from licensing controls under the Medicines Act
CPM, traditional medicine, quasi-medicinal product, medicated oil and balm, homoeopathic medicine, and topical antiseptic
Why are there currently no products regulated through section 54 of the Medicines Act?
the controls for cosmetic products and oral dental gums have been transferred to the Health Products Act in 2007 and 2016, respectively.
Definition of “health product” in section 2 subsection (1) of the Health Products Act
- the substance, preparation or device is for use by humans solely or principally for a health-related purpose.
- it falls within any of the categories of health products specified in the First Schedule
What are the 5 product categories specified in the First Schedule of HPA
Medical devices, cosmetic products, therapeutic products, oral dental gums, and CTGT products.
