Intro to HPR

Question 1

Do hand sanitisers and health supplements require prior HSA approval?

Answer 1

No

Question 2

What kind of requirements are hand sanitisers and health supplements subjected to?

Answer 2

Safety and quality standard

Question 3

For traditional medicine, the ___ of the herbal ingredients is established through real world use over many years, hence, ____ is not necessary.

Answer 3

safety; clinical testing

Question 4

For cosmetic products containing a novel ingredient, the ___ of the ingredient would need to be established through non-clinical testing, but _____ is not critical.

Answer 4

safety; efficacy testing

Question 5

Non-clinical testing does not require____ approval, but must comply with established standards such as _____.

Answer 5

regulatory; good laboratory practice

Question 6

Relevant approvals for product testing

Answer 6

1. Clinical trial authorisation
2. IRB approval
3. Good laboratory / clinical practice

Question 7

Relevant licence/ practice for manufacture & import

Answer 7

1. Active ingredient dealer licence
2. Product manufacturer’s / importer’s licence
3. GMP/ GDP

Question 8

Relevant licence/ practice for product supply

Answer 8

1. Wholesaler’s / retail pharmacy licence
2. GDP
3. Retail level access controls

Question 9

Examples of higher risk health products

Answer 9

TPs, CTGTP, medical device

Question 10

Examples of lower risk health products

Answer 10

Traditional medicines, health supplements, topical antiseptics, and cosmetic products

Question 11

Which higher risk health product do not require clinical trial approval?

Answer 11

Medical devices, in view of the iterative nature of product development

Question 12

Key controls for lower risk health products

Answer 12

• Advertisement controls
• Post-market duties (report of product defect & AE, product recall)

Question 13

Which lower risk health product require clinical trial approval?

Answer 13

Traditional medicines

Question 14

In Health Products (Therapeutic Products) Regulations, the First Schedule contains a list of ______

Answer 14

psychotropic substances

Question 15

The____ Act is the oldest of the existing set of laws relevant to health products.

Answer 15

Sale of Drugs

Question 16

Intent of Sales of Drugs Act

Answer 16

To ensure that consumers were supplied with “drugs” that were of the quantity and quality requested or expected by them.

Question 17

What is the Sales of Drugs Act about

Answer 17

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.

Question 18

Is HSA considering to repeal Sales of Drugs Act, and why?

Answer 18

Yes, as its provisions are outdated and newer health product laws can fulfil the same intent

Question 19

Intent of Poisons Act

Answer 19

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.

Question 20

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 ______

Answer 20

1999; Environmental Pollution Control Act.

Question 21

“Poisons” that are regulated under the Poisons Act are listed in _____ to the Act

Answer 21

The Schedule

Question 21

Scope of Poisons Act

Answer 21

It is “an Act to regulate the importation, possession, manufacture, compounding, storage, transport and sale of poisons.”

Question 21

The controls under the Medicines Act are being transferred in phases to the _____, which is more versatile in providing controls for _____.

Answer 21

Health Products Act; new emerging types of health products

Question 21

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.

Answer 21

Health Products Act

Question 22

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.

Answer 22

section 15; Health Products (Therapeutic Products) Regulations

Question 23

Rule___ of the Poisons Rules provide for the exemption for groups of items as described in the ____ of Poisons Rules.

Answer 23

14; Second Schedule

Question 24

Examples of items exempted under the Second Schedule of Poisons Rules

Answer 24

medical devices, therapeutic products, and CTGT products

Question 25

Scope of “medicinal product” in the Medicines Act does not include..

Answer 25

• 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.

Question 26

Subsets of medicinal products exempted from licensing controls under the Medicines Act

Answer 26

CPM, traditional medicine, quasi-medicinal product, medicated oil and balm, homoeopathic medicine, and topical antiseptic

Question 27

Why are there currently no products regulated through section 54 of the Medicines Act?

Answer 27

the controls for cosmetic products and oral dental gums have been transferred to the Health Products Act in 2007 and 2016, respectively.

Question 28

Definition of “health product” in section 2 subsection (1) of the Health Products Act

Answer 28

1. the substance, preparation or device is for use by humans solely or principally for a health-related purpose.
2. it falls within any of the categories of health products specified in the First Schedule

Question 29

What are the 5 product categories specified in the First Schedule of HPA

Answer 29

Medical devices, cosmetic products, therapeutic products, oral dental gums, and CTGT products.