LEC 3

Question 1

Why is there a need to define T/HMP?

Answer 1

This is because there are many definitions which varies across the countries.

Question 2

Why is there a need to have a harmonised standards for T/HMP?

Answer 2

This is because the standards used to regulate T/HMP varies from countries to countries.

Question 3

Herbal medicinal products

Answer 3

Contains 1 or more herbal substances as active ingredients.

The active ingredients (herbal substances) are not synthetic.

Question 4

Traditional medicinal products

Answer 4

Contains 1 or more substances from animal, herbal or mineral origin.
The active ingredients are not synthetic.

Question 5

Health products that are NOT T/HMP

Answer 5

1. Drug products (chemically synthesised)
2. Biological and biotechnology-derived medicinal products
3. Medical devices
4. Cosmetics
5. Dietary, food and nutritional supplements

Question 6

Limitations of current regulatory status of T/HMP (3)

Answer 6

1. Lack of harmonisation of GMP standards
2. Minimal product quality requirements
3. Does not include certain product quality attributes
   eg control of API, contaminants and container-closure systems

Question 7

How to overcome the lack of harmonisation of GMP standards?

Answer 7

The implementation of PIC/S which contains 9 chapters and 20 annexes. One of the annexes (7) covers on GMP compliance.

Question 8

How to overcome the lack of harmonisation of product quality?

Answer 8

Hence, European Medicines Agency (EMA) Guidance Notes on quality of herbal medicinal product can help to standardise the quality of products.
Traditional and historical use of T/HMP can show efficacy and safety but does not show product quality.
eg QC water quality

Question 9

Strategies to combat adulterated T/HMP (7)

Answer 9

1. Suspect the type of adulterants that would be present in the product from its product indication
   eg ED product might be adulterated with sildenafil, weight loss product with sibutramine
2. Test for their analogues as well
3. Educate consumers and public on diseases which might not be treatable eg diabetes
4. Increase industry vigilance
5. Exchange of informations and alerts amongst regulators (internationally)
6. Sharing of test methods and references standards for adulterant testing, including their analogues
7. Inspectors can carry out robust GDP/AMP audits regularly and ensure tight supply chain control

Question 10

What are analogues?

Answer 10

• aka designer drugs
• are synthesised to circumvent drug laws
• have similar chemical structures to API of pharmaceutical drugs

Question 11

What are the considerations to level up the T/HMP industry?

Answer 11

Need to balance stakeholders interest to make profits and ensure products are safe and meet quality standards

Question 12

Are T/HMP food/dietary supplements?

Answer 12

No

Question 13

Designer drugs

Answer 13

• drugs that are synthesised illegally

- analogues of therapeutic compounds

Question 14

Challenges and issues in regulating T/HMP may be categorised into the need for (5) :

Answer 14

1. Harmonisation of GMP standards for T/HMP
2. Harmonisation of quality standards for T/HMP
3. Combating adulterated T/HMP
4. Levelling up of (cottage) T/HMP industry
5. Implementation of GACP (Good Agricultural & Collection Practice)