Regulatory affairs self-study

Question 1

What is regulatory science?

Answer 1

Development of knowledge, tools, standards and approaches to help with regulation

Question 2

What are the multidisciplinary guidelines for development of human medicines?

Hint: QSEM

Answer 2

1. Quality (stability, impurities testing, GMP)
2. Safety (Carcinogenicity, Genotoxicity, Repraotoxicity)
3. Efficacy (Clinical trials, pharmacogenetics)
4. Multidisciplinary (MedDRA, CTD, Electronic standards)

Question 3

Regulator science help ensure ____ and _____ of a product?

Answer 3

safety, quality/efficacy

Question 4

How does regulatory science play a part in developing new medicines?

Answer 4

1. Identify the patients which will most likely benefit from usage of those meds
2. Predict safety of drugs earlier to avoid adverse effects

Question 5

What is regulatory affair?

Answer 5

Profession which acts as interface between pharmaceutical industries and Drug regulatory authorities around the world

Question 6

Name some goals of regulatory affairs

Answer 6

1. Protect human health
2. Ensure safety, efficacy and quality of drugs
3. Ensure accuracy of product information

Question 7

What are the purposes of ICH?

Answer 7

Promote public health through international harmonisation that contributes to:

1. prevention of duplication of clinical trials and post-market clinical evaluations
2. Development and manufacturing of new meds
3. Registration and supervision of new meds
4. Reduction of unnecessary animal testing without compromising safety and effectiveness

Question 8

What is MedDRA

Answer 8

Medical Dictionary for regulatory activities, containing highly specific standardised medical terminology developed by ICH to facilitate sharing of reg information

Question 9

ICH step process

Answer 9

1. WG prepares consensus draft of the tehnical document
   2a. Members of ICH assembly invited to endorse document
   2b. Reg members of ICH assembly invited to endorse draft
2. Public consultation by ICH reg members and ICH secretariat. Finalised when regs experts of WG reach consensus
3. Reg members of ICH assembly adopt final ICH harmonised guideline
4. implementation by ICH reg members

Question 10

When was HSA’s membership for ICH announced?

Answer 10

November 2017

Question 11

Benefits of HSA’s ICH membership to local pharmaceutical and biotech industries?

Answer 11

1. Facilitated entry of local pharmaceutical and biotech industries into other markets
2. Faster development of drugs and quicker access to new therapies for patients in Singapore