What is Regulatory Science?
Scientific and technical foundations upon which regulations are based in various industries – particularly those involving health or safety.
~ Wikipedia
What is pharmaceutical regulatory affairs?
Hint: Regulation is a profession
Pharmaceutical regulatory affairs is a PROFESSION which acts as the interface between pharmaceutical industries and drug regulatory authorities around the world.
Industries - Regulatory Affairs - Regulatory Authorities
What is ICH?
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
ICH’s mission is:
To achieve greater ________ worldwide to ensure that ____________ medicines are developed and registered in the most __________ manner.
harmonisation;
safe, effective and high quality;
resource-efficient
Which year was HSA accepted into ICH?
2017
What are the implications of HSA’s acceptance into ICH?
- HSA earned international recognition as a country with an advanced regulatory system for pharmaceutical products.
- SG’s views will be represented when developing ICH guidelines.
- Facilitate entry of local pharmaceutical and biotech industries into other markets.
- Faster development of drugs and quicker access to new therapies for Singaporeans.
What are the 4 categories of topics in the ICH guidelines?
Hint: Q-SEM
- Quality
- Safety
- Efficacy
- Multidisciplinary
What is QSEM in the ICH guidelines?
- Quality
- Safety
- Efficacy
- Multidisciplinary
How does harmonisation lead to better health?
- Prevent unnecessary duplication of clinical trials and post-market clinical evaluations.
- Development & manufacturing of new medicines
- Registration & supervision of new medicines
- Reduction of unnecessary animal testing without compromising safety & efficacy.
