Regulatory Affairs Flashcards
Regulatory Science importance (8)
- Develop knowledge, tools, standards and approaches
- Ensure safe, effective and quality of health products
- Important in developing new medicines for diseases like Alzheimer’s disease (AD)
- Predict safety of drugs earlier so patients can be treated earlier or prevent it
- Speed developments of products
- Enhance life through advanced medical devices such as artificial limb (connection of the limb to the brain)
- Understand the mechanism of disease and cause of symptoms
- Personalised medicine
Also keeps food safe by tracking pathogens and link them to their diseases
pharmaceutical products and food
What is Regulatory Science?
Is “the intellectual and practical activity encompassing the systematic study of the structure and behaviour of the regulatory world through observation and experiment to determine the impact of the rules, principles, and laws governing FDA-regulated research”
What is Pharmaceutical Regulatory Affairs?
Maintains regulations from within the pharmaceutical industry
Pharmaceutical Regulatory Affairs importance
- Protection of human health, ensuring safety, efficacy and quality of drugs
- Ensuring accuracy of product information
mainly pharmaceutical products
ICH meaning
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
- International non-profit association
ICH purpose
To bring together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration
ICH mission
To achieve greater harmonisation worldwide to ensure that safe, effective and high quality medicines are developed and registered in the most resource-efficient manner
Benefits of HSA’s membership of ICH (3)
- Facilitate the entry of local pharmaceutical and biotechnology industries into other markets (eg Vietnam & Hong Kong)
- Faster development of drugs and quicker access to new therapies
- Earn international recognition as a country with an advanced regulatory system for pharmaceutical products
ICH promotion of public health (4)
Through international harmonisation that contributes to :
- Prevention of unnecessary duplication of clinical trials and post market clinical evaluations
- Development and manufacturing of new medicines
- Registration and supervision of new medicines
- Reduction of unnecessary animal testing without compromising safety and efficacy
These are accomplished through the implementation of Technical Guidelines by the regulatory authorities