L07 Regulatory Affairs (SDL) Flashcards
What is “regulatory science” about?
Developing knowledge, tools, standards & approaches that will help regulatory authorities (e.g. HSA) do their jobs better.
- Impt for developing new medicines
- Speed up development process to ensure safe and effective use of quality-assured medications & improve the diagnosis & Tx of ALL patients
What does “pharmaceutical regulatory affairs” mean?
Profession: Acts as interface between pharmaceutical industries & drug regulatory authorities around the world.
Goals: Protection of human health by:
- Ensuring safety, efficacy & quality of drugs
- Ensuring accuracy of product information
When was the need for pharmaceutical regulatory affairs felt?
Briefly describe the occasion that drove the development of pharmaceutical regulatory affairs.
1950s
Resulting from multiple tragedies:
- Sulfonamide elixir (1937) provoked public outcry and resulted in US FDA 1938 Food, Drug & Cosmetic Act
- Vaccine tragedy
- Thalidomide tragedy (1953): OTC tranquilizer used as sedative & Tx morning sickness in pregnant women, BUT led to peripheral neuritis & killed thousands of ‘thalidomide’ babies, as it was not realised that thalidomide could cross the placental wall & affect fetus
Who formed the basis by which the development of regulatory affairs was driven? What is this basis?
Paracelsus (1493 - 1541):
All substances are poisons, there is none which is not a poison. The right dose differentiates a poison and a remedy.
No drug product is completely safe or efficacious in all circumstances.
- Moral, as well as legal, expectations & steps taken to assure optimal quality, safety & efficacy by manufacturers.
In the current modern era of drug regulations, which organisation do manufacturers worldwide take their reference from to ensure safe & efficacious quality-assured drugs are developed?
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
What is the role & mission of ICH in the modern era of drug regulation?
Role: Bring together regulatory authorities & pharmaceutical industries to discuss scientific & technical aspects of drug regulations.
- Realised the importance to have an independent evaluation of medicinal products before they are allowed on the market
- Albeit at different times in different regions, all were driven by tragedies
Mission: To achieve greater harmonisation worldwide to ensure that safe, effective & high-quality medicines are developed and registered in the most resource-efficient way manner
- Achieved thru development of ICH guidelines via process of scientific consensus w/ regulatory & industry experts working side-by-side.
Explain what drove the establishment of ICH.
Urgent need to rationalise & harmonise regulation impelled by concerns over:
- Rising cost of healthcare
- Escalation of cost of R&D, and
- Need to meet public expectation of minimum delay in making safe & efficacious new Tx available to pt. in need
What are the four main topics covered under the ICH guidelines?
Briefly describe the goal behind developing the guidelines for each topic.
QSEM:
1) Quality: To bring harmonisation in areas such as
- conduct of stability studies,
- defining relevant thresholds for impurities testing &
- more flexible approach to pharmaceutical quality based on GMP & risk management
2) Safety: To uncover potential risks like carcinogenicity, genotoxicity & reprotoxicity before marketing drug to avoid ADR
3) Efficacy: Concern w/ design, conduct, safety & reporting of clinical trials & use of pharmacogenetics techniques to produce better-targeted medicines
4) Multidisciplinary: All about…
- Medical Dictionary for Regulatory Activities (MedDRA)
- Common technical documents (CTD) to assemble all the quality, safety & efficacy information in a common format, and
- Electronic standards of transferring regulatory information.
What are the observers, associates & members of ICH considered as per Global Fund Quality Assurance Policy for Pharmaceutical Products from July 1, 2009?
Stringent regulatory bodies (SRA)
- Many non-profit organisations globally are helping non-SRA regulatory authorities to get stronger.
There is no need to keep up-to-date with drug regulations & developments in the modern age of drug regulation. True or false?
False.
Drug regulation & developments keep changing day by day as per new technologies & safety protocols.
- Key responsibilities of regulatory affairs professionals to remain up-to-date w/ ICH guidelines, CTD, eCTD formats & upcoming technologies.
What are the Articles of Association that ICH stands by?
1) To make recommendations towards achieving greater harmonisation in the interpretation & application of technical guidelines & requirements for pharmaceutical product registration & the maintenance of such registrations
2) To maintain a forum for a constructive dialogue on scientific issues between regulatory authorities and the pharmaceutical industry on the harmonisation of the technical requirements for pharmaceutical products
3) To contribute to the protection of public health in the interest of patients from an international perspective
4) To monitor & update harmonised technical requirements leading to a greater mutual acceptance of research & developmental data
5) To avoid divergent future requirements through harmonisation of selected topics needed as a result of therapeutic advances and the development of new technologies for the production of medicinal products
6) To facilitate the adoption of new or improved technical research & development approaches which update or replace current practices
7) To encourage the implementation & integration of common standards through the dissemination of, the communications of information about & coordination of training on, harmonised guidelines and their use
8) To develop policy for the ICH Medical Dictionary of Regulatory Activities Terminology (MedDRA) whilst ensuring the scientific & technical maintenance, development & dissemination of MedDRA as a standardized dictionary which facilitates the sharing of regulatory information internationally for medicinal products used by humans
Explain the purpose of ICH in the promotion of public health.
Promotion of public health through international harmonisation that contributes to:
1) Prevention of unnecessary duplication of clinical trials & post-market clinical evaluations
2) Development & manufacturing of new medicines
3) Registration & supervision of new medicines
4) Reduction of unnecessary animal testing without compromising safety & effectiveness
accomplished thru Technical Guidelines implemented by the regulatory authorities.
When did HSA first join the ICH?
2008 as an observer
When was HSA accepted as a regulatory member of the ICH?
16-17 Nov 2017 as 9th regulatory member in a meeting held in Geneva
What are the implications behind HSA’s acceptance into ICH?
- Earned international recognition as country w/ advanced regulatory system for pharmaceutical products
- Have first rights to participate in ICH expert working groups
- Have first rights to vote in all matter raised in ICH meetings
- Assures Singapore’s views are represented when developing various ICH guidelines relevant to Singapore (e.g. guidelines determining product registration, manufacturing & safety monitoring)
