Regulatory Affairs · Short notes

International Regulatory Bodies: Short Notes & Cheat Sheet

ICH, WHO, PIC/S and the major national regulators: what each does and the guideline codes DRAP officer tests ask about.

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Short notes

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The international regulatory landscape

National regulators such as DRAP draw on all of these bodies when setting standards.

ICH

The International Council for Harmonisation brings regulators and industry together to write harmonised technical guidelines.
Guidelines fall into four families: Quality (Q), Safety (S), Efficacy (E) and Multidisciplinary (M).
The Common Technical Document (M4) organises a dossier into five modules.
MedDRA, the medical terminology used in adverse event reporting, is maintained under ICH.

WHO

WHO prequalification assesses medicines and vaccines for procurement by UN agencies and donors.
The Global Benchmarking Tool rates national regulators at maturity levels 1 to 4.
WHO-Listed Authorities are regulators recognised as meeting international standards.
The Certification Scheme provides the Certificate of Pharmaceutical Product (CPP) for exports.
The INN programme gives each active substance a unique generic name.
The Uppsala Monitoring Centre runs VigiBase, the global database of adverse reaction reports.

Inspectorates, pharmacopoeias and regulators

PIC/S is a cooperation scheme between GMP inspectorates sharing standards and training.
EDQM publishes the European Pharmacopoeia and issues Certificates of Suitability (CEPs) for APIs.
Major regulators: FDA (USA), EMA (EU, Amsterdam), MHRA (UK), PMDA (Japan), TGA (Australia), Health Canada.
IMDRF harmonises medical device regulation and succeeded the GHTF.

Cheat sheet

High-yield facts in one place. Cover the right-hand column and test yourself.

ICH codes to know

Code	Topic
Q1A / Q1B	Stability / photostability
Q2	Validation of analytical procedures
Q3A, Q3C, Q3D	Impurities, residual solvents, elemental impurities
Q7	GMP for active pharmaceutical ingredients
Q8, Q9, Q10	Development (QbD), risk management, quality system
E2A–E2E	Pharmacovigilance and safety reporting
E6	Good Clinical Practice
E14	QT prolongation
M4	Common Technical Document
M7	Mutagenic impurities (e.g. nitrosamines)

CTD modules

Module	Content
1	Regional administrative information (not harmonised)
2	Summaries and overviews
3	Quality (chemistry, manufacturing, controls)
4	Non-clinical study reports
5	Clinical study reports

Who does what

Body	Role
WHO PQ	Prequalifies medicines and vaccines
PIC/S	GMP inspectorate cooperation
EDQM	European Pharmacopoeia, CEPs
UMC (Uppsala)	VigiBase, global ADR data
INCB	Controlled drug conventions
IMDRF	Medical device harmonisation

Memory aids

Q S E M = 'Quality Saves Every Medicine': The four ICH families: Quality, Safety, Efficacy, Multidisciplinary.
CTD 3-4-5 = Quality, Animals, Humans: Module 3 quality, 4 non-clinical, 5 clinical; 1 is regional and 2 is summaries.

Exam traps

CTD Module 1 is regional and not harmonised by ICH.
E6 is GCP; Q7 is GMP for APIs, not finished products.
EMA moved from London to Amsterdam in 2019.
A CPP is issued by the exporting country's regulator.

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