Exam aid · Exam-specific: DRAP and PFSA

DRAP & Regulatory Affairs

Who decides what, which law covers which product, and the international codes DRAP officer and Drug Inspector papers ask about.

Tables to memorise

Cover the right-hand column and test yourself before checking.

Law / rules	Covers
Pharmacy Act 1967	Pharmacy councils, education, registration of pharmacists
Drugs Act 1976	Import, manufacture, sale, quality offences, inspectors, Drug Courts
Control of Narcotic Substances Act 1997	Narcotics, psychotropics, precursors
DRAP Act 2012	Establishes DRAP, the federal therapeutic goods regulator
Alternative Medicines and Health Products Rules 2014	Enlistment of herbal, Unani, homeopathic, nutraceuticals
Medical Devices Rules 2017	Device classification, licensing, registration
Bio-Study Rules 2017	Clinical trials and bioequivalence studies
Pharmacovigilance Rules 2022	ADR reporting and MAH safety duties

Body	Decides
DRAP Policy Board	Oversight and policy of the Authority
Registration Board	Registration of drugs
Central Licensing Board	Manufacturing licences
Appellate Board	Appeals against board decisions
Drug Pricing Committee	Price recommendations (notified by federal government)
Provincial Quality Control Board	Prosecution of provincial cases
Drug Court	Trials of offences under the Drugs Act
Provincial licensing authority	Retail and wholesale sale licences
Pharmacy councils	Registration of pharmacists and technicians

Term	Key idea
Spurious	Imitation or substitute; false name or maker
Misbranded	False, misleading or improper labelling
Adulterated	Filthy, decomposed or made in insanitary conditions
Substandard	Fails claimed strength, quality or purity
Counterfeit	Deliberately false identity or source

Item	Fact
Serious ADR	Death, life-threatening, hospitalisation, disability, congenital anomaly
Expedited report	15 calendar days (serious, unexpected)
Causality (WHO-UMC)	Certain, probable, possible, unlikely, conditional, unassessable
Periodic report	PBRER (ICH E2C)
Case report format	ICSR (ICH E2B)
Terminology	MedDRA
Global database	VigiBase (Uppsala Monitoring Centre)

Registration is federal (DRAP); retail licensing is provincial.
Drug registration is valid for five years and must be renewed.
Federal inspectors deal with manufacturers and importers; provincial inspectors with retail and wholesale.
DRAP's National Control Laboratory for Biologicals releases each vaccine lot.
CTD Module 3 = quality, 4 = non-clinical, 5 = clinical; Module 1 is regional.
Medical device classes run from A (lowest risk) to D (highest).

SMAS-C quality offences: Spurious, Misbranded, Adulterated, Substandard, Counterfeit.
R-C-A boards: Registration Board registers, Central Licensing Board licenses, Appellate Board hears appeals.

Attempt MCQs on these topics while the sheet is fresh. Anything you get wrong goes to your incorrect list for the next round.