Regulatory Affairs · Short notes

Drug Registration in Pakistan: Short Notes & Cheat Sheet

Who registers drugs in Pakistan, the CTD dossier, what is assessed, validity and renewal, and related registrations for devices and health products.

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Short notes

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Registering a drug with DRAP

Details change with DRAP guidance; the overall path from licensed site to registered product stays the same.

The system

A drug may be manufactured, imported or sold in Pakistan only if it is registered, under the Drugs Act 1976.
Registration decisions are made by the Registration Board, which functions within the Drug Regulatory Authority of Pakistan (DRAP).
Local manufacturers can register products only for a site holding a valid manufacturing licence and a suitable section (e.g. tablets, sterile, penicillin).
Imported products need evidence that they are approved and marketed in the country of origin (e.g. a Certificate of Pharmaceutical Product, CoPP) and that the maker follows GMP.

The dossier

Applications for registration of pharmaceutical drugs are made on Form 5-F in the Common Technical Document (CTD) format, which has five modules.
Evaluation summaries are presented to DRAP's Registration Board for its decision.
Module 1 is regional administrative information (application, labelling, fees). Module 2 holds summaries.
Module 3 covers quality: drug substance and product manufacture, specifications, validation and stability.
Module 4 covers non-clinical studies and module 5 clinical studies. Generics rely mainly on module 3 plus bioequivalence where required.
Stability data must reflect Pakistan's hot, humid climate (ICH zone IV conditions).

After approval

Registration is valid for 5 years unless cancelled or suspended earlier. Renewal is applied for on Form 5-B.
If renewal is applied for in time, the registration stays valid until the Registration Board decides.
Changes after approval (site, formulation, pack, shelf life) need variation approval from DRAP before implementation.
Registered products carry a registration number on the label.
Medical devices, alternative medicines and health products (nutraceuticals, herbal products) have their own DRAP rules for enlistment or registration.
Rules and procedures change often, so always check DRAP's current guidance before relying on details.

Cheat sheet

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

CTD modules

Module	Content
1	Regional administrative information
2	Summaries (quality, non-clinical, clinical)
3	Quality (CMC)
4	Non-clinical study reports
5	Clinical study reports

Who does what

Body	Role
Registration Board (DRAP)	Grants drug registration
Central Licensing Board (DRAP)	Grants manufacturing licences
DRAP	Overall federal regulator of therapeutic goods
Provincial health departments	Sale licences, provincial enforcement

Forms and validity

Item	Detail
New registration (pharmaceutical)	Form 5-F, CTD format
Renewal of registration	Form 5-B
Registration validity	5 years
Renewal filed on time	Stays valid until Board decides

Memory aids

CTD: 1 Admin, 2 Summary, 3 Quality, 4 Animals, 5 Humans: The order of the five CTD modules.
5-F to File, 5-B to renew (Back again): Form 5-F for a new CTD registration; Form 5-B for renewal.

Exam traps

Module 1 is region-specific; modules 2–5 are common to all ICH-style submissions.
Registration and licensing are different: products are registered; manufacturing sites are licensed.
An imported product must be approved in its country of origin before it can be registered.
Post-approval changes need approval before they are implemented.

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