3. Human Drugs
(Pharmaceuticals)
Veterinary Drugs
(Pharmaceuticals)
Human Drugs
(Biologicals including vaccines)
Veterinary Drugs
(Biologicals including vaccines)
Health & OTC
(Alternative medicines)
Medical Devices
(Class A, B, C & D)
Controlled Drugs
(Quota and consumption)
Clinical Trials
(CROs, Protocols)
Therapeutic
goods
What DRAP regulates?
7. Quality Management
System
The management of DRAP has implemented and
committed to continually improve its quality
management system which is established in
accordance to the standards of ISO 9001:2015
and legislative requirements of national
regulatory system for therapeutic goods.
Recognitions
8. United States Pharmacopeia-
Promoting Quality of Medicines
USP –PQM appreciated DRAP for “Adaptation of
CTD will add greater quality and evidence to
submission data,” says DRAP’s CEO. “This will
lead to international harmonization and good
and speedy review practices to improve access
to safe, quality-assured therapeutic goods”
Recognitions
11. Statutory Structure
S.No. Name of Division S.No
.
Name of Division
1 Pharmaceutical Evaluation and
Registration
8 Pharmacy Services
2 Licensing 9 Biological Drug Evaluation and
Research
3 Quality Control and Laboratory
Testing
10 Legal Affairs
4 Price and Costing 11 Management Information System
5 Health and OTC Products (non
drugs)
12 Budget and Accounts
6 Medical Devices and Medicated
Cosmetics
13 Administration, Human Resource and
Logistics
7 Controlled Drugs
11
12. Document No. QMSC/MAN/OC/002 Version 03 Date Issued: 01-May-2022
Organogram
Director,
Pharmaceutical
Evaluation &
Registration
Director,
Drug Licensing
Director,
Biological Drugs
Director,
Health & OTC
Director,
Medical Devices &
Medicated Cosmetics
Director,
Controlled Drugs
Director,
Qual Assurance & Lab
Testing
Director,
Costing & Pricing
Director,
Budget & Accounts
Director,
Admin, HR &
Logistics
Director,
Legal Affairs
Director,
Management
Information System
Director,
Pharmacy Services
Chief Executive
Officer
Drug Regulatory Authority of Pakistan
Policy Board,
DRAP
13. DRAP’s Operations
DRAP
Clinical Trial
approval Registration
of Drugs /
Medical
Devices
Enlistment of
alternate
medicine
Licensing of
manufacturin
g units
cGMP
Inspections
Pharmacovigi
lance
activities
Import
Export
Control
Quality
Control
testing
Lot Release
of Biological
14. Regulatory
Management
ISO 9001:2015
certified
WHO QMS
implementation
Clinical Trials
Bio-Study Rules
2018
ICH GCP standards
Registration /
MA
ICH Common
Technical Document
Bioequivalence
Studies
Compliance
GxP
Inspections
GMP of Schedule
B-II of Drugs
(LRA) Rules 1976
PIC/S GMP ,
Quality Risk
Management
Approach
Quality
Testing / Lot
Release
2 Labs under
strengthening
WHO pre-
qualification of
CDL & NCLB
Market
Surveillance
Random sampling,
surveys and divided
surveillance
Discrete (Distinct)
system with risk-
based post marketing
surveillance
Vigilance
Initial stages of
PV system
Full
implementation
of
Pharmacovigilance
Regulatory Prospects
Current Standards
Future implementation
15. 1
2
3
4Ethical
Regulators should avoid actual or perceived influence by being
open and transparent about their decisions.
RegulatoryGoodPractices
Regulatorydecisionmaking
buildingtrustandconfidenceinregulatorysystem
*Good regulatory practices: guidelines for NRAs for medical products, Working document QAS/16.686, 2016
**A proposed framework for evidence based regulations, working paper, The George Washington University, 2018
Legitimate
Regulations and regulatory decisions should be in line with the
applicable laws of the land.
**
Evidence-based
The scientific and technical basis of regulation should be objective,
empirical, data driven and accessible.
DRAP’s Regulatory Good Practices
Impartiality
Regulations and regulatory decisions should be impartial in order to
be fair and to avoid conflicts of interest.
16. Mission:
To ensure access of safe, quality and efficacious medicine at affordable prices and earliest
availability of new treatment opportunities for the people of Pakistan, Working as a highly
Professional & world class Regulatory Organization at par with international standards and
best practices, through effective management, regulations and enforcement and to support
national health system management through effective therapeutic goods management and
strategies.
Future
At par with
International
standards
Enforcement
Spurious,
Counterfeit,
Unregistered
Automation
Digitalization
and
Integration
Operations
Licensing,
Registration,
Inspection
Regulations
Rules,
Regulations
and SROs
Evolution of DRAP-Approach
17. Legal Framework
• DRAP Act 2012
• Drugs Act 1976
• Alternative Medicines and Health Products (Enlistment) Rules, 2014
• Medical Devices Rules, 2017
• Barcoding Rules, 2017
• CTD (Amendment in LRA Rules), 2017
• Biostudy Rules, 2018
• Ethical Marketing to Healthcare Professional Rules 2021
• Pharmacovigilance Rules, 2022
Rules and Regulations
18. Automation
Electronic Systems including:
• E-Office, DRAP is completely automated
• Pakistan Integrated Regulatory Information
Management System (PIRIMS)
• Online Import Export Application System
(OIES)
• Track and Trace (DRIS)
• Medical Devices Establishment Licensing
System
• VigiFlow Database for ADRs
• Online NOC / Permission for import
of Personal Use Drugs
www.dra.gov.pk
19. New initiatives for ease of business- Automation
Automation of DRAP
● E-Office
● PIRIMS
● Online application system;
● Database Management;
● Online Fee submission
● Digitization
Online I&E Activities
● Facilitates Patients
● Central License and NOC issuance
● Import/Export facilitation
Safety App
● Collaboration of WHO &
EMA, UK
● Safety Alerts
● Reporting of side effects
