2. • A regulatory affair (RA) is a profession which acts as the interface
between the pharmaceutical industry and drug regulatory authorities
across the world.
It is mainly involved in the registration of drug products in the
respective countries prior to their marketing.
The current Pharmaceutical Industry is well organized, systematic and
compliant to international regulatory standards for the manufacturing
of Chemical and Biological drugs for human and veterinary
consumption as well as medical devices, traditional herbal products
and cosmetics.
Introduction
3. In present regulatory scenario, company require Experts
in regulatory activities to manage the product life cycle.
Regulatory affairs experts are the qualified professionals, Legal
advisers to provide right solution to the technical problems
under the light of laws and regulations.
4. • It is the new profession which developed from the desire of the
government to protect public health by controlling the safety and
efficacy of the product in the area including:-
Pharmaceuticals, Veterinary Medicines,
Medical Devices, Pesticides,
Agrochemical, Cosmetics,
Complementary Medicines
DRUG REGULATORY AFFAIRS
5. It is a dynamic and challenging field in the pharmaceutical industry.
It is an affair between the competent and an applicant (company) to
manage life cycle of the products.
In present regulatory scenario, company requires expert in
regulatory activities to manage the product life cycle.
RA experts are qualified professional to provide the right solution to
the technical problems under the light of laws and regulations.
DRUG REGULATORY AFFAIRS
6. Drug development and in order to develop the most efficient and
safe pharmaceutical products.
The path of drug registration is laid down with good intended but
can be complicated.
Somebody who gather all relevant information in one umbrella to
bring product in the market for sell.
Helps to reduce number of development failures
WHY DRUG REGULATORY AFFAIRS??
7. 1.Create awareness
2.Role of Drug Regulatory Affairs department
in the progress of pharmaceutical industry
3.Responsibilities of Pharmaceutical
Regulatory Affairs Professionals
OBJECTIVES
8. 1. Nature of Pharmaceutical Industry
2.Pharmaceutical RegulatoryAffairs
3.Global Drug Regulatory Bodies
4.Drug Regulatory Authority of Pakistan
5.Drug Regulation in Pakistan
6.Regulatory procedures in Pakistan
7.Pharma Regulatory Professionals
8.Global Pharma Regulatory Professional Associations
SCOPE OF REGULATORY
AFFAIRS
9. Regulatory affairs professionals are employed in industry,
government regulatory authorities and academics.
The wide range of regulatory professionals includes in these areas:
Pharmaceuticals
Medical devices
In-vitro diagnostics
Biologics and biotechnology
Nutritional Products Cosmetics
Veterinary Products
SCOPE OF REGULATORY AFFAIRS
PROFESSIONAL IN INDUSTRIES
11. 1. Ensuring that their companies comply with all of the
system policy and laws pertaining to their business.
2. Working with federal, state, and local regulatory agencies
and working with agencies as the Food and Drug
Administration or European Medicines Agency
(pharmaceuticals and medical devices).
3. Advising their companies on the regulatory aspects and
climate that would affect proposed actions. i .e. describing
the "regulatory climate“ in the region of issues such as the
endorsement of prescription drugs.
ROLES OF REGULATORY AFFAIRS
12. 5.Regulatory affairs plays a crucial role in the pharmaceutical industry
and is involved in all stages of drug development and also after drug
approval and marketing.
6.Pharmaceutical companies use all the data accumulated during
discovery and development stages in order to register the drug and
market the drug.
7.Throughout the development stages, the pharmaceutical company
have to abide by an array of strict rules and guidelines in order to
ensure the safety and efficacy of the drug in humans.
4.Regulatory affairs plays a crucial role in the
pharmaceutical industry and is involved in all stages of drug
development and also after drug approval and marketing.
13. 9.It plays a critical role as the leading department to provide
strategic advice on extremely difficult decision through the life of a
drug.
10.Tokeep working order to meet regulatory commitments
within the health authorities.
11.The Regulatory expert also ensures the maintenance of the
marketing license and leads life cycle such as broadening and
indication of the drug, change of formulation, changes in dosage
etc
8.It plays a critical role as the leading department to provide
strategic advice on extremely difficult decision through the
life of a drug.
15. ON WHAT ISSUE DRA DEPARTMENT
PROVIDE ASSISTANCE???
8
Licensing
Registration
Development
Manufacturing
Quality guidance
Pricing
Marketing …..& many more
GMP
GLP
GCP
Patent
Copyright
Trademark
Pharma-covigilance
16. WHAT ARE THE DOCUMENTS PREPARED AND/ MAINTAINED
BY DRA DEPARTMENTS??
Licence And Certificates Obtained By Drug Regulatory
Authorities. e.g. Mfg. Licence, GMP, ISO Etc.
Common Technical Documents (CTD/eCTD)
Drug Master File,
Clinical Trials Reports, BA/BE Report.
Quality Audits And Reports.
Application for obtaining patent, copyrights and
trademark registration.
......& Many More 9
18. Drug = medicinal product= pharmaceutical product
19.
20. Drug regulatory
affairs
Any activity with drugs
By whom? (the authority)
no (=does not belong to
drug regulatory affairs)
yes
Prior authorisation needed?
Based on which (objective
and subjective) criteria?
Subject to regular control
(quality, inspection)?
By whom? (the authority)
Based on which (objective
and subjective) criteria?
2
0
22. • During the 1950s, many tragedies happened due to the misjudgment of
the personnel during manufacture and some intentional addition of
adulteration of substances into the pharmaceutical product, which has
lead to the death of the patients.
After so many incidents, the regulatory bodies introduced the new laws
and guidelines which improve the quality, safety and efficacy of the
products.
This has also resulted in stricter norms for Marketing Authorization
(MA) and Good Manufacturing Practices (GMPs).
EVOLUTION OF REGULATORY AFFAIRS
23. Regulatory bodies such as the Food and Drugs Administration
(FDA) in the USA are responsible for approving whether a drug
can proceed to clinical trials and whether it should be allowed
to come in to the market or not.
These body has to evaluate the scientific and clinical data to
ensure that the drug can be produced with consistently high
purity, better therapeutic results and it does not have
unaccepted side effects.
It must also approve the labeling of the drug and the directions
for its use or we can say regulatory body has taken interested in
all aspects of a drug designing and its formulation.
REGULATORY BODIES IN THE WORLD
24. REGULATORY BODIES IN THE WORLD
Country Regulatory Body
USA
UK
Australia
India
Canada
Europe
Japan
Food and Drug Administration (FDA)
Medicines and Healthcare Products Regulatory Agency
(MHRA)
Therapeutic Goods Administration(TGA)
Central Drug Standard Control Organization
(CDSCO)
Health Canada
European Medicines Agency (EMEA)
Ministry of Health, Labour & Welfare(MHL
W)
25. India – CDSCO (Central Drug Standard Control Organization)
US – USFDA (United State Food And DrugAdministration)
http://www.fda.gov/
Europe – EMA (European MedicineAgency)
http://www.ema.europa.eu
Australia – TGA(Therapeutic GoodsAdministration)
http://www.tga.gov.au/
United kingdom – MHRA (Medicine And HealthcareRegulatory
Agency)
http://www.mhra.gov.uk
26. Ireland – IMB (Irish Medicine Board)
http://www.imb.ie/
ICH – International Conference On Harmonization
http://www.ich.org/
Japan – MHLW-PMDA (Medicines And Pharmaceutical
Device Agency)
http://www.pmda.go.jp
29. CENTRAL DRUG STANDARD CONTROL ORGANIZATION
VISION
TO PROTECT
AND PROMOTE
PUBLIC HEALTH
IN INDIA
MISSION
TO SAFEGUARDAND
ENHENCE THE
PUBLIC HEALTH BY
ASSURING THE
SAFETY EFFICASY AND
QUALITY..
30. Indian Drug Regulatory System: Government of India
Ministry of Health
& Family Welfare
DGHS
Central Drugs
Standard Control
Organization
(CDSCO)
Ministry of Science
& Technology
Indian Council
of Medical
Research
(ICMR)
Council of
Scientific &
Industrial
Research
(CSIR)
BARC
(Radioactive)
Ministry of
Chemicals &
Petrochemicals
National
Pharmaceutical
PricingAuthority
(NPPA)
Department of
Chemical &
Petrochemicals
(DCP)
Department of
Pharmaceuticals
Ministry of
Commerce &
Industry
Patent
Office
Dept. of
Commerce &
Pharmexil
Controller
General of
Patent
DGFT
Ministry of
Environment &
Forest
GEAC-
[Genetic
Engineering
Approval
Committee]
Department of
Biotechnology
r-DNA
Advisory
Committee
Review
Comm17ittee
Genetic
Manipulation
31. 18
Drug
controller
general (1)
Head Quarter
New drugs
Clinical trials
Imports
Biological
Medical
Devices
Export
QC
Pharmco.Vig
Legal etc
Zonal
Office(6)
GMPAudits
Enforcement
Draw drug
Samples
Sub-zonal (4)
GMP Audits
Coordination
with States
Port
Office(13)
Import
Export
Laboratory(7)
Testing of Drugs
Validation of
Test protocols
Central Drug Standard Control Organization
32. CDSCO OFFICES
Zonal Offices:
Ghaziabad, Mumbai, Chennai, Kolkata, Ahmedabad and
Hyderabad
Sub Zonal Offices:
Chandigarh, Bangalore, Goa and Jammu
Port Offices: (13)
Central Drugs Laboratories – 7
Kolkata, Mumbai, Chennai, Hyderabad, Chandigarh,
Guwahati and Kasauli
Other Labs: NIB, IVRI
33. FUNCTIONS OF CDSCO
20
1
• Approval of New Drugs and Clinical Trials
• Import Registration and Licensing
2
3
• Licensing of Blood Banks, Vaccines, r-DNA products &
Notified Medical Devices
4
• Amendment to D &C Act and Rules
5
• Banning of drugs and cosmetics
6
• Grant of Test License,
• Personal License, NOCs for Export
7
• Testing of Drugs
34. FUNCTIONS OF STATE LICENSING AUTHORITIES
Licensing of Manufacturing Site.
Licensing of Establishment for sale or distribution of
Drugs.
Approval of Drug Testing Laboratories.
Monitoring of Quality of Drugs, Medical Devices
and Cosmetics marketed. 21
35. Regulatory Landscape and Product
development (R&D)
The regulatory strategy and the development plan are
Evolving documents. They should be reviewed and updated
on a regular basis during the product development process.
Step 1:
Properly classify your healthcare product (such as a drug,
a biologic, a medical device or a combination product) so that
you know which regulatory path to take. If in doubt, contact
the appropriate regulatory body to confirm the product type
and how your product is regulated.
36. Step 3:
Determine your healthcare market. This will guide you to the requirements that
are specific to each jurisdiction.
It is important to identify jurisdiction-specific requirements upfront. so that they can be
included early in the product development plan.
Step 4:
Develop your regulatory strategy by identifying the specific regulatory requirements as
well as the possible pathway(s) to take. A thorough understanding of these requirements11
Step 2
Identify the claim of your healthcare product so that you know what
types of studies to conduct to support the claim and your product
label. For instance, changing your claim.
May change the medical device classification which can
lead to different regulatory oversight .
37.
38. Step 5:
Establish a healthcare product development plan.
so that the product requirements can be translated into
action i.e., who does what and by when and for how much.
Such plan should be established collaboratively with input
from different functional groups. It should include key
milestones, critical paths and periodic reviews for “go and
no-go” decisions and be updated periodically.
Step 6:
Execute the product development plan It is subject-matter
experts who possess knowledge of the investigational
product who must carry out (and be responsible for) the
corresponding manufacturing, quality, regulatory, non-
clinical and clinical programs, as well as any coordination
with third parties
39. Step 9:
Collate your regulatory submission according to
applicable regulatory requirements specific to your type of
submission.
Ensure the completeness of the submission and
anticipate the resources needed to address questions from
the agency during the submission review.
For an innovative healthcare product, it is often
recommended to have a pre-submission meeting with your
agency prior to submitting the licensing application.
post-marketing
Step 10:
Ensure post-marketing compliance.
Make sure to fulfill all necessary
obligations.
40. Quality Management System and Regulatory Compliance
Management
A quality management system (QMS) is a collection
of business processes focused
policy and quality
requirements. It is
objectives
expressed
on achieving quality
to meet customer
as the organizational
structure, policies, procedures, processes and resources
needed to implement quality management as per
regulatory requirement.
41. Quality Management System and Regulatory Compliance
Management
Electronic document management
SOP management
Regulatory submission management
eCTD management
CAPA management
Change control
Deviation management
Complaints management
Audit management
Learning management and training
42. QUALITIES OF A GOOD RA
PROFESSIONAL
Authoritative
Team Player
Decisive
resourceful
Good Communication Skill
Analytical skills.
Good Informational Technology skills
Negotiating Skills
Able to reapply scientific and regulatory principles
Ability to work with other disciplines
Flexible- Always willing to learn.
44. DRUG AND COSMETICS ACT & RULE
Objective:
To Ensure Safety, Efficacy And Quality Of –
Drugs
Biological products
Medical Devices
Cosmetics
Veterinary Drugs. 23
45. WHAT IS REGULATED UNDER THE ACT & RULE
24
Regulated Under The Act:-
Manufacture
Import
Distribution
Sale
Regulated Under Rules
New Drugs
Exports
Clinical Trials
46. ADMINISTRATION OF ACT
Advisory
* Drugs Technical Advisory Board
* Drugs Consultative Committee
Executive
*LicensingAuthority
*ControllingAuthority
*Drugs Inspector
Analytical
*Central Drugs Laboratories
*Drugs Control Laboratories in States
*GovernmentAnalyst
25
47. STANDARD OF THE DRUG AND COSMETICS
Schedule ToThe Act:-
First Schedule:- Name Of Book Under Ayurvedic,
Unani and Siddha.
Second Schedule:- Improved Drugs And By Drugs
Manufactured, Stocked For Sale.
Schedule ToThe Rules:- (Some Important)
27
schedule Rule for
C Biological And Other Special
Product By Special Provision
C1 List Of Other Special Product
F Operation Of The Blood BankAnd
Component, Vaccines
48. 28
Schedules Rule for
H List Of Prescription Drug
M GMP Requirements
O Standard For Disinfectant Fluid
P Life Period Of Drug
R Standard For Mechanical
Contraceptives
T Requirements Of Factory Premises
And Hygienic Condition
Y Guidelines For Clinical Trials
W Marketed Under Generic Names
49. OTHER ACTS AND ORDERS
Drugs Price Control Order (DPCO):
To ensure drugs are sold at the prescribed prices,
offenders are being monitored.
Shortage and non-availability of drugs brought to
the notice of manufacturers.
Drugs and Magic Remedies Act:
To monitor false/misleading advertisements.
Narcotic and Psychotropic Substances Act:
To prevent Pharmaceutical abuse. 29
50. Challenges
The major challenges of these regulatory bodies are
*To promote public health and protect the public from harmful and
dubious drugs,
*To establish proper legalization covering all products with a
medicinal claim and all relevant pharmaceutical activities,
whether carried out by the public or the private sector.
* To increase worldwide regulatory growth to ensure
safety of people.
51. Regulatory Affairs departments are growing within
companies. Due to the changing resources necessary to
fulfill the regulatory requirements, some companies also
choose to outsource or out task regulatory affairs to
external service providers.
In today’s competitive environment the reduction of the
time taken to reach the market is critical to a product’s
and hence the company’s success. The proper conduct
of its Regulatory Affairs activities is therefore of
considerable economic importance for the company.
CONCLUSION
