Pharmaceutical Industry

1
Pharmaceutical Industry Regulations

• Prof.Dr.Pakdee Pothisiri
• Secretary General,
• Thai Food and Drug Administration

20.3.2006
2
Advanced Technologies in Pharmaceutical Industry

• Biotechnology
• Pharmacogenomics
• Genetic Engineering
• Microencapsulation
• Nanotechnology
• etc.

3
19th Century Age of Chemistry
20th Century Age of Physics
21st Century Age of Biology
4
CHEMICAL DRUG TO BIOLOGICAL
DRUG
1990 1995 (83 17)
1997 (77 23)
1999 (70 30)
2001 (34 66)

• Large Molecule (Polypeptide/ Protein)
• Unstable (Store in 2 4 C in Lyophilized
  Powder)
• Mainly By Injection
• Stringent Regulatory Control, No Bio-generic
• Not Allowed API Formulation

• Small Molecule
• Chemically Synthesized
• Very Stable (Store in Room Temp)
• Mainly By Oral
• Less Regulatory Control
• Allowed API Formulation

• Biochemical Drug
• Extraction/ Purification from Living Organism
• Insulin Pig Pancreas
• Albumin Plasma
• Urokinase Urine
• Vaccine Bacteria

• Biotech Drug
• Recombinant Proteins
• rhGH, rhINF, rhInsulin, r-vaccines
• Monoclonal Abs
• Herceptin, Rituxan

of Chemical vs Biological Drug Approved in USA
5
From Research to Market Place
In USA 1015 Years, 300500 MUS
1
5,000 - 10,000
250
5
I N D
N D A
Upstream Research
Pilot Production
GMP Facility
Pre-clinical Study
PL
CT-I
CT-II
CT-III
CT-IV

• Target Gene Screening Selection
• Functional Research of Target Gene
• Protein Structure Character

Formulation Study Scale-up Production SOP

• Efficacy
• Pharmacology
• Toxicity
• Pharmaco-kinetics

Development of New Drug High Cost High Risk High Return Long Duration
Overseas Market Entry will Take Another 23 Years
6
Revolution in Pharmaceutical industry with
Nanotechnology

• Solubility enhancements
• Reduction of RD and manufacturing costs
• Quicker time-to-market (TTM) for new drug
  candidates
• Greater targeting ability that may allow for
  lower dosing requirements, potentially lessened
  side effects

7
Pharmaceutical Situation in Thailand

• Mostly formulation industry
• Mainly supply for local consumption
• Limited export to other countries

8
Government policy

• Promote research and development of new drugs
  and biological products
• Production of APIs
• Expand capability of industry

9
PHARMACEUTICALS SITUATION
Reference Thailand Health Profile, 1999 - 2000
Percentage of Locally Produced and Imported Drugs
(for Human Use) 1983-2000
10
Number of registered drugs in Thailand
Average number of new drugs annually is 100
11
Roles and functions

• Regulate and monitor pharmaceutical products to
  meet quality, safety and efficacy standards.
• Facilitate manufacturers from development to
  marketing authorization
• Improve and increase efficiency of drug
  regulatory system

12
Regulation of Pharmaceutical Products

• The current laws and regulations
• I The Drug Act B.E. 2510 (1967)
• amended by
• - Drug Act (No.2) B.E. 2518 (1975)
• - Drug Act (No.3) B.E. 2522 (1979)
• - Drug Act (No.4) B.E. 2527 (1984)
• - Drug Act (No.5) B.E. 2530 (1987)
• II Number of regulations (active) 14
• III Number of notifications 200

13
Pharmaceutical Regulatory System

• Pre-Marketing Control
• Licensing comply to GMP requirements
• Market approval
• Advertisement clearance
• Clinical research authorization

14
Pharmaceutical Regulatory System

• Post-Marketing Control
• Monitoring and surveillance of pharmaceuticals
• SMP conditional approval new drugs
• General marketed drugs
• (including handling of complaints and product
  recall)
• Pharmacovigilance of ADR
• GMP inspection of existing pharmaceutical
  manufacturing facilities
• Monitoring of Pharmacies
• Monitoring of drug advertisement (general public
  practitioners)

15
Future Trend of Regulatory System

• Implementation of agreements on ASEAN
  harmonization on healthcare products
• Implementation of international GMP (PIC/S)
• Assuring availability of quality Active
  Pharmaceutical Ingredients (API)
• Strengthening local pharmaceutical industry
  capability

16
1 Implementation of Agreements on ASEAN
Harmonization on Healthcare Products

• ASEAN Economic Community (AEC)
• within 2020
• 11 groups of goods including healthcare products
  (eg.pharmaceuticals, cosmetics, etc.)

17
ASEAN Pharmaceutical Harmonization

• . Promote and support drug registration system,
  trade and cooperation in the region
• Eliminate Technical Barrier to Trade (TBT)
  among member countries

18
Roadmap of Pharmaceutical Harmonization

• Feasibility study of ASEAN MRA Schemes
• Establishment of rapid alert system
• Establishment of labeling standards
• Implementation of ASEAN Common Technical Dossier
• Promotion of pharmaceuticals approval process
• Feasibility study of harmonization placement
  system
• Feasibility study of flexible twinning system

19
2 Modernizing GMP Inspection and Practices

• Started campaigning on GMP compliance since
  1984
• Aimed to promote and support local industry to
  comply with GMP requirements
• At present, code of GMP WHO GMP 1992
• Moving forward to become PIC/S member and
  observe WHO GMP 2003 at the end of 2007
• Establishment of Quality System for GMP
  inspection according to ISO Guide 62 and ISO/IEC
  17020

20
Comparison of WHO GMP 1992 with PIC/S GMP

• Mostly the same requirement except
• aseptic process requirement for manufacturing of
  sterile products is different

21
Comparison of WHO GMP 1992 with PIC/S GMP

• Aseptic process requirement (Sterile filter
  products)

22
Comparison of WHO GMP 1992 with PIC/S GMP

• Aseptic process requirement (Other sterile
  products prepared from sterile starting materials)

• PIC/S Particle count both at rest and in
  operate
• WHO Particle count at rest.

23
3 Assuring Availability of Quality API
Strengthening regulatory requirements of
quality API by promulgating new ministerial
notification, regulating manufacturing, importing
and sale of API including requirement for
detailed reports and sale accounts and
development of electronic information linkage.
24
4 Strengthening Local Pharmaceutical Industry
Capability

• Development of essential technical guidelines
  adopting international benchmark
• Promoting collaboration between industry and
  academics on new drug discovery research
• Development of local industry competitiveness
• Capacity building for quality assurance of local
  generics
• Building up IP management capability

25
Partnership with Other International
Organization and Fora

• Bilaterals
• GCG-ICH
• APEC-LSIF
• DCVR network
• WHO/ WTO / WIPO
• Others

26
Thank You