The document summarizes regulatory perspectives for entering global pharmaceutical markets. It discusses projections that the global pharmaceutical market will reach between $1.135 trillion and $1.235 trillion by 2017, with the United States holding the largest market share at 31% and emerging markets accounting for an increasing portion. It then provides an overview of drug regulations, noting they vary between regions but aim to protect public health. The regulatory approval processes and requirements in major markets like the US, Europe, Japan, and other regions are then outlined.

1. Regulatory
Perspective for
Entering Global
Pharma Markets
Ishan Shukla

2. Crunching the numbers• IMS projects that the global pharmaceutical market (ex
manufacturer prices, not including rebates and discounts)
will reach between $1.135 trillion and $1.235 trillion by
2017 (see Figure 1).
• The United States will hold the number one position
with a 31% market share. If traditional Chinese medicines
are considered, China will move into the number two spot
with a 15% share followed by Japan with a 9% share. If
traditional Chinese medicines are excluded, Japan will
retain the number two spot.
• The pharmaceutical markets of the EU5 (France,
Germany, Italy, Spain, and United Kingdom) collectively
are projected to hold a 13% share, and the
pharmaceutical markets of Brazil, Russia, and India will
collectively hold 8%.
• Tier 3 Pharmerging countries (defined by IMS as Algeria,
Argentina, Colombia, Egypt, Indonesia, Mexico, Nigeria,
Pakistan, Poland, Romania, Saudi Arabia, South Africa,
Thailand, Turkey, Ukraine, Venezuela, and Vietnam) are
projected to hold a 10% share by 2017.
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3. Drug Regulations
• The pharmaceutical industry is one of the highly regulated industries, to protect the health and well being of the masses.
• The structures of drug regulation that exist today i.e. drug laws, drug regulatory agencies, drug evaluation boards, quality control
laboratories, drug information centres, etc., have evolved over time in response both to the increasingly sophisticated
pharmaceutical sector, and to the apparent needs of society.
• While drug laws provide the basis for drug regulation, regulatory tools such as standards and guidelines equip drug regulatory
authorities with the practical means of implementing those laws.
• Though the world pharmaceutical regulations are in continuous process of harmonization, they can be divided into four major
categories based on the region, development strategy, regulations and marketing interest.
1. North America (US, Canada)
2. Europe (Europe Union, Eastern Europe)
3. Rest of the World (Asia Pacific minusJapan, ANZ, GCC, LATAM, CEE,CIS)
4. Japan
(LATAM: Latin America;
CEE – Central East Europe;
CIS – Common wealth Independent States;
ANZ – Australia, New Zealand;
ROW – Rest of World)
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4. North America
USA&CA

5. Different Applications in USA
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6. Canada : HSPB Health Products and
Food Branch [NDS, ANDS, SNDS ]
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7. Europe

8. Different Applications in Europe
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9. Type of procedures in Europe
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10. Japan

11. The approval procedures in Japan
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12. Other Factors for Consideration

13. Exclusivitiesavailableinmajorregions
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14. Contents of Common Technical
Document (CTD)
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15. References
http://www.fda.gov/
http://www.ema.europa.eu
http://www.ich.org
http://www.pmda.go.jp
http://www.hc-sc.gc.ca/
http://www.hma.eu/cmdh.html
http://www.asean.org
http://www.drugterm.com
http://www.tga.gov.au
http://www.cdsco.nic.in
http://www.anvisa.gov.br/eng/index.htm
http:// www.hsa.gov.sg
http://www.sgh.org.sa/registration.htm
http:// www.mccza.com
http:// www.paho.org 16

16. Indian Regulations
• Drugs and Cosmetics Act 1940 and Rules 1945.
• There are some necessary licenses to be obtained as mentioned in the
table for developing and exporting the drug products.
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17. Thank You