Regulatory Perspective for Entering GlobalPharma Markets

Ishan Shukla

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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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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North America

USA & CA

Different Applications in USA

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Canada : HSPB Health Products and Food Branch [NDS, ANDS, SNDS ]

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Europe

Different Applications in Europe

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Type of procedures in Europe

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Japan

The approval procedures in Japan

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Other Factors for Consideration

Exclusivities available in major regions

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Contents of Common Technical Document (CTD)

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References

http://www.fda.gov/http://www.ema.europa.euhttp://www.ich.orghttp://www.pmda.go.jphttp://www.hc-sc.gc.ca/http://www.hma.eu/cmdh.htmlhttp://www.asean.orghttp://www.drugterm.comhttp://www.tga.gov.auhttp://www.cdsco.nic.inhttp://www.anvisa.gov.br/eng/index.htmhttp:// www.hsa.gov.sghttp://www.sgh.org.sa/registration.htmhttp:// www.mccza.comhttp:// www.paho.org

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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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Thank You