The African Continent

Middle Eastern markets

Key markets in Central America, the Caribbean and in Latin America
CIS & other East European markets
South East Asia such as Phillipines and South Asian markets such as Bangladesh, Srilanka, Maldives


NorthAmerica, Europe, Japan are the most regulated pharma markets in the world

Non regulated: USA,Europe&japan


Regulated pharma markets (eg.USA, Europe ) require submission of dossier in CTD format which
has to provide clinical trial and bioequivalence studies. As against this, semi-regulated pharma
markets (South East Asian and Gulf Countries) require ACTD format which does not require
exhaustive details like CTD.

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.
North America (US, Canada)
Europe (Europe Union, Eastern
Europe)
Rest of the World (Asia Pacific minus
Japan, ANZ, GCC, LATAM, CEE,
CIS)
Japan
(LATAM: Latin America; CEE Central
East Europe; CIS Commonwealth
Independent States; ANZ Australia, New
Zealand; ROW Rest of World)

Regulated markets (US, EU, Japan,
ANZ) or Emerging Markets (ROW excluding
ANZ)


North America:
The drug registration procedure in US
is majorly categorized into three parts,
New Drug Applications (NDA), Abbreviated
New Drug Applications (ANDA) and the
mix of both which is widely called as 505
(b)(2) Applications

Japan:
Japan is the worlds second largest
market next to the US

Emerging Nations: Rest of
the World:
This region consists of mainly the
countries from Asia pacific, Latin America,
Eastern Europe, Africa and Gulf countries.


In the ASEAN regions, the applicant
can comply with the common requirements
set in the ASEAN Common Technical
Dossier (ACTD) to get approval in the
member countries (Indonesia, Malaysia,
Philippines, Singapore, Thailand, Brunei,
Myanmar, Cambodia, Laos and Vietnam).


Ministry of Health of GCC states
(Bahrain, Kuwait, Oman, Qatar, Saudi
Arabia and UAE) are regulatory authorities
for the regional pharmaceuticals sector.

Patents Scenario
All developed nations (US, EU, Japan,
ANZ) have established a product patent
which runs for 20 years from the date of
patent filing.

In developing
regions, countries like Brazil, Argentina,
Canada, China, India, Malaysia, Russia,
Taiwan, and South Africa have 20 years of
patent term. The term can be extended up
to 5 years in some of these countries.


Indian Regulations
India being the leading supplier of API
and generic drugs to the world,