Initiatives to bring international
information and safety compliance
standards into alignment, meanwhile,
promise to reduce the administrative
complexity for companies trading in
For large- and mid-sized
organizations looking for new growth
opportunities for existing product
lines, or small but ambitious firms
seeking to spread their risk and raise
their profile globally, arguably there
has never been a better time to
broaden their horizons.
Harmonization of industry
requirements isn’t quite there yet,
however. So what are the best
geographical opportunities to
consider in 2018 and beyond, and
what are the current regulatory
peculiarities that companies need
to be aware of as they contemplate
setting up base in those markets?
As the home of European Union (EU)
administration, the Benelux region of
Belgium, the Netherlands, and Luxembourg is an important European
market. Belgium is a major regulatory
hub as well as an open environment
that is research friendly.
Belgium’s language diversity
makes it a useful base from which to
support other European countries
and to liaise with headquarters.
Belgian teams typically manage
regulatory filings on behalf of
Luxembourg and the Netherlands.
For companies, the biggest
challenge is the need to have
a single responsible person for
pharmaceutical information. This
comprehensive role must be filled by
a physician or pharmacist approved
by a country’s ministry of health, and
suitable candidates are hard to find.
The requirement can trip up companies that don’t consider it up front.
As a multilingual country
that is strategically positioned
geographically and that has a
well-established and transparent
regulatory environment, Belgium
represents a progressive hub for
European submission management.
Since joining the EU, Lithuania,
Latvia, and Estonia have adopted
relevant legislation; companies preparing local submissions must have
authorization from each country’s
local authority or from the European
Medicines Agency (EMA) depending
on the type of registration.
In Latvia, the State Agency of
Medicines assesses medicines before
issuing market authorizations. Estonia,
too, has a State Agency of Medicines.
Lithuania’s regulatory body is called
the State Medicines Control Agency.
With a combined population of
around 6. 3 million, the Baltic region
is not known as a significant producer
of pharmaceuticals, and it lags behind
other European markets.
EU legislation requires that a marketing authorization holder reside in
the EU. None of the Baltic countries
requires the presence of a regulatory
person, nor is it necessary to have a
native speaker within each country to
work with authorities, which tend to
communicate in English.
However, it is advisable to have
a native speaker for translations of
summaries of product characteristics
and packaging materials and to provide
advice on product implementation.
Although the Baltic region has seen a
marked decline in mortality rates in the
last 15 years, the rates remain relatively
high for Europe, which presents certain
health-care challenges—as well as
market potential. All three countries are
experiencing pharmaceutical market
growth, with promising potential for
innovative companies that offer new
Compared with more-complex
European markets, the Baltics are
relatively easy to manage from a
distance. The regulatory authorities
are easy to communicate with, and
dossier submission can be managed
electronically via the Common
European Submission Portal/Platform
(CESP), although in Latvia, a signed
paper application form, a cover letter,
and proof of payment are required via
courier or post in parallel.
As the gateway to the African
continent, South Africa is an
important pharmaceutical market
even though its regulatory regime
remains in a state of flux. In June
2017, the government introduced the
Medicines and Related Substances
Amendment Act and is establishing
the new South African Health
Products Regulatory Authority
to oversee medical devices and
medicinal products. This will replace
the Medicines Control Council.
Other moves have included a
transition from the old Medicine
Registration Form format to the
Common Technical Document
(CTD)—mandatory since 2016. Old
dossiers can remain in their existing
Medicine Registration Form format,
but if a chemistry, manufacturing, and
control variation is submitted, the
None of the Baltic countries requires the
presence of a regulatory person, nor is it
necessary to have a native speaker within
each country to work with authorities.