A business’s primary goal in most cases is to make profits. That
being said, sustainable profits can only occur with expansion, which is why
many ventures explore new markets to capture additional market share. The above
statement applies to all sectors, and the pharmaceutical industry is no
exception.

For pharma companies, venturing into new markets, especially
emerging markets, presents a unique opportunity to make good returns for a
multitude of reasons.

In this post, we explore the intricacies of venturing into new markets for pharma companies and the role of regulators in all of this.  

Steps involved when venturing into new markets

Market entry could either be local or international, so the plan
of action involved in each case could differ to some extent. But irrespective
of the geographical region any business seeks to enter, specific fundamentals
that start from — market research to developing a market entry strategy, and
finally executing said entry strategy — needs to be followed.

Barriers pharma companies face during market entry

Import regulations, government protectionism, high costs,
complex distribution network, etc., are SOME of the barriers to market
entry. 

One major obstacle at play, especially for pharmaceutical
companies, would be the role of the drug regulator in the country of entry.
While some emerging markets may not have strict drug regulation policies, developed
markets like the US and EU have regulatory bodies (FDA and EMA) that impose
strict guidelines on pharmaceutical companies before they can be allowed to
access these markets. 

These guidelines are put in place to ensure the high safety and
efficacy standards of all produced drugs.

Role of pharmaceutical regulations

The
need for safe drugs that are of the highest quality and effectiveness has
justified the need for pharma regulations. 

There
is also the need to reduce asymmetric information between
pharma companies and regulatory bodies on the quality of drugs entering the
market to a minimum in order to forestall harm due to improper administration
of said drugs to patients.

Some
may argue that this could be the bane of the strict policy requirement that
serves as a barrier for market entry on the part of pharma companies.

The
effect of some of these strict policies come in various forms. In a previous post, we
touched on the low number of drug approvals in the U.S., but polices could also
be in the form of the high cost of carrying out research and development for
new drugs. After all, it is said that the average cost of R&D to get a successful new drug into the
market stands around $2.8 Billion. 

The
primary purpose of regulators like the FDA and EMA is the role of granting drug
approval to pharma companies. The process of doing so involves a lot of
information moving back and forth between both parties involved. In cases
involving a foreign company, pharmaceutical
translation services are mandatory in overcoming
language barriers to ensure that no information is lost during translation.

The
process of granting regulatory approval to pharma companies would involve the
regulator to carry out activities like;

1. Quality
   Control

Regulatory
bodies are, in most cases, required by law to monitor the quality of drugs
pharma companies are attempting to bring into their local market. For instance,
the FDA has the Current Good Manufacturing Practice (CGMP)
regulation to maintain minimum
requirements in methods, facilities, and controls employed in the manufacture
of specific drugs. CGMP compliance is a requirement for regulatory approval by
the FDA.

• Another
  role pharma regulation plays in the drug approval process is the review and
  evaluation of drug data.  It involves
  activities like the review of;
• Drug test results
• Data from animal and
  human clinical trials
• Drug effectiveness
  compared to information submitted by pharma companies
• Manufacturer information
  to ensure manufacturing compliance

What does it all mean?

By now, it must be clear to all that the process of getting drug
approval from pharma regulators is not a stroll in the park. The time consuming
and cost-intensive nature of the entire process warrants that every step must
be precise with no error whatsoever.

This implies that pharma companies, asides from adhering to all
regulatory requirements, must ensure that no information is lost along the way
by properly navigating language barriers in healthcare to be able to tap into the
rewards of both emerging and developed markets.

Do you have plans to venture into new markets both in the local
and international scene?

Translationsinlondon has a long
list of professionally certified
translators ready to help you take your business into any of the
foreign markets.

Get in touch with us today by sending us an email